report research about internet

Many of us cannot imagine our lives without the Internet.

But the technology is still young ; only 60% of the world’s population was online in 2020.

The internet provides an almost endless list of services: it allows us to communicate and collaborate worldwide; send money internationally (including remittances ); learn and educate others; form cross-border social connections ; share news; and many others.

You can find all our data, visualizations, and writing on this page relating to the internet.

Related topics

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Esteban Ortiz-Ospina

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Internet Research

Issue(s) available: 164 – From Volume: 1 Issue: 1 , to Volume: 34 Issue: 7

• Issue 7 2024 Open Access Issue in Progress
• Issue 2 2024
• Issue 1 2024 The Opportunities and Challenges in the Metaverse
• Issue 7 2023 Open Access Issue
• Issue 6 2023
• Issue 5 2023 The social, ethical, economic, and political implications of misinformation
• Issue 4 2023
• Issue 3 2023
• Issue 2 2023
• Issue 1 2023
• Issue 7 2022 Open Access Issue
• Issue 6 2022
• Issue 5 2022
• Issue 4 2022
• Issue 3 2022
• Issue 2 2022 Interpretable AI-enabled Online Behavior Analytics
• Issue 1 2022
• Issue 6 2021 The Bright Side and the Dark Side of Digital Health
• Issue 5 2021
• Issue 4 2021
• Issue 3 2021
• Issue 2 2021
• Issue 1 2021
• Issue 6 2020
• Issue 5 2020
• Issue 4 2020
• Issue 3 2020
• Issue 2 2020
• Issue 1 2020
• Issue 6 2019
• Issue 5 2019 The Sharing Economy: Promises and Challenges
• Issue 4 2019
• Issue 3 2019 Internet research using partial least squares
• Issue 2 2019 Online and mobile gaming
• Issue 1 2019
• Issue 5 2018 The Dark Side of Social Media
• Issue 4 2018
• Issue 3 2018
• Issue 2 2018
• Issue 1 2018
• Issue 5 2017
• Issue 4 2017
• Issue 3 2017
• Issue 2 2017
• Issue 1 2017
• Issue 5 2016
• Issue 4 2016
• Issue 3 2016
• Issue 2 2016 Internet of Things
• Issue 1 2016
• Issue 5 2015
• Issue 4 2015
• Issue 3 2015
• Issue 2 2015
• Issue 1 2015
• Issue 5 2014
• Issue 4 2014
• Issue 3 2014
• Issue 2 2014
• Issue 1 2014
• Issue 5 2013 The power of prediction with social media
• Issue 4 2013
• Issue 3 2013
• Issue 2 2013
• Issue 1 2013
• Issue 5 2012
• Issue 4 2012
• Issue 3 2012
• Issue 2 2012
• Issue 1 2012
• Issue 5 2011
• Issue 4 2011
• Issue 3 2011
• Issue 2 2011
• Issue 1 2011
• Issue 5 2010
• Issue 4 2010 Internet Research 20th Anniversary Commemorative Issue
• Issue 3 2010 Intelligent eservices applied to B2C ecommerce
• Issue 2 2010
• Issue 1 2010
• Issue 5 2009
• Issue 4 2009
• Issue 3 2009
• Issue 2 2009 Intelligent ubiquitous computing applications and security issues
• Issue 1 2009
• Issue 5 2008
• Issue 4 2008
• Issue 3 2008
• Issue 2 2008 Information credibility on the web
• Issue 1 2008
• Issue 5 2007 Selected research papers from the TERENA networking conference 2007
• Issue 4 2007
• Issue 3 2007
• Issue 2 2007
• Issue 1 2007 The Sixth International Network Conference INC, 2006
• Issue 5 2006 Apartthemed issue on internet security
• Issue 4 2006
• Issue 3 2006
• Issue 2 2006 Privacy and anonymity in the digital era
• Issue 1 2006
• Issue 5 2005
• Issue 4 2005
• Issue 3 2005
• Issue 2 2005
• Issue 1 2005
• Issue 5 2004
• Issue 4 2004
• Issue 3 2004
• Issue 2 2004
• Issue 1 2004
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• Issue 2 2003
• Issue 1 2003
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• Issue 2 2002
• Issue 1 2002
• Issue 5 2001
• Issue 4 2001
• Issue 3 2001
• Issue 2 2001
• Issue 1 2001
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• Issue 4 2000
• Issue 3 2000
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• Issue 1 2000
• Issue 5 1999
• Issue 4 1999
• Issue 3 1999
• Issue 2 1999
• Issue 1 1999
• Issue 5 1998
• Issue 4 1998
• Issue 3 1998
• Issue 2 1998
• Issue 1 1998
• Issue 4 1997
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• Issue 4 1996
• Issue 2/3 1996
• Issue 1 1996
• Issue 4 1995
• Issue 3 1995
• Issue 2 1995
• Issue 1 1995
• Issue 4 1994
• Issue 3 1994
• Issue 1 1994
• Issue 4 1993
• Issue 3 1993
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• Issue 4 1992
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• Issue 1 1992
• Issue 2 1991
• Issue 1 1991

Spillover effects of data breach on consumer perceptions: evidence from the E-commerce industry

This study aims to explore the spillover effects of data breaches from a consumer perspective in the e-commerce context. Specifically, we investigate how an online retailer’s data…

Selling by contributing: the monetization strategy of individual content providers in the light of human brand

The integration of social media and e-commerce has resulted in a rising phenomenon among individual content providers (ICPs), who used to offer free content, to provide consumers…

Fostering the digital mindset to mitigate technostress: an empirical study of empowering individuals for using digital technologies

Technostress reduces employees' work performance and increases their turnover intentions, such that technostress harms organizations' success. This paper investigates how the…

The role of para-social relationship in live streaming virtual gift purchase: a two-stage SEM-neural network analysis

Despite the burgeoning popularity of virtual gifting in live streaming, research lacks an in-depth understanding of the drivers behind this behavior. Using para-social…

How review content, sentiment and helpfulness votes jointly affect trust of reviews and attitude

We investigate the joint impacts of three trust cues – content, sentiment and helpfulness votes – of online product reviews on the trust of reviews and attitude toward the…

Service quality in cloud gaming: instrument development and validation

The global market for cloud gaming is growing rapidly. How gamers evaluate the service quality of this emerging form of cloud service has become a critical issue for both…

How tie strength influences purchasing intention in social recommendation: evidence from behavioral model and brain activity

Social recommendation has been recognized as a kind of e-commerce with large potential, but how social recommendations influence consumer decisions is still unclear. This paper…

Generativity of enterprise IT infrastructure for digital innovation

Digital innovation requires organizations to reconfigure their information technology infrastructure (ITI) to cultivate creativity and implement fast experimentation. This…

Building bonds: an examination of relational bonding in continuous content contribution behaviors on metaverse-based non-fungible token platforms

The proliferation of non-fungible token (NFT)-based crypto-art platforms has transformed how creators manage, own and earn money through the creation, assets and identity of their…

A meta-analysis of antecedents and consequences of trust in the sharing economy

Trust plays a crucial role in overcoming uncertainty and reducing risks. Uncovering the trust mechanism in the sharing economy may enable sharing platforms to design more…

Effect of consistency of the review set on causal attribution: the moderating roles of repeating purchase cues and product knowledge

The study examines the potential moderating effects of repeating purchase cues and product knowledge on the relationship between the varying consistency of the review set and…

Longitudinal relationship between parental and adolescent smartphone addiction: serial mediating effects of adolescent self-esteem and depression

This study longitudinally investigated the predictors and mediators of adolescent smartphone addiction by examining the impact of parental smartphone addiction at T1 on adolescent…

Understanding users' voice assistant exploration intention: unraveling the differential mechanisms of the multiple dimensions of perceived intelligence

The purpose of this study is to develop a framework for the perceived intelligence of VAs and explore the mechanisms of different dimensions of the perceived intelligence of VAs…

Moment or movement – the heterogeneous impact of the Black Lives Matter movement on personal and societal charitable crowdfunding campaigns

Whenever social injustice tackled by social movements receives heightened media attention, charitable crowdfunding platforms offer an opportunity to proactively advocate for…

Consumer vulnerability: understanding transparency and control in the online environment

In the online environment, consumers increasingly feel vulnerable due to firms’ expanding capabilities of collecting and using their data in an unsanctioned manner. Drawing from…

How does social media use in the workplace affect employee voice? Uncovering the mediation effects of social identity and contingency role of job-social media fit

Employee voice is crucial for organizations to identify problems and make timely adjustments. However, promoting voice in organizations is challenging. This study aims to…

Gaining customer engagement in social media recovery: the moderating roles of timeliness and personalization

This research investigates the role of customer forgiveness as the result of online service recovery transparency in predicting customer engagement. It also examines the…

Factors influencing TikTok-based user purchase intention: comparison between potential customers and repeat customers

The purpose of this paper is to examine how different types of user experience in TikTok impact purchase intention via commitment to the influencer and commitment to the platform…

What enhances or worsens the user-generated metaverse experience? An application of BERTopic to Roblox user eWOM

Given its growing economic potential and social impact, this study aims to understand the motivations and concerns regarding metaverse usage. It identifies user needs and risks…

How social media fatigue feigning and altering emotion discourage the use of social media

Social media fatigue (SMF) has been widely recognized; however, previous studies have included various concepts into a single fatigue construct. Fatigue has typically been…

Motivation for writing long online reviews: a big data analysis of an anime community

Based on self-determination theory (SDT), this study aims to determine the motivation factors of reviewers writing long reviews in the anime industry.

A dual-process model to explain self-disclosure on online social networking sites: examining the moderating effect of enjoyment

Researchers continue to address the concept of self-disclosure because it is foundational for helping social networking sites (SNS) function and thrive. Nevertheless, the authors'…

Motivational profile and knowledge creation in eSports: examining the roles of mutualistic co-presence

Research on knowledge creation within eSports learning is scarce. This study extends the understanding of competition-oriented collaborative learning in eSports by examining the…

Performance implications of match between social media–enabled interactions and contracts in interfirm governance

Integrating transaction costs economics and task-technology fit theory, this study distinguishes two categories of social media–enabled interactions, namely task-related…

Herd behavior in social commerce: understanding the interplay between self-awareness and environment-awareness

This study investigates how individuals' self-awareness (specifically, private and public self-awareness) and environment-awareness (perceived expertise, similarity and…

Social media as a living laboratory for researchers: the relationship between linguistics and online user responses

Today, individuals use social media to express their opinions and feelings, which offers a living laboratory to researchers in various fields, such as management, innovation…

A mixed-methods investigation of the factors affecting the use of facial recognition as a threatening AI application

Artificial intelligence (AI) applications pose a potential threat to users' data security and privacy due to their high data-dependence nature. This paper aims to investigate an…

Wealth effects of firm's strategic technology investments: evidence from Ethereum blockchain

Ethereum-based blockchain technology (EBT) affords members of the Enterprise Ethereum Alliance (EEA) a market advantage in deploying blockchain within their organizations…

Effect of the fit between situational regulatory focus and feedback focus on customers' co-design behavior

Customers' co-design behavior is an important source of knowledge for product innovation. Firms can regulate the focus of information interaction with customers to set goals and…

Using machine learning to investigate consumers' emotions: the spillover effect of AI defeating people on consumers' attitudes toward AI companies

The purpose of this study is to investigate consumers' emotional responses to artificial intelligence (AI) defeating people. Meanwhile, the authors investigate the negative…

Fake news detection using machine learning: an adversarial collaboration approach

Purveyors of fake news perpetuate information that can harm society, including businesses. Social media's reach quickly amplifies distortions of fake news. Research has not yet…

Why retail firms commonly get only halfway through channel integration with online channels

This paper aims to examine why retail firms seldom achieve full integration of online and offline channels as prescribed in omni-channel literature. It examines the intermediate…

The effect of social commerce attributes on customer engagement: an empirical investigation

Social commerce (s-commerce) offers community-based platforms that facilitate customer-to-customer interactions and the development of customers' social shopping-based experience…

Value creation for online collaboration between doctors and medical institutions: empirical evidence from online health communities

Doctor–medical institution collaboration (DMIC) services are an emerging service mode in focal online health communities (OHCs). This new service mode is anticipated to affect…

Enterprise social media usage and social cyberloafing: an empirical investigation using the JD-R model

One of the most important challenges confronting enterprise managers is that of controlling employees' social cyberloafing. The use of enterprise social media entails…

Reexamining review variance and movie sales: the inverted-U-shaped relationship and boundary conditions

This study is based on the heuristic-systematic model (HSM) to dynamically examine the effect of review variance on sales and the boundary conditions that mitigate this effect.

The impact of streamer emotions on viewer gifting behavior: evidence from entertainment live streaming

The boom in live streaming has intensified competition among streamers for viewers' gifts, which makes it meaningful to study the factors that affect the viewers’ gifting…

Learning for success: understanding crowdfunding relaunch performance after initial failures

Fierce competition in the crowdfunding market has resulted in high failure rates. Owing to their dedication and efforts, many founders have relaunched failed campaigns as a…

Tap here to power up! Mobile augmented reality for consumer empowerment

The present study aims to propose a framework elucidating the attributes of mobile augmented reality (AR) shopping apps (i.e., spatial presence, perceived personalization and…

Short video marketing: what, when and how short-branded videos facilitate consumer engagement

This study explores whether and how four main factors of short-branded video content (content matching, information relevance, storytelling and emotionality) facilitate consumer…

IT investment and corporate collaborative innovation: the moderating role of the top management team's educational background and absorptive capacity

Previous studies have shown that the application of information technology (IT) can help break through the innovation boundaries of firms and has undoubtedly become a key enabler…

How intergroup counter-empathy drives media consumption and engagement

Social media is replete with malicious and unempathetic rhetoric yet few studies explain why these emotions are publicly dispersed. The purpose of the study is to investigate how…

It pays to be forthcoming: timing of data breach announcement, trust violation, and trust restoration

This research examines the relationship between the timeliness in announcing the discovery of a data breach and consumer trust in an e-commerce company, as well as later…

Disentangling the relationship between omnichannel integration and customer trust: a response surface analysis

This study aims to examine whether customer trust is influenced by the congruence and incongruence between customers' perceptions of two types of omnichannel integration—perceived…

Wear in or wear out: how consumers respond to repetitive influencer marketing

Endorsement marketing has been widely used to generate consumer attention, interest and purchase decisions among targeted audiences. Internet celebrities who become famous on the…

The coping strategies in fitness apps: a three-stage analysis with findings from SEM and FsQCA

Combining the coping theory and social support theory, this study aims to reveal users' coping strategies for mobile fitness app (MFA) engagement and fitness intentions with a…

Organizational mission and digital platform evolution: an investigation of entrepreneurial organizations in nascent markets

Although digital platforms have become important to organizations and society, little is known about how platforms evolve over time. This is particularly true for early-stage…

Loyalty and well-being explain serial crowdfunding backing behavior: an empirical test of complementary theories

Despite the critical contribution of serial backers in advancing crowdfunding volumes, few studies have addressed the phenomenon of serial backing. Research on the motivations of…

Revisiting the social commerce paradigm: the social commerce (SC) framework and a research agenda

Social commerce (SC) is a new genre in electronic commerce (e-commerce) that has great potential. This study proposes a new research framework to address deficiencies in existing…

Determinants of debunking information sharing behaviour in social media users: perspective of persuasive cues

Sharing and disseminating debunking information are critical to correcting rumours and controlling disease when dealing with public health crises. This study investigates the…

Fighting fire with fire: the use of an auxiliary platform to address the inherent weaknesses of a platform-based business

The success of sharing economy (SE) platforms has made it attractive for many firms to adopt this business model. However, the inherent weaknesses of these platforms, such as…

Developing future managers through business simulation gaming in the UK and Hong Kong: exploring the interplay between cognitive realism, decision-making and performance

This paper investigates how individuals' decision-making approach and perceptions of a game's cognitive realism affect the performance of virtual businesses in a web-based…

The role of vicarious learning strategies in shaping consumers' uncertainty: the case of live-streaming shopping

This article seeks to understand how live-streaming technology (i.e. interactivity and effective use of live-streaming shopping’s information presentation tool) impacts consumers’…

The influence of virtual reality on the experience of religious cultural heritage content

The purpose of this study is to expand the experience economy model and to determine if this model provides a better understanding of the process of growing intention to continue…

Competitive peer influence on knowledge contribution behaviors in online Q&A communities: a social comparison perspective

Users' knowledge contribution behaviors are critical for online Q&A communities to thrive. Well-organized question threads in online Q&A communities enable users to clearly read…

Friend-connecting affordances: playing online games to contact friends

Online games are popular applications of Internet technology, with over 2.8 billion users worldwide. Many players engage in team gameplay, indicating that online games are…

Bringing safety analytics to the online shopper: evaluating designs for augmenting point-of-sale interfaces with safety information

The widespread adoption of online purchasing has prompted increasing concerns about product safety, and regulators are beginning to hold e-commerce sites accountable for dangerous…

Small businesses and e-government participation: the role of personalisation preference and intermediaries

Advances in technology have given rise to an increased demand by small businesses for personalised e-government services. Given the importance of small businesses to the…

Leading for employees' enterprise system ambidextrous use through contextual ambidexterity: the mediating role of user empowerment and moderating role of leader–member exchange

This study aims to develop a cross-level research model to explore the relationship between team-level contextual ambidexterity and employees' enterprise system (ES) ambidextrous…

More than two decades of research on IoT in agriculture: a systematic literature review

Agriculture is one sector where the Internet of things (IoT) is expected to make a major impact. Yet, its adoption in the sector falls behind expectations. The purpose of this…

How does material adaptivity of smart objects shape infusion use? The pivot role of social embeddedness

Advances in material agency driven by artificial intelligence (AI) have facilitated breakthroughs in material adaptivity enabling smart objects to autonomously provide…

The effect of the motion attributes of spokes-characters on app launch pages on brand memory

The use of brand slogans that represent brand concepts on app launch pages can improve user brand impressions. The purpose of this paper is to investigate the impact of using…

The impacts of within-task and between-task personal Internet usage on employee creative performance: the moderating role of perceived organisational support

Employees' personal Internet usage (PIU) has become increasingly common at work. It is important for both researchers and managers to understand how PIU affects employee creative…

Understanding the role of information transparency in improving patient experience under different uncertainties: a quasi-natural experiment

Waiting time, as an important predictor of queue abandonment and patient satisfaction, is important for resource utilization and patient experience management. Medical…

Effects of member similarity on group norm conformity, group identity and social participation in the context of social networking sites

Facilitating members' continual participation in a community is crucial for ensuring the community's long-term survival. However, knowledge regarding whether member similarity is…

An empirical examination of newcomer contribution costs in established OSS communities: a knowledge-based perspective

To remain sustainable, open source software (OSS) projects must attract new members—or newcomers—who make contributions. In this paper, the authors develop a set of hypotheses…

Examining user-generated content, service failure recovery and customer–brand relationships: an exploration through commitment-trust theory

User-generated content (UGC) and service failure have attracted considerable marketing inquiry over the last two decades. Previous studies primarily focused on the outcome of…

Parasocial relationships with micro-influencers: do sponsorship disclosure and electronic word-of-mouth disrupt?

This study aims to examine whether and how the effect of intimate relationships with micro-influencers on customer behaviour is interrupted by external cues such as sponsorship…

An investigation on the influencing factors of elderly people's intention to use financial AI customer service

With the great changes brought by information technology, there is also a challenge for the elderly's acceptance. This study aimed to determine the antecedents of elderly people's…

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• 07 Nov 2023
• Cold Call Podcast

How Should Meta Be Governed for the Good of Society?

Julie Owono is executive director of Internet Sans Frontières and a member of the Oversight Board, an outside entity with the authority to make binding decisions on tricky moderation questions for Meta’s companies, including Facebook and Instagram. Harvard Business School visiting professor Jesse Shapiro and Owono break down how the Board governs Meta’s social and political power to ensure that it’s used responsibly, and discuss the Board’s impact, as an alternative to government regulation, in the case, “Independent Governance of Meta’s Social Spaces: The Oversight Board.”

• 29 Aug 2023

As Social Networks Get More Competitive, Which Ones Will Survive?

In early 2023, TikTok reached close to 1 billion users globally, placing it fourth behind the leading social networks: Facebook, YouTube, and Instagram. Meanwhile, competition in the market for videos had intensified. Can all four networks continue to attract audiences and creators? Felix Oberholzer-Gee discusses competition and imitation among social networks in his case “Hey, Insta & YouTube, Are You Watching TikTok?”

• 15 Aug 2023

(Virtual) Reality Check: How Long Before We Live in the 'Metaverse'?

Generative AI has captured the collective imagination for the moment, eclipsing the once-hyped metaverse. However, it's not the end of virtual reality. A case study by Andy Wu and David Yoffie lays out the key challenges immersive 3D technology must overcome to be truly transformative.

• 15 Nov 2022

Why TikTok Is Beating YouTube for Eyeball Time (It’s Not Just the Dance Videos)

Quirky amateur video clips might draw people to TikTok, but its algorithm keeps them watching. John Deighton and Leora Kornfeld explore the factors that helped propel TikTok ahead of established social platforms, and where it might go next.

• 22 Aug 2022
• Research & Ideas

Can Amazon Remake Health Care?

Amazon has disrupted everything from grocery shopping to cloud computing, but can it transform health care with its One Medical acquisition? Amitabh Chandra discusses company's track record in health care and the challenges it might face.

• 06 Jan 2021
• Working Paper Summaries

Aggregate Advertising Expenditure in the US Economy: What's Up? Is It Real?

We analyze total United States advertising spending from 1960 to 2018. In nominal terms, the elasticity of annual advertising outlays with respect to gross domestic product appears to have increased substantially beginning in the late 1990s, roughly coinciding with the dramatic growth of internet-based advertising.

• 21 Jan 2020

The Impact of the General Data Protection Regulation on Internet Interconnection

While many countries consider implementing their own versions of privacy and data protection regulations, there are concerns about whether such regulations may negatively impact the growth of the internet and reduce technology firms’ incentives in operating and innovating. Results of this study suggest limited effects of such regulations on the internet layer.

• 18 Jul 2019
• Lessons from the Classroom

The Internet of Things Needs a Business Model. Here It Is

Companies have struggled to find the right opportunities for selling the Internet of Things. Rajiv Lal says that’s all about to change. Open for comment; 0 Comments.

• 04 Mar 2019
• What Do You Think?

What’s the Antidote to Surveillance Capitalism?

SUMMING UP: As companies increasingly build business models around our personal data, what can be done to fight back? James Heskett's readers suggest there are no easy answers. Open for comment; 0 Comments.

• 30 May 2018

Should Retailers Match Their Own Prices Online and in Stores?

For multichannel retailers, pricing strategy can be difficult to execute and confusing to shoppers. Research by Elie Ofek and colleagues offers alternative approaches to getting the price right. Open for comment; 0 Comments.

• 24 May 2018

Distance Still Matters in Business, Despite the Internet

The internet makes distance less a problem for conducting business, but geography still matters in the digital age. Shane Greenstein explains why. Open for comment; 0 Comments.

• 12 Mar 2018

Using Online Prices for Measuring Real Consumption Across Countries

The increasing availability of big data can improve measurement of real consumption in closer to real time. This study shows that online prices may enhance data of the International Comparisons Program, dramatically improving the frequency and transparency of purchasing power parities compared with traditional data collection methods.

• 02 Mar 2018

Evidence of Decreasing Internet Entropy: The Lack of Redundancy in DNS Resolution by Major Websites and Services

Stabilizing the domain name resolution (DNS) infrastructure is critical to the operation of the internet. Single points of failure become more consequential as a larger proportion of the internet's biggest sites are managed by a small number of externally hosted DNS providers. Providers could encourage diversification by requiring domain owners to select a secondary DNS provider.

• 16 Nov 2016

Turning One Thousand Customers into One Million

In the second part of a series on growing startups, Thales S. Teixeira explains how Uber, Etsy, and Airbnb climbed from one thousand customers to one million. Open for comment; 0 Comments.

• 19 Oct 2016

Three Critical Mistakes Digital Businesses Make With Content

Do companies really understand the nature of today's digital transformation? Bharat Anand's book The Content Trap offers a new view of digital strategy that shifts the focus from "produce the best content" to "create the best connections." Open for comment; 0 Comments.

• 14 Sep 2016

Web Surfers Have a Schedule and Stick to It

Note to web marketers: Consumers won't carve out more time to visit your site. So how do you attract them? Start by understanding their online habits, reports new research by Shane Greenstein and colleagues. Open for comment; 0 Comments.

• 17 Aug 2016

The Empirical Economics of Online Attention

This study uses extensive data on user online activity between 2008 and 2013 to examine the links between user allocation of attention and characteristics of user. Findings show remarkable stability in how households allocated their scarce attention over the five years. Results imply that suppliers are competing for a finite supply of user time while generally lacking the ability to use price discounts to attract user attention.

• 15 Aug 2016

Black Swans and Big Trends Can Ruin Anyone's Internet Prediction

Coming off the dot-com bust, Thomas R. Eisenmann was confident enough in his internet vision that he wrote a book about what would happen next. For the most part, he was wrong. He offers lessons learned for navigating the boom-bust cycle. Open for comment; 0 Comments.

• 04 May 2016

What Does Boaty McBoatface Tell Us About Brand Control on the Internet?

SUMMING UP. Boaty McBoatface may have been shot down as the social-media sourced name of a research vessel, but James Heskett's readers are up to their hip-boots in opinions on the matter. Open for comment; 0 Comments.

• 07 Mar 2016

Net Neutrality: A Fast Lane to Understanding the Trade-offs

Shane Greenstein and colleagues identify the economic dimensions involved with net neutrality and show that many questions can be informed by simple economic models of the market for internet services.

Read our research on: Gun Policy | International Conflict | Election 2024

Regions & Countries

How the political typology groups compare.

Pew Research Center’s political typology sorts Americans into cohesive, like-minded groups based on their values, beliefs, and views about politics and the political system. Use this tool to compare the groups on some key topics and their demographics.

Some digital divides persist between rural, urban and suburban America

Rural adults are less likely than suburban adults to have home broadband and less likely than urban adults to own a smartphone, tablet or computer.

Home broadband adoption, computer ownership vary by race, ethnicity in the U.S.

Black and Hispanic Americans remain less likely than White adults to say they own a traditional computer or have high-speed internet at home.

Mobile Technology and Home Broadband 2021

Smartphone ownership and home broadband adoption are up slightly since 2019. And 30% of Americans say they at least sometimes experience problems connecting to the internet at home.

34% of lower-income home broadband users have had trouble paying for their service amid COVID-19

Some 15% of all home broadband users in the U.S. say they have had trouble paying for their high-speed internet service during the pandemic.

Mobile Technology and Home Broadband 2019

Note: For the latest survey data on home broadband adoption and smartphone use, see “Mobile Technology and Home Broadband 2021” As the share of Americans who say they own a smartphone has increased dramatically over the past decade – from 35% in 2011 to 81% in 2019 – a new Pew Research Center survey finds that […]

Internet, social media use and device ownership in U.S. have plateaued after years of growth

The use of digital technology has had a long stretch of rapid growth in the United States, but the share of Americans who go online, use social media or own key devices has remained stable the past two years.

About a quarter of rural Americans say access to high-speed internet is a major problem

Fast, reliable internet service has become broadly essential. But 24% of rural U.S. adults say access to high-speed internet is a major problem in their community.

Declining Majority of Online Adults Say the Internet Has Been Good for Society

At the same time, the contours of connectivity are shifting: One-in-five Americans (20%) are now ‘smartphone only’ internet users at home.

Facts on Foreign Students in the U.S.

The U.S. has more foreign students enrolled in its colleges and universities than any other country in the world. Explore data about foreign students in the U.S. higher education system.

Refine Your Results

About Pew Research Center Pew Research Center is a nonpartisan fact tank that informs the public about the issues, attitudes and trends shaping the world. It conducts public opinion polling, demographic research, media content analysis and other empirical social science research. Pew Research Center does not take policy positions. It is a subsidiary of The Pew Charitable Trusts .

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Research: How is the digital divide evolving in 2024?

From revealing the current state of connectivity in homes to exploring the potential of bridging the digital divide, this new research from Amdocs unveils challenges, opportunities, and more.

Michael Zema

Corporate Communications

11 Apr 2024

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According to The Changing Divide Report 2024, most American consumers (91%) now have dependable internet access. 

Nevertheless, as our homes become more interconnected and technology like GenAI changes our world, new obstacles are emerging that jeopardize the progress made - and may deepen the digital divide.

Conducted by Dynata, Amdocs surveyed 1,000 US consumers to look at the current state of the digital divide and connected homes, and here’s what we found:

Consumers are clear about the importance of connectivity

Connected devices in the home continue to increase exponentially

• 39% of consumers have more than 6 connected devices in their home. Notably, 17% of low-income households have nine or more devices – up from 13% last year.

“With the pace of change continuing to accelerate around us, ubiquitous connectivity has truly become a non-negotiable. We’ve long acknowledged the impact that the digital divide has on underserved populations, but with profound technology changes like Generative AI democratizing access to data and changing the way we do business and live our lives, it has never been more important to focus on addressing that gap. In fact, because of this rapid technology change, individuals at the lower end of the socioeconomic ladder actually stand to benefit even more disproportionately from connectivity than ever before, and that makes our role as global connectivity players and enablers even more essential."

Anthony Goonetilleke

Group President of Technology and Head of Strategy at Amdocs

AI is considered a double-edged sword

• 77% of Americans are concerned about the rise of AI and AI-infused experiences increasing the digital divide.
• 27% of respondents said that businesses building more AI-infused experiences need to better prioritize how they address the digital divide.

Leading into the 2024 presidential election, the digital divide is a top interest

• Nearly three-quarters (71%) of Americans say they believe it is important to consider closing the digital divide and improving the internet for all, an increase of 10% over 2023. This was nearly consistent across all generations – Baby Boomers (69%), Gen X (69%), Millennials (78%), and Gen Z (70%).

When asked who should be responsible for providing communities with reliable internet, most agree that it is some level of government.

• Respondents pointed to the federal government – including Congress (11%), state government (11%), and local government (10%) – followed by an additional 11% saying all levels of government have a role to play. Just 20% say it’s up to businesses.

Related insights

Tackling the Digital Divide

While the advent of tech innovation enables new experiences & new waves of connectivity, addressing the digital divide must become a priority to ensure everyone has equal access to the digital future

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World-first “Cybercrime Index” ranks countries by cybercrime threat level

Following three years of intensive research, an international team of researchers have compiled the first ever ‘World Cybercrime Index’, which identifies the globe’s key cybercrime hotspots by ranking the most significant sources of cybercrime at a national level.

The Index, published today in the journal PLOS ONE , shows that a relatively small number of countries house the greatest cybercriminal threat. Russia tops the list, followed by Ukraine, China, the USA, Nigeria, and Romania. The UK comes in at number eight.

‘The research that underpins the Index will help remove the veil of anonymity around cybercriminal offenders, and we hope that it will aid the fight against the growing threat of profit-driven cybercrime,’ Dr Bruce said.

‘We now have a deeper understanding of the geography of cybercrime, and how different countries specialise in different types of cybercrime.’

‘By continuing to collect this data, we’ll be able to monitor the emergence of any new hotspots and it is possible early interventions could be made in at-risk countries before a serious cybercrime problem even develops.’

The data that underpins the Index was gathered through a survey of 92 leading cybercrime experts from around the world who are involved in cybercrime intelligence gathering and investigations. The survey asked the experts to consider five major categories of cybercrime*, nominate the countries that they consider to be the most significant sources of each of these types of cybercrime, and then rank each country according to the impact, professionalism, and technical skill of its cybercriminals.

Co-author Associate Professor Jonathan Lusthaus , from the University of Oxford’s Department of Sociology and Oxford School of Global and Area Studies, said cybercrime has largely been an invisible phenomenon because offenders often mask their physical locations by hiding behind fake profiles and technical protections.

'Due to the illicit and anonymous nature of their activities, cybercriminals cannot be easily accessed or reliably surveyed. They are actively hiding. If you try to use technical data to map their location, you will also fail, as cybercriminals bounce their attacks around internet infrastructure across the world. The best means we have to draw a picture of where these offenders are actually located is to survey those whose job it is to track these people,' Dr Lusthaus said.

Figuring out why some countries are cybercrime hotspots, and others aren't, is the next stage of the research. There are existing theories about why some countries have become hubs of cybercriminal activity - for example, that a technically skilled workforce with few employment opportunities may turn to illicit activity to make ends meet - which we'll be able to test against our global data set. Dr Miranda Bruce  Department of Sociology, University of Oxford and UNSW Canberra   

Co-author of the study, Professor Federico Varese from Sciences Po in France, said the World Cybercrime Index is the first step in a broader aim to understand the local dimensions of cybercrime production across the world.

‘We are hoping to expand the study so that we can determine whether national characteristics like educational attainment, internet penetration, GDP, or levels of corruption are associated with cybercrime. Many people think that cybercrime is global and fluid, but this study supports the view that, much like forms of organised crime, it is embedded within particular contexts,’ Professor Varese said.

The World Cybercrime Index has been developed as a joint partnership between the University of Oxford and UNSW and has also been funded by CRIMGOV , a European Union-supported project based at the University of Oxford and Sciences Po. The other co-authors of the study include Professor Ridhi Kashyap from the University of Oxford and Professor Nigel Phair from Monash University.

The study ‘Mapping the global geography of cybercrime with the World Cybercrime Index’ has been published in the journal PLOS ONE .

*The five major categories of cybercrime assessed by the study were:

1.   Technical products/services (e.g. malware coding, botnet access, access to compromised systems, tool production).

2.   Attacks and extortion (e.g. denial-of-service attacks, ransomware).

3.   Data/identity theft (e.g. hacking, phishing, account compromises, credit card comprises).

4.   Scams (e.g. advance fee fraud, business email compromise, online auction fraud).

5.   Cashing out/money laundering (e.g. credit card fraud, money mules, illicit virtual currency platforms).

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This paper is in the following e-collection/theme issue:

Published on 11.4.2024 in Vol 26 (2024)

This is a member publication of Imperial College London (Jisc)

Regulatory Standards and Guidance for the Use of Health Apps for Self-Management in Sub-Saharan Africa: Scoping Review

Authors of this article:

• Benard Ayaka Bene 1, 2 , MBBS, MPH   ; 
• Sunny Ibeneme 3 , MD, PhD   ; 
• Kayode Philip Fadahunsi 1 , MBBS, MPH   ; 
• Bala Isa Harri 4 , MBBS, MPH, MSc   ; 
• Nkiruka Ukor 5 , MSc   ; 
• Nikolaos Mastellos 1 , BSc, PhD   ; 
• Azeem Majeed 1 , MD   ; 
• Josip Car 1, 6 , MSc, MD, PhD  

1 Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, United Kingdom

2 Department of Public Health, Federal Ministry of Health, Abuja, Nigeria

3 Digital Health Specialist, UNICEF East Asia Pacific Regional Office, Bangkok, Thailand

4 Department of Health Planning, Research and Statistics, Federal Ministry of Health, Abuja, Nigeria

5 Strategic Health Information Cluster, World Health Organization, Abuja, Nigeria

6 School of Life Course & Population Sciences, King’s College London, London, United Kingdom

Corresponding Author:

Benard Ayaka Bene, MBBS, MPH

Department of Primary Care and Public Health

School of Public Health

Imperial College London

The Reynolds Building

St Dunstan’s Road

London, W6 8RP

United Kingdom

Phone: 44 7598439185

Email: [email protected]

Background: Health apps are increasingly recognized as crucial tools for enhancing health care delivery. Many countries, particularly those in sub-Saharan Africa, can substantially benefit from using health apps to support self-management and thus help to achieve universal health coverage and the third sustainable development goal. However, most health apps published in app stores are of unknown or poor quality, which poses a risk to patient safety. Regulatory standards and guidance can help address this risk and promote patient safety.

Objective: This review aims to assess the regulatory standards and guidance for health apps supporting evidence-based best practices in sub-Saharan Africa with a focus on self-management.

Methods: A methodological framework for scoping reviews was applied. A search strategy was built and applied across the following databases, gray literature sources, and institutional websites: PubMed, Scopus, World Health Organization (WHO) African Index Medicus, OpenGrey, WHO Regional Office for Africa Library, ICTworks, WHO Directory of eHealth policies, HIS Strengthening Resource Center, International Telecommunication Union, Ministry of Health websites, and Google. The search covered the period between January 2005 and January 2024. The findings were analyzed using a deductive descriptive content analysis. The policy analysis framework was adapted and used to organize the findings. The Reporting Items for Stakeholder Analysis tool guided the identification and mapping of key stakeholders based on their roles in regulating health apps for self-management.

Results: The study included 49 documents from 31 sub-Saharan African countries. While all the documents were relevant for stakeholder identification and mapping, only 3 regulatory standards and guidance contained relevant information on regulation of health apps. These standards and guidance primarily aimed to build mutual trust; promote integration, inclusion, and equitable access to services; and address implementation issues and poor coordination. They provided guidance on systems quality, software acquisition and maintenance, security measures, data exchange, interoperability and integration, involvement of relevant stakeholders, and equitable access to services. To enhance implementation, the standards highlight that legal authority, coordination of activities, building capacity, and monitoring and evaluation are required. A number of stakeholders, including governments, regulatory bodies, funders, intergovernmental and nongovernmental organizations, academia, and the health care community, were identified to play key roles in regulating health apps.

Conclusions: Health apps have huge potential to support self-management in sub-Saharan Africa, but the lack of regulatory standards and guidance constitutes a major barrier. Hence, for these apps to be safely and effectively integrated into health care, more attention should be given to regulation. Learning from countries with effective regulations can help sub-Saharan Africa build a more robust and responsive regulatory system, ensuring the safe and beneficial use of health apps across the region.

International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2018-025714

Introduction

Health apps are the most widely used digital health products globally [ 1 , 2 ]. Harnessing the potential of health apps creates a huge opportunity in providing support for health care delivery, including patient communication, patient education, and decision support for self-management [ 3 - 8 ]. Health apps can be an effective tool to strengthen health systems worldwide, especially in low- and middle-income countries including those in sub-Saharan Africa [ 4 , 5 , 9 ]. As a result, the attainment of universal health coverage (UHC) and sustainable development goal (SDG) 3, good health and well-being, can be accelerated [ 8 , 10 ].

Many health apps fall below the expected quality threshold [ 11 ]. Several studies have found that widely used health apps are often technically unreliable and clinically unsafe [ 12 - 14 ] and do not comply with ethical standards and the principles of confidentiality of information and data privacy [ 15 , 16 ]. In addition, many commercially available health apps were not developed using interoperability standards that are widely accepted in sub-Saharan Africa (eg, Fast Healthcare Interoperability Resources [FHIR]) [ 17 - 20 ]. Consequently, it becomes difficult to integrate these apps into a clinical workflow.

Hence, regulation through robust mechanisms is crucial to enhance the development, implementation, and adoption of health apps. Regulatory standards and guidance are essential for the safety of patients as they ensure quality assurance of any new technology in health care and contribute to building mutual trust while promoting the optimal use of the technology [ 21 - 23 ]. Therefore, to ensure that health apps that are used to support the self-management of patients are technically reliable and clinically safe, interoperable across systems, and compliant with the principles of confidentiality of information and data privacy, there is a need for effective regulatory standards. Furthermore, effective regulation can help ensure that health apps for self-management are culturally functional and competent and are accessible to those who need them regardless of gender, ethnicity, geographical location, or financial status [ 24 - 31 ].

Since 2005, there have been ongoing efforts to strengthen digital health governance at both the national and international levels [ 32 , 33 ]. In 2018, the World Health Organization (WHO) member states renewed their commitment to using digital health technologies (DHTs) to advance UHC and SDG 3 [ 33 ]. However, to date, the extent to which the use of health apps for self-management is regulated across countries within the WHO African Region (also known as sub-Saharan Africa) remains unclear. Therefore, this review was conducted to identify available regulatory standards and guidance and assess the extent to which they regulate health apps for self-management in sub-Saharan Africa. The review also mapped out the key stakeholders and their roles in regulating health apps for self-management across sub-Saharan Africa.

Review Questions

The review attempted to answer the following questions: (1) What regulatory standards and guidance are available for regulating health apps for self-management across sub-Saharan Africa? (2) To what extent do regulatory standards and guidance regulate health apps for self-management in terms of what aspects are regulated; why, how, and for whom; and what aspects are not regulated? (3) Who are the key stakeholders and what are their roles in regulating health apps for self-management?

Study Design

The process of this scoping review followed the methodological framework for conducting a scoping study originally described by Arksey and O’Malley [ 34 ] and the updated methodological guidance for conducting a Joanna Briggs Institute scoping review [ 34 - 37 ]. The reporting of the review was guided by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist [ 38 ]. A completed PRISMA-ScR checklist is provided in Multimedia Appendix 1 . The protocol of this scoping review was published in BMJ Open [ 30 ].

Identifying Relevant Documents

Two reviewers (BAB and SI) developed the search strategy with the assistance of a librarian and in consultation with other research team members (KPF, BIH, NU, NM, AM, and JC). The following key terms were included: policy, legislation, strategy, regulation, standard, criterion, framework, guidance, guideline, digital health, eHealth, app, WHO African Region, and sub-Saharan Africa, and the names of all sub-Saharan African countries.

Owing to the absence of regulatory standards and guidance in scientific databases, the search focus was narrowed down to gray literature sources and institutional websites, including OpenGrey, WHO Regional Office for Africa (AFRO) Library, repositories for digital health policies (ICTworks, WHO’s Directory of eHealth Policies, and Health Information System Strengthening Resource Center), as well as the websites of WHO, International Telecommunication Union (ITU), and Ministries of Health (MOHs). The only scientific databases searched were PubMed, Scopus, and WHO AIM. PubMed was not included in the protocol. We also conducted a systematic search on Google. We used truncation to increase the yield of the results. The search strategy was then applied across PubMed, Scopus, and WHO AIM databases using Boolean terms (mainly OR and AND ) to combine search results. Gray literature sources and institutional websites were searched using phrases containing ≥2 keywords such as “eHealth regulation,” “digital health regulatory standard,” “eHealth regulatory standard,” “digital health regulation,” “digital health policy,” “eHealth policy,” “digital health strategy,” and “eHealth strategy.” For Google search, we added the names of the country to the phrases (eg, “digital health regulation Nigeria”). The reference lists of the included documents were also searched, and key individuals at the MOHs, WHO Country Offices, and the WHO AFRO were contacted for related documents. When our search was conducted, the WHO Directory of eHealth policies website was unavailable, and the WHO AFRO Library was undergoing reconstruction. The search strategies for PubMed, Scopus, and WHO AIM are provided in Multimedia Appendix 2 . The search was conducted between 2005 and January 2024.

Study Selection

The search results obtained from PubMed, Scopus, and WHO AIM were imported into Mendeley (Elsevier) [ 39 ] to remove duplicates. The search conducted on OpenGrey did not yield any results, whereas relevant records obtained from institutional websites, repositories, and Google were downloaded as PDF copies and uploaded to Mendeley. After removing duplicates, the remaining results were imported into Covidence (Veritas Health Innovation) [ 40 ] for screening. Two reviewers (BAB and SI) applied the predefined eligibility criteria ( Textbox 1 ) to screen the documents in 2 stages (title and abstract or executive summary). All discrepancies were discussed until the reviewers reached agreement.

Inclusion criteria

• Type of document: Regulatory standards, guidance, policies, strategies, and committee or government reports that address regulatory issues related to the use of health apps for self-management
• Location: Documents developed and implemented in countries within sub-Saharan Africa
• Date of publication: Documents developed since 2005; the global efforts toward promoting standards to minimize variability and potential harms that could arise from poorly regulated use of digital health began in 2005 [ 33 ]
• Language: Documents written in English language and other official languages of sub-Saharan African countries (Portuguese and French)

Exclusion criteria

• Type of document: Standards, guidance, policies, strategies, and reports not related to regulation of health apps
• Location: Documents from countries outside sub-Saharan Africa
• Date of publication: Documents developed before 2005
• Language: None

Data Charting (Extraction)

Two reviewers (BAB and SI), in consultation with the other members of the research team, developed the data extraction forms using an iterative process that included piloting data extraction and refinement until a consensus was reached.

We proposed in the study protocol [ 30 ] that data extraction would be conducted by the 2 reviewers independently. However, owing to the approach adopted for data extraction (deductive qualitative content analysis), 1 reviewer, rather than 2, initially extracted data from the included documents, and any concerns were discussed with a second reviewer [ 41 ]. Unresolved issues were then discussed and resolved with a third reviewer in a steering group meeting.

Collating, Summarizing, and Reporting Results

To address the research questions (particularly question 2), we adopted a deductive descriptive qualitative content analysis method to analyze and report the key findings. The policy analysis framework by Walt and Gilson [ 42 ] was adapted and applied to ensure that there was a consistent way of organizing the key findings: (1) Content (which aspects are regulated and which aspects are not?)—these are the components that directly or indirectly address regulatory issues related to the use of health apps for self-management, including areas that have not been addressed. (2) Context (why are those aspects regulated?)—this characterizes the rationale indicated for addressing regulatory issues related to the use of health apps for self-management. (3) Process (how are the regulatory standards developed and implemented?)—this describes the methods or approaches used to develop and implement regulatory standards. (4) Actors (who are the regulatory standards targeted toward?)—these are the key actors targeted by the standards.

Using a deductive descriptive qualitative content analysis approach, we examined each included document to systematically identify texts for concepts, patterns, and other relevant information. We then categorized them under content, context, process, or actors in relation to regulating health apps for self-management. The findings under content and context were further organized based on 4 predefined regulatory categories or themes as documented in the literature, namely (1) technical and clinical safety [ 12 - 14 ], (2) data protection and security [ 15 , 16 ], (3) standards and interoperability [ 28 , 31 ], and (4) inclusion and equitable access [ 24 - 29 ].

To address the third research question, the Reporting Items for Stakeholder Analysis (RISA) tool [ 41 ] was used as a guide to group key stakeholders based on role categorization as recognized globally by the WHO, the ITU, and UNESCO [ 32 , 33 , 43 ].

Ethical Considerations

Primary data were not collected in this study. Therefore, no ethics approval was required.

Search Results

A total of 2900 records were obtained after removing duplicates. Although the literature search was conducted in English, the search also yielded documents written in French and Portuguese from the ICTworks repository [ 44 ]. Following the initial screening of the title and abstract (or executive summaries), 73 documents were retrieved for full-text assessment. After applying the inclusion criteria for the full-text assessment, 49 documents were found eligible for inclusion in the review.

The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram [ 45 ] showing the study selection process is presented in Figure 1 .

Types of Documents

On the basis of the inclusion criteria, 3 categories of documents were considered for this review, namely “stand-alone regulatory standards and guidance that potentially regulate health apps for self-management,” “national policies and strategies on digital health,” and “other national documents that relate to the regulation of health apps for self-management.” Table 1 presents the types of documents obtained for each country within sub-Saharan Africa.

Characteristics of the Included Documents

Stand-alone regulatory standards and guidance.

We identified and included 6 stand-alone regulatory standards [ 18 , 19 , 46 - 49 ] from 3 countries (Ethiopia, Kenya, and Nigeria). All 6 documents were written in English. The years of development ranged between 2013 and 2021, as indicated in Multimedia Appendix 3 . The years of implementation were not specifically stated.

Although none of the included regulatory standards were exclusively developed to regulate health apps for self-management, 3 of them (Kenya Standards and Guidelines for mHealth Systems [ 18 ], Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ], and Health Sector Information and Communications Technology Standards and Guidelines [ 48 ]) provided concept and information relevant to the regulation of health apps and were included in the qualitative content analysis. The Kenya Standards and Guidelines for mHealth Systems [ 18 ] provides standards and guidelines on the design, development, and implementation of mobile health (mHealth) solutions to ensure they are interoperable, scalable, and sustainable. The Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] outlines the principles, requirements, and standards for eHealth systems interoperability in Kenya. The Health Sector Information and Communications Technology Standards and Guidelines [ 48 ] provide guidance and a consistent approach across the health sector in Kenya for establishing, acquiring, and maintaining current and future information systems and information and communications technology (ICT) infrastructure that foster interoperability across systems. These 3 documents are a good combination of regulatory standards and guidance that provide content and context relevant to the regulation of health apps in sub-Saharan Africa.

The remaining 3 standards (standard for electronic health record [EHR] system in Ethiopia [ 19 ], standards and guidelines for electronic medical record systems in Kenya [ 46 ], and the health information exchange standard operating procedure and guideline [ 49 ]) were exclusively developed for EHRs or electronic medical records. However, they contain information relevant for mapping stakeholders with potential roles in regulating health apps for supporting self-management.

National Policies and Strategies on Digital Health

This review includes 35 national policies and strategies that are related to digital health (potentially covering health apps) [ 50 - 84 ] from 31 countries written in English, French, and Portuguese (Benin, Botswana, Burkina Faso, Burundi, Cameroon, Comoros, Côte d’Ivoire [Ivory Coast], Democratic Republic of the Congo, Eswatini, Ethiopia, Gabon, Ghana, Kenya, Liberia, Madagascar, Malawi, Mali, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, South Africa, Tanzania, Togo, Uganda, Zambia, and Zimbabwe). Although the literature search was conducted in English, it also yielded documents written in French and Portuguese from the ICTworks repository. The years of development and implementation range between 2005 and 2030. Policies and strategies written in French and Portuguese were translated into English using Google Translate. Documents labeled as national development plans, strategic plans, and strategic development plans were considered as national strategies.

National policies and strategies do not offer specific standards or guidance, but rather outline the country’s vision, policy directions, and strategies for using digital technologies in health care. They provide useful information for identifying digital health stakeholders who can play a role in regulating health apps for self-management. For example, Nigeria has a separate National Digital Health Policy [ 72 ] and a National Digital Health Strategy [ 71 ]. Both documents were developed by building on the lessons learned from the end-term evaluation of the previous National Health ICT Strategic Framework [ 85 ]. They describe Nigeria’s renewed vision, mission, goals, objectives, and strategies for the development and implementation of digital health with the aim to improve the quality, efficiency, and effectiveness of health service delivery and health outcomes.

It is worth noting that for countries with >1 policy or strategy, we included only the most recent versions. For instance, as mentioned earlier, Nigeria now has both a national digital health policy and a national digital health strategy. These 2 documents supersede and thus replace the old National Health ICT Strategic Framework [ 86 ]. Details of included documents are presented in Multimedia Appendix 3 .

Other Related National Documents

We included 8 other documents [ 20 , 85 , 87 - 92 ] from 6 countries (Ethiopia, Kenya, Liberia, Nigeria, South Africa, and Tanzania) that did not fall under either stand-alone regulatory standards and guidance or national policies and strategies. These were mostly frameworks, road maps, and reports that potentially provide information relevant to the use of health apps. The years of development and implementation range from 2016 to 2025. These documents do not provide standards or guidance, but they contain information that can help map the digital health stakeholders that potentially play a role in regulating health apps for self-management. When multiple versions of a document exist, only the latest version was taken into consideration. Multimedia Appendix 3 provides details of the included documents.

Content: Aspects That Are Regulated and Aspects That Are Not

Technical and clinical safety.

Technical and clinical safety standards are required to prevent or minimize the harm that may arise from the use of the health ICT systems (including mHealth systems) as well as to improve the health outcomes and user satisfaction. As shown in Figure 2 , two subthemes were generated from included standards [ 18 , 47 , 48 ] as content under technical and clinical safety: v(1) guidance on system quality and (2) guidance on software or app development, acquisition, support, and maintenance.

Notably, 2 of the included standards [ 18 , 47 ] provide guidance on system quality to ensure the quality, security, reliability, performance, and maintenance of eHealth and mHealth systems. The Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] recommend the implementation of a data quality protocol to ensure that the data collection, collation, analysis, interpretation, dissemination, and use are managed in accordance with the quality standards. Similarly, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] recommends the inclusion of the following requirements in the technical manual: (1) minimum hardware requirements that should incorporate the preferred hardware architecture, (2) minimum software requirements that should include the minimum version of the underlying operating system as well as acceptable versions of related software, and (3) a detailed list of software dependencies (external libraries) necessary for the system to function properly.

The included standards [ 18 , 48 ] cover guidance on software or app development, acquisition, support, and maintenance, which aim to ensure the efficiency and effectiveness of eHealth and mHealth systems. The Kenya Standards and Guidelines for mHealth Systems [ 18 ] recommends a technical manual to provide a detailed description of the system’s installation and maintenance processes for system administrators and implementers; a developer’s guide for software developers and programmers to provide them with an overview of the system, description of the software design methodologies, description of the system architecture, and technical design diagrams; and a user manual to aid users in understanding how the system works and how each feature operates; in addition, the technical manual contains instructions for operating the software; entering and updating data; and generating, saving, and printing reports.

Although the contents generated here provide guidance that is relevant to health apps, they are not specific to health apps. Moreover, there are no clear measures to enable individuals or organizations that use health apps to manage clinical risk appropriately.

Data Protection and Security

Data protection and security are crucial aspects of managing patient information, thus ensuring the confidentiality, integrity, and availability of data as well as the rights and interests of the patient. Two subthemes related to data protection and security are (1) security measures for adequate protection of patients’ digital records and (2) guidance on data exchange.

The included standards [ 18 , 48 ] provide security measures for eHealth or mHealth systems to ensure the adequate protection of digitally accessible patient records. These measures include authentication, accountability, identification, authorization, integrity, confidentiality, availability, security, administration, and audit. This will help to achieve confidentiality, integrity, availability, and nonrepudiation of patient data or health records. Additional levels of security such as data encryption are required when there is a need to store sensitive information on removable devices or media or outside the MOH premises.

The Kenya Standards and Guidelines for mHealth Systems [ 18 ] provide the following guidance on data exchange to ensure privacy: (1) anonymize client data as much as possible before they can be shared; (2) where possible, use pseudonyms for the client data before they can be shared; (3) aggregate client data before they can be shared to reduce possibilities of tracing the data back to the client; and (4) minimize data so that access is available only to the data set required for that particular use. With regard to privacy rules, the Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] propose that a notice of privacy practices should be given to patients describing how their information may be used or shared while also specifying their legal rights.

Standards and Interoperability

Standards and interoperability are essential concepts in the field of IT, especially for systems that need to communicate and exchange data, as seen in the use of health apps for self-management. Two subthemes related to standards and interoperability are (1) interoperability as a basic requirement and (2) minimum standards to enable integration.

All the regulatory standards [ 18 , 47 , 48 ] highlight the importance of having interoperability as a basic requirement when selecting software products or services for use within the health system. This facilitates interaction across systems. For instance, to facilitate seamless interaction between mHealth systems and primary information systems for data capture, reporting, and decision support in various domains of the health system, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] recommends the incorporation of at least 3 types of interoperability, namely, technical interoperability, semantic interoperability, and process interoperability.

Furthermore, 2 regulatory standards [ 18 , 47 ] proposed minimum interoperability standards to enable the integration of services and data exchange between various systems in health care. For instance, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] suggests standards (for interoperability) for mHealth systems that are consistent with the recommendations in internationally accepted standards. They include the following: (1) clinical messaging—ensuring mHealth systems conform to Health Level 7 (HL7) version 3 standards and corresponding implementation guideline; (2) clinical terminology—ensuring terminologies and classifications for clinical concepts (eg, International Classification of Diseases, tenth revision—for diseases; Systemized Nomenclature of Medicine—for clinical data coding; Logical Observation Identifiers Names and Codes—for laboratories; and RxNorm—for Pharmacies); (3) the mHealth system must use the latest versions of international standards, such as HL7 Clinical Document Architecture for electronic sharing of clinical documents; (4) concepts—mHealth systems will use the idea of “concepts” so that information can be transmitted between systems without losing meaning or context, and HL7 Reference Implementation Model or other appropriate standards are recommended for implementing concepts; (5) architecture—to develop mHealth systems, developers should define the system architecture that should include data elements and business logic. Furthermore, to define how mHealth systems interact with other systems, developers of mHealth solutions must provide application programming interfaces. FHIR is the preferred application programming interface interoperability standard.

Inclusion and Equitable Access

Inclusion and equitable access are essential principles to ensure that health apps are culturally appropriate and relevant and accessible to everyone, regardless of gender, ethnicity, location, or economic status.

All the included regulatory standards [ 18 , 47 , 48 ] indicate that they were developed based on a combination of participatory and consultative approaches involving multiple actors or stakeholders, thus promoting inclusion. However, there are no specific measures or guidance to ensure adequate engagement and representation of all the relevant stakeholders and to sustain that engagement.

The Kenya Standards and Guidelines for mHealth Systems [ 18 ] proposes the following systems attributes to ensure equitable access to mHealth services at all times and from anywhere: (1) allocation of adequate storage and bandwidth capacity; (2) fast response time; (3) fast recovery capabilities; (4) performance monitoring; (5) business continuity processes, for example, backups; and (6) redundant sites and links. Furthermore, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] prescribes the following metrics for measuring system availability: (1) downtime per year, (2) mean time between failure, (3) mean time to repair, and (4) failure in time.

Although the abovementioned systems attributes and metrics for measuring system availability are important, the included standards do not offer any concrete guidance or model for achieving a sustainable funding mechanism for health apps to ensure that they are readily available and accessible to those who need them.

Context: Reasons Why Those Aspects Are Regulated

The 3 standards [ 18 , 47 , 48 ] were developed to address unsafe, isolated, and inconsistent implementation. The Health Sector ICT Standards and Guidelines [ 48 ] suggest that although there has been a lot of ICT investment in the health sector leading to improvement in service delivery and information exchange, there remains the challenge of inconsistency in ICT implementation and harmonization of the health sector system requirements. Hence, there is a need to adopt global best practices for software development, acquisition, support, and maintenance by the MOH. In addition, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] indicates that standards and guidelines are necessary to ensure a consistent approach to the development of ICT systems. Similarly, the Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] recognize the need to ensure that the processes of collecting, collating, analyzing, interpreting, disseminating, and using data are consistent with data quality standards.

To build mutual trust and maximize the benefits of eHealth information exchange, the Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] reiterate that as health data are constantly being exchanged across health information systems, robust security standards are required to maintain their integrity and confidentiality. This will build the trust of service users and consequently help to maximize the benefits of eHealth information exchange such as in self-management.

Two of the included regulatory standards [ 47 , 48 ] indicate that the context for standards and interoperability was (1) to address poor coordination, duplication of efforts, and inefficient use of resources and (2) to promote the integration of ICT systems.

The Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] acknowledge that the absence of interoperability standards over the years has led to the duplication of efforts and the inefficient use of ICT resources in health care. Now that ICT has become increasingly relevant in improving efficiency in health service delivery, the Kenya MOH recognizes the need to adopt a standardized approach, hence the development of interoperability standards for eHealth systems. In addition, the Health Sector ICT Standards and Guidelines [ 48 ] emphasize the relevance of interoperability as a requirement for addressing the inconsistency in implementing ICT in the health sector.

The Health Sector ICT Standards and Guidelines [ 48 ] consider “integration of ICT systems” as one of its key guiding principles, acknowledging the lack of information systems integration as a challenge experienced by ICT services across Kenya.

The contexts for inclusion and equitable access as generated from included standards [ 18 , 47 , 48 ] were (1) to promote inclusion and (2) to promote equitable access to services.

To promote inclusion, the standards [ 18 , 47 , 48 ] highlight the importance of involving and engaging multiple actors and stakeholders during the development process. However, no emphasis was placed on the need to sustain stakeholder engagement during the implementation process.

Pertaining to equitable access, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] acknowledges that the public health care system is largely unavailable to most of the population in many developing countries because of geographical location, resource constraints, inefficiencies, and lack of awareness. Hence, it recognizes the importance of ensuring that mHealth services are always accessible by users and from anywhere as well as the need to put in place mechanisms to make this happen.

Process: How the Regulations Are Developed and Implemented

Two themes were generated from the included standards: development and implementation processes [ 18 , 47 , 48 ].

Development Process

All the included standards [ 18 , 47 , 48 ] indicate that they were developed through a participatory process and in consultation with a range of subject experts and interest groups. In addition, the standards [ 18 , 47 , 48 ] adopted a multisectoral approach to engage health-related stakeholders from government ministries or agencies and development partners and a range of subject experts and interest groups. It has also been reported that these standards [ 18 , 47 , 48 ] were developed based on international best practices and with reference to international standards. However, there is no indication that a stakeholder engagement strategy was adopted to sustain the engagement of stakeholders through the entire development and implementation process.

Implementation Process

The 3 regulatory standards [ 18 , 47 , 48 ] identify the key requirements to ensure effective implementation of IT services in the health sector. These are (1) legal authority, (2) coordination, (3) building capacity, and (4) monitoring and evaluation.

The included standards [ 18 , 47 , 48 ] were established based on the legal provisions enshrined in the health and other related acts and laws of Kenya as well as the relevant policies and strategies. Hence, it is expected that their implementation will comply with and be backed by those legal provisions. For example, the Health Sector ICT Standards and Guidelines [ 48 ] indicate that its implementation will be supported by the authority from the Kenya Communications Act 2009, E-Government Strategy, and National ICT Policy. Similarly, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] asserts that it will be implemented by complying with existing and relevant national policies, legal frameworks, strategies, and standards, including the Health Information Policy, ICT Standards, and System Interoperability Principles.

The included standards [ 18 , 47 , 48 ] report that the implementation of regulations will require robust coordination mechanisms. For instance, the Health Sector ICT Standards and Guidelines [ 48 ] indicate that, as the Ministry’s ICT resource manager, the principal secretary (also the head of ICT), in collaboration with the ICT Governance Committee, is responsible for coordinating the implementation of the standard. The ICT Governance Committee comprises representatives from the heads of departments and ICT development partners in the health sector. The committee’s responsibilities include overseeing, enforcing, and reviewing standards as well as initiating ICT projects.

The Health Sector ICT Standards and Guidelines [ 48 ] highlight the need for capacity building or training of the MOH staff and stakeholders who are the primary users of the Ministry’s ICT services. This will enhance their capacity to implement the guidelines provided in the document in line with the ministry’s human resource development policies, regulations, and rules. However, it is acknowledged that building capacity for health ICT is a challenge given that there is low adoption of ICT among health providers, and ICT is not routinely included in the course content of most training programs. The Kenya Standards and Guidelines for mHealth Systems [ 18 ] listed the “number of mHealth practitioners trained on the standards and guidelines” as one of the indicators for monitoring and evaluating mHealth interventions.

The Health Sector ICT Standards and Guidelines [ 48 ] assert that monitoring and evaluation is an essential role of the MOH to ensure efficiency, accountability, and transparency throughout the implementation period. It further stresses that all those who use the Ministry’s ICT services are required to adhere to the provisions in the standard as the MOH will carry out quarterly monitoring exercises on the use of the standard to ensure compliance based on clear indicators. Furthermore, the ICT Governance Committee will periodically review and amend the standard to keep it relevant and effective. Similarly, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] establishes the following key indicators for effectively monitoring and evaluating the implementation of the standards and guidelines: (1) the number of counties in which the MOH has disseminated the standards and guidelines, (2) the number of counties successfully implementing the standards and guidelines, (3) the number of mHealth practitioners trained on the standards and guidelines, (4) the number of mHealth practitioners accessing the standards and guidelines, (5) the number of mHealth practitioners who correctly understand the standards and guidelines, (6) the number of stakeholders who adhere to the standards and guidelines, (7) the number of mHealth systems that follow the required development steps, and (8) the number of mHealth practitioners who have implemented their systems by using the standards and guidelines. In addition, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] indicates that the outlined standards will be reviewed every 3 years to ensure they are up to date with new changes including the changes in policies and systems upgrades.

Although all the abovementioned indicators are relevant, the implementation process is not explicit on the approach for regulating health apps and ensuring compliance with regulatory standards and guidance.

Actors: Those the Regulations Are Targeted at

The included standards [ 18 , 47 , 48 ] identified 2 main groups of actors for whom the regulations and guidance were targeted. They included (1) those who provide digital health services and (2) those who use the ICT infrastructure of the MOH.

Two of the standards [ 47 , 48 ] indicated that the regulations should be implemented by all individuals and organizations that provide ICT-related health care services to the public. Similarly, the Health Sector ICT Standards and Guidelines [ 48 ] state that all those who access or use the MOH ICT infrastructure are expected to adhere to the guidelines outlined in the document.

Mapping of Stakeholders

To address the third research question, we conducted a stakeholder mapping guided by the RISA tool [ 41 ].

A total of 11 categories of key stakeholders were identified from all 49 included documents (6 stand-alone regulatory standards and guidance, 35 national policies or strategies, and 8 other related documents). These categories are consistent with the digital health stakeholders recognized by the WHO, ITU, and UNESCO [ 32 , 33 , 43 ]. Table 2 presents the mapping of stakeholders according to their role categorization. A more detailed table with a potential role description with regard to regulating health apps for self-management is presented in Multimedia Appendix 4 .

a WHO: World Health Organization.

This paper presents the findings of a scoping review of regulatory standards and guidance for the use of health apps for self-management in sub-Saharan Africa. To the best of our knowledge, this is the first study that attempted to identify and assess the extent to which regulatory standards and guidance regulate and guide the use of health apps for self-management in sub-Saharan Africa as well as map out the key stakeholders and their potential roles.

Our findings reveal that only 1 country (Kenya) in sub-Saharan Africa currently has national regulatory standards that could potentially regulate the use of health apps for self-management. The included standards failed to adequately address adequate attention to inclusion and equitable access. This is concerning given the growing need to promote the adoption of culturally appropriate and relevant health apps and to ensure that they are available to those who need them regardless of gender, ethnicity, geographical location, or financial status [ 24 - 29 ]. Consequently, this review provides insights into the regulation of health apps for self-management in sub-Saharan Africa, which needs to be given more attention if the potential of these apps is to be harnessed in the region.

Principal Findings

We identified 49 documents from 31 countries in sub-Saharan Africa. Although none of the included standards provided a specific set of regulations on health apps for self-management, we identified 3 standards [ 18 , 47 , 48 ] that provided relevant information regarding the regulation of health apps. The included national policies and strategies, in contrast, only outline the goals and commitments made by national governments to promote the adoption of digital technologies in the health sector and the plans and paths set forth to achieve these goals. However, the information they provided was relevant for identifying and mapping digital health stakeholders who potentially have vital roles in regulating the use of health apps for self-management.

The policy analysis framework (content, context, process, and actors) [ 42 ] was adapted and applied to organize the key findings. The content covered the following areas: guidance on systems quality; guidance on software and app development, acquisition, support, and maintenance; security measures for adequate protection of patients’ digital records; guidance on data exchange; interoperability as a basic requirement; minimum standards to enable integration; involvement and engagement of relevant stakeholders; and system attributes for equitable access to services. Meanwhile, the context was to address unsafe, isolated, and inconsistent implementation; to build mutual trust and maximize the benefits of eHealth information exchange; to address poor coordination, duplication of efforts, and inefficient use of resources; to promote the integration of ICT systems; and to promote inclusion and equitable access to services. The process involved the development process (which covers participatory and consultative processes and multisectoral approach, with reference to international standards and best practices) and the implementation process (which covers legal authority, coordination, capacity building, and monitoring and evaluation). The targeted actors were those who provided digital health services and those who used the ICT infrastructure of the MOH.

Furthermore, key stakeholders with potential roles in regulating health apps for self-management were identified. They include the government, regulatory bodies, funders, intergovernmental and nongovernmental organizations, academia, and the health care community.

Implications of the Study Findings for Practice

Regulatory standards and guidance act as a bridge between technological innovation and its safe and effective use in health care. They ensure that while technology continues to advance, the safety and trust of patients are never compromised. Among the plethora of health apps on the market, the over-the-counter, nonregulated apps such as wellness and fitness apps are the most mainstream [ 93 - 95 ]. On the other side of the spectrum, there are regulated health apps that are classified under medical devices or software as medical device products [ 94 , 95 ]. Some of these are prescription-only apps, such as digital therapeutics (DTx) apps for managing substance dependence [ 95 , 96 ].

Although some high-income countries have made significant strides in ensuring the safety, effectiveness, and accessibility of health apps, the journey has indeed not been without challenges and hurdles. Sub-Saharan Africa, although dealing with its own unique set of challenges, has the opportunity to learn from the experiences of these high-income countries. This could potentially allow the region to bypass some of the hurdles encountered by high-income countries in their journeys.

Technical and clinical safety are essential requirements that health apps must meet before they can be considered for use for self-management to minimize the risk of harm to patients. It is well documented that health apps that function poorly pose a serious threat to the safety of patients. An example illustrating how health apps used for self-management can threaten patient safety is evident in a study [ 12 ]. This study [ 12 ] revealed that widely used health apps designed to calculate and estimate insulin doses could endanger patients by providing incorrect or inappropriate dose recommendations. Similarly, 2 successive studies that assessed the contents and tools of apps for asthma discovered that none of the apps in the first study offered comprehensive information or adequate tools for asthma self-management, whereas the follow-up study, which was conducted 2 years later, showed a 2-fold increase in the number of asthma apps, yet there was no improvement in the content and tools offered by the newer apps. In fact, many apps recommended self-management procedures that were not supported by evidence [ 13 , 14 ]. Accordingly, some health apps that support the self-management of long-term conditions do not adhere to evidence-based guidelines and are unresponsive to the evolving health needs of patients.

Although the context of included regulatory standards with regard to technical and clinical safety was to address unsafe, isolated, and inconsistent implementation, the guidance provided by these regulatory standards is not specific to health apps, and they do not provide appropriate guidance and standards for health organizations and other key stakeholders to establish a framework for managing the clinical risks associated with deploying and implementing self-management health apps. Considering the rapid advancements in digital health (including artificial intelligence [AI] or machine learning and big data), health apps will increasingly play a crucial role in supporting self-management through digitally enabled care pathways that will improve personalized care and health outcomes [ 97 , 98 ]. Therefore, it is imperative to ensure the technical reliability and clinical safety of health apps for self-management through robust regulatory standards and guidance. For instance, a guide on the criteria for health app assessment, developed by the UK government, includes technical stability and clinical safety as criteria for deciding whether health apps should be considered for use in the National Health Service (NHS) [ 99 ]. In addition, medical device apps are required to conform to the NHS clinical risk management standards as part of the clinical safety requirements [ 99 , 100 ]. In the event of any concerns regarding the safety of a medical device app, the Yellow Card reporting system can be used by a responsible clinical safety officer or any other individual to notify the Medicines and Healthcare products Regulatory Agency (MHRA) [ 101 , 102 ].

To adequately manage patient information when health apps are used for self-management, data protection and security standards and guidance are required. They guarantee that data are kept and handled safely and responsibly within the provisions of the law and that patients’ rights and interests are respected.

There have been ongoing concerns about compliance with ethical standards, the principles of confidentiality of information, and data privacy. For example, an assessment of apps that had previously been endorsed by the former UK NHS Apps Library revealed substantial gaps in compliance with data protection principles regarding the collection, storage, and transmission of personal information. This has raised a fundamental concern about the credibility of developer disclosures and whether these disclosures can be trusted by certification programs [ 15 ]. A study assessed the privacy practices of the 36 most popular apps for depression and smoking cessation for Android and iOS in the United States and Australia [ 16 ]. The findings revealed that although only 69% (25/36) of the apps included a privacy policy, 92% (33/36) of the apps shared data with a third party, and only 92% (23/25 with privacy policy) of the apps disclosed sharing data with a third party in their policy. Although 81% (29/36) of the apps shared data with Google and Facebook for the purposes of advertising, marketing, or analytics, only 43% (12/28) of the apps that shared data with Google and 50% (6/12) of the apps that shared data with Facebook disclosed this in their policy [ 16 ].

In this regard, health app developers and providers in the United Kingdom are required to conduct a data protection risk assessment before they launch or update their apps to ensure compliance with the United Kingdom General Data Protection Regulation (GDPR) and other relevant regulations, including the Data Protection Act 2018 [ 103 ]. By conducting a data protection risk assessment, health app developers and providers can demonstrate that they are accountable; they respect the privacy and dignity of their users; and that they deliver safe, effective, and ethical solutions [ 104 ].

Health apps are expected to play an increasingly important role in supporting self-management. However, this ambition can only be achieved if citizens trust that these apps are collecting and analyzing data safely and in accordance with robust regulatory standards and guidance. It is also crucial that these apps provide reliable information that clinicians can act on [ 98 ]. The context of the standards included in this study regarding data protection and security was to build mutual trust and maximize the benefits of eHealth information exchange. Trust is a key factor in the successful adoption and use of health apps, and transparency in data handling and clinical decision-making is essential to build and maintain that trust. This is also paramount for the widespread acceptance and impact of health apps on health care outcomes in sub-Saharan Africa.

We acknowledge the existence of numerous national laws related to data protection and security outside the health sector. Hence, guidelines that link these legislations together must be provided to ensure compliance with all relevant laws and guidance when using patient data. An example of how to achieve this is the United Kingdome’s guide to good practice for digital and data-driven health technologies that provides guidelines on how to abide by the laws and principles that govern data security and protection in the United Kingdom, including the GDPR, Data Protection Act 2018, and Caldicott Principles [ 105 ].

Standards and interoperability are essential for effectively developing, deploying, and implementing health apps to support self-management in sub-Saharan Africa. Interoperability is the ability of different systems, devices, or applications to communicate and exchange data with each other in a coordinated manner, thus providing timely and seamless portable information across organizational, regional, and national boundaries and optimizing both individual and population health [ 106 ]. In the same vein, standards enable interoperability between systems or devices through a common language and a common set of expectations [ 106 ].

Interoperability is crucial in improving the quality, safety, and efficiency of care delivery as well as empowering patients and providers with access to relevant and timely information [ 99 ]. One of the most widely used and accepted interoperability standards for health care data exchange is FHIR [ 106 , 107 ]. FHIR is a global industry standard developed by HL7 International. FHIR is designed to be quick to learn and implement and to support a variety of use cases, including self-management [ 108 ]. By using apps that are based on an FHIR standard, patients can benefit from data analytics that show how their health data relate to their chronic conditions or wellness goals [ 109 ]. They could also access all their health information from one place, even if they visit different health professionals who use different electronic medical records or EHR, thus promoting integrated care [ 28 , 31 , 33 , 109 - 115 ]. As a result, patient care can easily be coordinated.

The context of the included regulatory standards with regard to standards and interoperability was to address poor coordination, duplication of efforts, and inefficient use of resources and to promote the integration of ICT systems. However, in sub-Saharan Africa, there are many challenges and barriers to the adoption and implementation of interoperability standards, such as the lack of awareness or knowledge of the benefits and requirements of interoperability standards among stakeholders; lack of incentives or regulations to encourage or enforce the adoption of interoperability standards by app developers and vendors; lack of resources or capacity to implement interoperability standards, including technical expertise, infrastructure, funding, or governance; and lack of alignment or coordination among the different actors and initiatives involved in developing, deploying, and implementing the digital health interventions [ 30 , 116 - 119 ]. To address these challenges, some possible solutions may include raising awareness and education on the importance and value of interoperability standards for health apps among all relevant actors; developing and implementing policies and guidelines that promote or mandate the use of interoperability standards by app developers and vendors; providing technical assistance and support for app developers and vendors to adopt and implement interoperability standards, such as tools, frameworks, testing, certification, or accreditation; and establishing and strengthening collaboration and coordination among the different stakeholders and initiatives involved in health app development, deployment, and implementation in sub-Saharan Africa. In addition, the Digital Health Platform Handbook, a toolkit developed by the collaborative efforts of the WHO and ITU [ 120 ], can help countries in sub-Saharan Africa to develop and implement digital health platforms as the underlying infrastructure for interoperable and integrated national digital health systems. The digital health platform is a system-wide approach to developing digital health solutions with the aim to overcome the problems of siloed, vertical, and isolated applications and systems that hamper data management, innovation, efficiency, and impact in the health sector.

Inclusion and equitable access are crucial to ensuring that health apps and related services are culturally appropriate and relevant as well as accessible to all who need them, regardless of gender, ethnicity, geographical location, ability, or financial status [ 24 - 29 ]. This is the key to promoting a “sense of belonging” and “ownership” and thus underscoring the importance of stakeholder mapping and involvement or engagement through the development and implementation process [ 22 ].

In this study, the included regulatory standards demonstrate the importance of inclusion by adopting both a participatory and consultative approach involving multiple stakeholders from different sectors. However, the standards do not provide clear guidance to ensure the adequate participation and sustained engagement of all relevant stakeholders. The lack of concise guidance to ensure the adequate participation and engagement of all relevant stakeholders, especially the susceptible and disadvantaged groups, can increase the risk of tokenistic tendencies, which can undermine the cultural appropriateness of health apps [ 25 , 121 ]. Some susceptible groups, such as women and people with low socioeconomic status, may face additional barriers to accessing and using health apps, such as lack of digital literacy, privacy concerns, cultural norms, or stigma [ 25 ]. Similarly, the cost of developing, maintaining, and updating health apps may not be covered by public or private health insurance schemes, which could limit their affordability and availability for low-income or uninsured populations [ 95 ]. However, there is no specific guidance or model for an effective funding mechanism for health apps in the included regulatory standards.

To address these challenges and ensure equitable access to health apps for self-management in sub-Saharan Africa, possible measures may include developing policies and regulations that support integrating health app interventions into existing health systems and financing mechanisms and engaging with stakeholders from different sectors and backgrounds (including health professionals, patients, communities, governments, civil society, academia, and industry) to co-develop and co-implement frameworks or models that promote the use of health apps for self-management in ways that are responsive to the local context and needs. Moreover, establishing regulations that provide appropriate financing or reimbursement options will reduce the risk of developers of good quality health apps turning to data mining for revenue, thus increasing privacy concerns [ 95 ]. For instance, in Germany, the reimbursement of health apps classified as medical devices (Digitale Gesundheitsanwendungen) was introduced in 2021 under the statutory health insurance [ 122 , 123 ]. When a medical device is prescribed by a physician or a physiotherapist, the manufacturer must submit an application to the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) for approval [ 123 ]. The Federal Association of the Statutory Health Insurance Funds (Spitzenverband Bund der Krankenkassen) determines and negotiates the reimbursement thresholds following approval. However, the manufacturer must demonstrate that the app is safe, functional, and of good quality; complies with data protection requirements; and benefits patient care [ 123 ].

The process of regulating health apps essentially involves the development and implementation of regulatory standards and guidance. According to our study, the development process comprises a participatory and consultative process, a multisectoral approach, and a reference to international standards and best practices. In contrast, the implementation process is ongoing and requires appropriate legal authority, coordination, capacity building, and monitoring and evaluation.

We recognize that health apps can be accessed and used by patients from different parts of the world, and this means that countries need to carefully consider whether health apps that are accessed and used by their citizens meet the national or regional legal and ethical requirements, including their cultural and linguistic needs [ 23 ]. For countries in sub-Saharan Africa, a cross-border or regional collaboration between national legal authorities through the coordination of agencies such as the African Medicines Regulatory Harmonization (AMRH) may help to ensure that health apps built for the region are safe, effective, and user-friendly for everyone, considering the contextual differences of the countries [ 23 ]. For instance, all medical device companies that want to sell their products in the European market must obtain a Conformité Européenne (CE) mark for their devices, which indicates that they meet the legal requirements and can be freely circulated within the European Union [ 124 ]. Although the European Union member states regulate medical devices, the European Medicines Agency is involved in the regulatory process.

The regulation of health apps is extremely complex and involves a wide range of stakeholders. Therefore, a robust coordination mechanism is essential to reduce the risk of fragmentation and duplication of efforts and to promote the efficient use of resources. Most countries in sub-Saharan Africa have units in health ministries that coordinate and oversee the regulation of medical products. These units should be autonomous, full-fledged departments with legal authority (boards or commissions) to ensure independent, transparent, and accountable decision-making, but this is often not the case [ 125 ]. These units are recognized by the national authorities as regulators (eg, the National Medicines Regulatory Authority [NMRA]) [ 126 ]. Such organizational structures hinder the effectiveness of the national regulatory authorities in fulfilling their mandate and prevent the establishment of quality management systems to ensure transparent and accountable decision-making [ 125 ].

Furthermore, Essén et al [ 23 ] analyzed health app policy or regulation in 9 high-income countries (Sweden, Norway, Denmark, Netherlands, Belgium, Germany, England, the United States, and Singapore) and found that most of these countries adopted centralized approaches to app evaluation. Although centralized approaches might have advantages over self-evaluation, they may create bottlenecks and limit the availability of high-quality health apps for users. As suggested by Essén et al [ 23 ], a decentralized approach, such as the accreditation of evaluation agencies, maybe a worthwhile solution. However, this will require adequate coordination to ensure the consistency and reliability of the evaluation criteria and methods across different agencies as well as the transparency and accountability of the accreditation process. A possible way to achieve this is to adopt a common framework that can guide the evaluation and accreditation of health apps.

Similarly, the postmarket surveillance (PMS) system, which is a new regulation for medical devices in Europe, is a process of collecting and analyzing data on medical devices after they have been launched into the market to ensure their safety and performance and to identify any problems or need for improvements [ 127 , 128 ]. The PMS system is important because premarket data, which are obtained from testing a medical device before it is launched, have limitations in capturing the long-term performance and risks of the device [ 128 ]. Currently, the PMS system does not cover fitness and wellness apps, which are commonly used in self-management. Hence, Yu [ 93 ] proposed that the PMS system should also be applied to DHTs, such as fitness and wellness apps. They argue that the postmarket data would help regulators periodically review and adjust the regulatory standards for these groups of health apps based on their risks and benefits.

Drawing on the experience of the United Kingdom, it can be clearly demonstrated that the regulation of health apps is a complex, a multifaceted, and an evolving process that involves different regulators and criteria depending on the nature and function of the app. For instance, a centralized NHS Apps Library was launched as a beta site in April 2017 to provide patients with a collection of trusted and easy-to-use digital health tools [ 129 ]. The library provided access to a range of health apps that were reviewed and approved by the NHS, including apps that could help patients manage conditions such as diabetes, mental health, and chronic obstructive pulmonary disease [ 130 ]. However, the library was closed in December 2021 [ 131 ]. Although no reason for the closure was provided on the website, it is likely because of persistent concerns regarding the safety of patients and data privacy involving multiple apps including those listed in the library [ 12 , 14 - 16 , 131 , 132 ]. The NHS App was introduced in January 2019 before the closure of the NHS Apps Library to serve as the gateway for accessing NHS services including ordering repeat prescriptions and booking or managing appointments [ 133 ].

Furthermore, the United Kingdom Health Security Agency, formerly known as Public Health England, issued a guidance on criteria for health app assessment in October 2017 [ 99 ]. The purpose of this guidance was to ensure that all health apps built for the UK population work well and provide clear information about their functions, benefits, and intended outcomes for patients and health care professionals. On the basis of this guidance, those intending to build an app are required to conform to certain regulations before being considered for the app assessment process. The 2 main regulations are the medical device regulation and the Care Quality Commission (CQC) registration. Apps that are considered as medical devices must register with the MHRA and have a CE mark. Apps providing health or social care that fit into 1 of 14 regulated activities are required to register with the CQC before they can be assessed [ 134 ]. CQC is an independent regulator of health and social care services in England.

Similarly, the Organisation for the Review of Care and Health Apps (ORCHA) is a UK-based organization that independently evaluates and distributes health apps. It provides services such as app review, accreditation, curation, and recommendation within the United Kingdom and across the world [ 135 ]. ORCHA also enables organizations (including the NHS) to build a decentralized web-based digital health library of consumer-friendly over-the-counter apps [ 135 - 137 ]. These apps are continuously assessed by ORCHA against the standards and regulations in clinical and professional assurance, data quality and privacy, and usability and accessibility [ 137 ].

In addition, the Digital Technology Assessment Criteria (DTAC) were introduced in beta in October 2020, and its first official version was subsequently launched in February 2021 [ 138 ]. The DTAC plays a crucial role in ensuring that digital health tools meet the necessary standards in areas such as clinical safety, data protection, technical security, interoperability, usability, and accessibility. By serving as the national baseline criteria for DHTs in the NHS and social care, it provides a valuable framework for health care organizations during procurement. It also offers guidance for developers on the expectations for their digital technologies within the NHS and social care. This is an example of how a harmonized framework can help ensure the quality and safety of DHTs, including health apps.

In addition, the National Institute for Health and Care Excellence Evidence Standards Framework is a set of evidence standards for a wide range of DHTs designed to help evaluators and decision makers in the health care system to consistently identify DHTs that are likely to offer benefits to the users and the health care system [ 139 ]. The Evidence Standards Framework was first published in March 2019 and is ideally used before DHTs (including health apps) are considered for commissioning or procurement by the NHS [ 140 ]. It is a crucial tool for ensuring that DHTs are clinically effective and offer value to the health and care system in the United Kingdom. In August 2022, the framework was updated to include AI and data-driven technologies with adaptive algorithms [ 140 ].

Furthermore, DTx apps, which are a type of medical device, are not allowed into the UK market unless they comply with the UK GDPR and meet the requirements of DTAC. In addition, they must bear the CE or UK Conformity Assessed marks [ 141 ]. This means that DTx apps must demonstrate their safety and efficacy through clinical trials and comply with the relevant regulations for data protection and quality standards as regulated by the MHRA. DTx products are also recognized as DHTs under the National Institute for Health and Care Excellence Evidence Standards Framework [ 142 ]. DTx incorporates software to treat, prevent, or manage specific diseases or conditions [ 143 , 144 ]. The fact that DTx products typically focus on a narrow clinical indication and generate evidence of clinical efficacy underscores their potential to make a substantial contribution to self-management and health care delivery in general. The increasing recognition of the role of DTx in patient care by regulators is also noteworthy, and the creation of regulatory and reimbursement pathways for approved apps further enables DTx products to continue to play an important role in impacting health care delivery [ 1 , 143 ]. This is a testament to the potential of regulated health apps to revolutionize health care and improve patient outcomes.

Among the many lessons to learn from the experience of the United Kingdom is that the regulation of health apps must evolve to keep pace with advances in DHTs and adapt to the changing needs and demands of digital health. Moreover, efforts are being made to streamline the multifaceted approaches to simplify app regulation and access in the United Kingdom [ 23 ]. Therefore, a robust and dynamic coordination mechanism, along with political will, skilled personnel, reliable funding, and a robust framework for monitoring and evaluating progress and aligning key performance indicators, is essential for countries in sub-Saharan Africa to keep pace with the advancement in the regulation of health apps. There is also a need to strengthen collaboration and ensure regulatory harmonization among national regulatory authorities and continental bodies such as the regional economic communities, AMRH, and the WHO AFRO [ 126 ].

Capacity building and monitoring and evaluation are important factors for ensuring effective regulation of health apps given the complex nature of the process. The regulation of medical products (including health apps) in sub-Saharan Africa generally includes licensing and accreditation, evaluation, inspection, quality control, information dissemination and promotion, and monitoring of adverse events [ 125 ]. Therefore, high-level skills as well as effective monitoring and evaluation will be required to ensure the success of the process. For most countries in sub-Saharan Africa, the NMRA is responsible for coordinating and overseeing the regulatory system of medical products [ 125 , 126 ]. However, in most cases, NMRAs are unable to perform the core regulatory functions expected of them [ 145 ]. More than 90% of African countries have limited or no capacity to regulate medical products, with only 7% having moderately developed capabilities [ 145 ]. The lack of effective NMRAs in Africa exposes the citizens to potential harm by allowing unsafe, low-quality, and fake medical products to circulate and be used [ 145 ].

Although it is the responsibility of governments to establish functional regulatory systems and ensure effective monitoring and evaluation of the regulatory process, the involvement of international and continental organizations to support sub-Saharan African countries improve the regulatory capacity of their national regulatory agencies would be extremely beneficial. For instance, the African Medicines Agency (AMA) was established in November 2019 as a treaty adopted by the African Union Member States to help address the concerns arising from weak regulatory systems on the continent. At present, 37 countries have signed the AMA treaty, including 26 countries that have ratified it [ 146 ]. The main objective of the AMA is to enhance the capacity of States Parties and regional economic communities to regulate medical products to improve the quality, safety, and efficacy of medical products on the continent [ 147 ]. The AMA, in collaboration with other existing capacity building initiatives or organizations, such as the WHO Global Initiative on Digital Health, ITU, AMRH, WHO AFRO, and United Nations Children’s Fund, can assist sub-Saharan African countries in aligning their regulatory requirements with available resources and support them to acquire the necessary tools and skills to build effective and sustainable regulatory systems for health apps. This can be achieved by adopting a decentralized approach to engage a network of technical experts across the African Union similar to the model of the European Medicines Agency [ 148 ].

Actors or Stakeholders

The regulation of health apps often requires working with a wide range of actors or stakeholders. However, in this review, we identified only 2 main actor groups (those who provide digital health services and those who use the ICT infrastructure of the health ministry). These are the groups that are targeted by the included regulatory standards.

From a broader perspective, 12 categories of stakeholders according to their potential role in regulating health apps for the self-management were mapped in this study. The potential contribution of these stakeholders to the regulation of health apps for self-management in sub-Saharan Africa not only depends on their roles and responsibilities but also on their interests, needs, expectations, and influence [ 41 , 149 - 151 ]. Thus, a robust stakeholder analysis is paramount as it can help define the scope of the regulatory process, prioritize the requirements, manage the expectations, and ensure the engagement and participation of stakeholders throughout the regulatory process [ 41 , 152 - 156 ]. Our stakeholder mapping, as presented in Table 2 (refer to Multimedia Appendix 4 for more details), lays the foundation for national governments to conduct a robust stakeholder analysis and to adopt an all-inclusive stakeholder engagement strategy to manage and sustain the engagement and participation of all relevant stakeholders [ 157 , 158 ].

Recommendations

Our review found that the regulation of health apps in sub-Saharan Africa is especially poor and almost nonexistent, as only Kenya has national standards that could address some of the regulatory issues related to health apps. Therefore, we recommend the following actions to help sub-Saharan African countries improve the regulation of health apps to support self-management:

• Establish a clear and consistent definition of what constitutes a health app (considering AI or machine learning) and what level of regulation is required for different types of apps.
• Develop and implement criteria and guidelines that ensure the quality, safety, and usability of health apps.
• Engage with independent app evaluators, such as ORCHA, to adopt a common framework that can guide the evaluation and accreditation of health apps and use the framework to create and maintain decentralized and transparent platforms that showcase and evaluate health apps for users and health care professionals.
• Develop and implement policies and regulations that enable sustainable funding for health apps such as integrating the use of health apps for self-management into existing health systems and financing pathways or mechanisms.
• Support and facilitate innovation and collaboration across the sub-Saharan Africa region, especially in areas including but not limited to data security and privacy, interoperability standards, usability, accessibility, funding, capacity building, and monitoring and evaluation of the regulatory process.
• Manage and sustain the engagement, involvement, and participation of all relevant stakeholders in the regulatory process by conducting a robust stakeholder analysis and adopting an all-inclusive stakeholder engagement strategy.

Strengths and Limitations of the Study

This study has several strengths, which include an extensive search of gray literature and repositories, contact with key individuals, and the use of a systematic approach. Given that regulatory standards and guidance are unavailable in scientific databases, a wide range of gray literature and repositories were searched. In addition, contact was made with key staff members to obtain relevant documents, including those at the MOHs, the WHO country offices, and the WHO AFRO. Second, to enhance the strength of the study, a policy analysis framework was adapted and used to systematically organize the key study findings, whereas a deductive descriptive qualitative content analysis approach was used to identify and analyze texts that contained relevant concepts and other related information based on the 4 predefined themes. Third, the RISA tool was used to guide the mapping of key stakeholders. This has further increased the robustness of the study findings.

The limitations of this study include the fact that our literature search was conducted in English. Although the literature search was conducted in English, it yielded documents written in French and Portuguese from the ICTworks repository. Second, regulatory standards and guidance are not readily available on scientific databases; hence, it is possible that some relevant documents might have been missed. However, efforts were made to obtain these documents by contacting key stakeholders including key contact persons at the WHO AFRO, WHO country offices, and MOHs. In addition, contacting key individuals only for the purposes of requesting documents rather than conducting direct interviews was one of the limitations of this study. Interviewing key contact persons and stakeholders to obtain additional information could have strengthened the review; however, we did not interview any key individuals or stakeholders because it was beyond the scope of this review. Nonetheless, we recommend that future studies consider incorporating interviews to explore the perspectives of key stakeholders.

Conclusions

Health apps are increasingly being used by patients to manage their health, and sub-Saharan African countries can leverage these apps to advance their progress toward achieving SDG 3 (good health and well-being) and UHC, especially given the rapid advancement of AI and big data. However, our study has established that the regulation of health apps in sub-Saharan Africa is inadequate to ensure that health apps are technically reliable and clinically safe; interoperable across systems; compliant with the principles of confidentiality of information and data privacy; culturally appropriate and relevant; and accessible to everyone regardless of gender, ethnicity, location, or income. Therefore, the region can learn from the experiences of some high-income countries such as the United Kingdom and Germany to develop and implement a robust and responsive regulatory system that supports the widespread adoption of safe, effective, and beneficial health apps for its population.

Following the publication of this review, a summary of the findings will be disseminated to the relevant organizations. In addition, the key findings will be summarized and presented at national, regional, and international conferences.

Acknowledgments

The authors would like to thank Rebecca Jones, the Library Manager and Liaison Librarian at Charing Cross Library, who advised and assisted with the search strategy for this study. This work is part of the PhD research of BAB, which is sponsored by the government of Nigeria. AM and JC were supported by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration Northwest London (NIHR200180). The views expressed in this publication are those of the authors and not necessarily those of the government of Nigeria or the NIHR or the Department of Health and Social Care. In the Results and Discussion sections, Microsoft Copilot in Bing [ 159 ] was used to help summarize and modify a few texts as well as suggest some citations.

Data Availability

The search strategy for PubMed, Scopus, and the World Health Organization AIM is presented in Multimedia Appendix 1 . All data generated or analyzed during this study are included in this published article (and its supplementary information files). The documents analyzed are available directly from the relevant institutional websites, ICTworks repository [ 44 ] or upon request from the relevant government departments in each country. Additionally, documents in the list of references that are not accessible on the web can be solicited from the corresponding author on reasonable request.

Authors' Contributions

BAB and JC conceived the study. BAB designed the study with contributions from JC and NM. BAB drafted the manuscript, and JC, NM, AM, SI, KPF, BIH, and NU read and contributed to it. AM was the clinical lead, and JC acted as a guarantor for this study. The final manuscript was read and approved by all the authors.

Conflicts of Interest

None declared.

PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist.

Database search strategy.

Details of included documents.

Mapping of the stakeholders according to their potential role in regulating health apps for self-management.

• Aitken M, Nass D. Digital health trends 2021: innovation, evidence, regulation, and adoption. IQVIA Institute for Human Data Science. 2021. URL: https:/​/www.​iqvia.com/​-/​media/​iqvia/​pdfs/​institute-reports/​digital-health-trends-2021/​iqvia-institute-digital-health-trends-2021.​pdf?&_=1669449368070 [accessed 2022-11-26]
• Mobile app threat landscape report. RiskIQ. 2020. URL: https://www.riskiq.com/2020-mobile-threat-landscape-report-thank-you/ [accessed 2021-07-19]
• El-Sappagh S, Ali F, Hendawi A, Jang JH, Kwak KS. A mobile health monitoring-and-treatment system based on integration of the SSN sensor ontology and the HL7 FHIR standard. BMC Med Inform Decis Mak. May 10, 2019;19(1):97. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Labrique AB, Vasudevan L, Kochi E, Fabricant R, Mehl G. mHealth innovations as health system strengthening tools: 12 common applications and a visual framework. Glob Health Sci Pract. Aug 06, 2013;1(2):160-171. [ FREE Full text ] [ CrossRef ]
• Adepoju IOO, Albersen BJA, De Brouwere V, van Roosmalen J, Zweekhorst M. mHealth for clinical decision-making in sub-Saharan Africa: a scoping review. JMIR Mhealth Uhealth. Mar 23, 2017;5(3):e38. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Vegesna A, Tran M, Angelaccio M, Arcona S. Remote patient monitoring via non-invasive digital technologies: a systematic review. Telemed J E Health. Jan 2017;23(1):3-17. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Use of appropriate digital technologies for public health: Report by the Director-General. World Health Organization. 2016. URL: https://iris.who.int/handle/10665/274134 [accessed 2023-05-06]
• El-Osta A, Rowe C, Majeed A. Developing a shared definition of self-driven healthcare to enhance the current healthcare delivery paradigm. J R Soc Med. Nov 2022;115(11):424-428. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Hussein R. A review of realizing the universal health coverage (UHC) goals by 2030: part 2- what is the role of eHealth and technology? J Med Syst. Jul 2015;39(7):72. [ CrossRef ] [ Medline ]
• Sustainable development goal 3: Ensure healthy lives and promote well-being for all at all ages. United Nations. URL: https://sdgs.un.org/goals/goal3 [accessed 2023-05-07]
• Coronavirus: apps to help the elderly. Organisation for the Review of Care and Health Apps. 2020. URL: https://orchahealth.com/coronavirus-apps-to-help-the-elderly/ [accessed 2021-07-19]
• Huckvale K, Adomaviciute S, Prieto JT, Leow MKS, Car J. Smartphone apps for calculating insulin dose: a systematic assessment. BMC Med. May 06, 2015;13:106. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Huckvale K, Car M, Morrison C, Car J. Apps for asthma self-management: a systematic assessment of content and tools. BMC Med. Nov 22, 2012;10:144. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Huckvale K, Morrison C, Ouyang J, Ghaghda A, Car J. The evolution of mobile apps for asthma: an updated systematic assessment of content and tools. BMC Med. Mar 23, 2015;13:58. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Huckvale K, Prieto JT, Tilney M, Benghozi PJ, Car J. Unaddressed privacy risks in accredited health and wellness apps: a cross-sectional systematic assessment. BMC Med. Sep 07, 2015;13:214. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Huckvale K, Torous J, Larsen ME. Assessment of the data sharing and privacy practices of smartphone apps for depression and smoking cessation. JAMA Netw Open. Apr 05, 2019;2(4):e192542. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Ndlovu K, Mars M, Scott RE. Interoperability frameworks linking mHealth applications to electronic record systems. BMC Health Serv Res. May 13, 2021;21(1):459. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Kenya standards and guidelines for mHealth systems. Kenya Ministry of Health. 2017. URL: https:/​/www.​health.go.ke/​wp-content/​uploads/​2020/​02/​Revised-Guidelines-For-Mhealth-Systems-May-Version.​pdf [accessed 2023-03-21]
• Standard for electronic health record system (EHRs) in Ethiopia. Ethiopia Minister of Health. 2021. URL: https:/​/registry.​betterehealth.eu/​ehealth-policies/​standard-electronic-health-record-system-ehrs-ethiopia [accessed 2023-04-21]
• National health normative standards framework for digital health interoperability in South Africa. South Africa Department of Health. 2021. URL: https://www.health.gov.za/wp-content/uploads/2022/10/HNSF_Gazette_21_October_2022.pdf [accessed 2023-05-15]
• Ferretti A, Ronchi E, Vayena E. From principles to practice: benchmarking government guidance on health apps. Lancet Digit Health. Jun 2019;1(2):e55-e57. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Diao JA, Venkatesh KP, Raza MM, Kvedar JC. Multinational landscape of health app policy: toward regulatory consensus on digital health. NPJ Digit Med. May 11, 2022;5(1):61. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Essén A, Stern AD, Haase CB, Car J, Greaves F, Paparova D, et al. Health app policy: international comparison of nine countries' approaches. NPJ Digit Med. Mar 18, 2022;5(1):31. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Brown SA, Garcia AA, Kouzekanani K, Hanis CL. Culturally competent diabetes self-management education for Mexican Americans: the Starr County border health initiative. Diabetes Care. Feb 2002;25(2):259-268. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Chaney SC, Mechael P. Self-Care Trailblazer Group. 2020. URL: https://media.psi.org/wp-content/uploads/2020/09/31000510/Digital-Self-Care-Final.pdf [accessed 2021-05-20]
• Kanzaveli T. Healthcare: shiftingfrom “one size fits all” to “one size fits one”. Medium. 2017. URL: https:/​/tkanzaveli.​medium.com/​healthcare-shifting-from-one-size-fits-all-to-one-size-fits-one-d56136ded705 [accessed 2022-03-04]
• Myth 1 – one app will fit all!. Organisation for the Review of Care and Health Apps. URL: https://orchahealth.com/myth-1-one-app-will-fit-all/ [accessed 2022-03-04]
• Aitken M, Lyle J. Patient adoption of mHealth: use, evidence and remaining barriers to mainstream acceptance. IQVIA Institute for Human Data Science. Sep 2015. URL: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/patient-adoption-of-mhealth.pdf [accessed 2021-05-21]
• Mechael P, Batavia H, Kaonga N. Barriers and gaps affecting mhealth in low and middle income countries: policy white paper. Center for Global Health and Economic Development Earth Institute, Columbia University. 2010. URL: http://www.globalproblems-globalsolutions-files.org/pdfs/mHealth_Barriers_White_Paper.pdf [accessed 2021-03-24]
• Bene BA, Ibeneme S, Fadahunsi KP, Harri BI, Ukor N, Mastellos N, et al. Regulatory standards and guidance for the use of health applications for self-management in Africa: scoping review protocol. BMJ Open. Feb 11, 2022;12(2):e058067. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Aitken M, Gauntlett C. Patient apps for improved healthcare: from novelty to mainstream. IMS Institute for Healthcare Informatics. 2013. URL: https://ignacioriesgo.es/wp-content/uploads/2014/03/iihi_patient_apps_report_editora_39_2_1.pdf [accessed 2024-03-10]
• National eHealth Strategy Toolkit. World Health Organization, International Telecommunication Union. 2012. URL: https://www.itu.int/pub/D-STR-E_HEALTH.05-2012 [accessed 2021-06-28]
• Global strategy on digital health 2020-2025. World Health Organization. 2021. URL: https://www.who.int/docs/default-source/documents/gs4dhdaa2a9f352b0445bafbc79ca799dce4d.pdf [accessed 2021-06-23]
• Arksey H, O'Malley L. Scoping studies: towards a methodological framework. Int J Soc Res Methodol. Feb 2005;8(1):19-32. [ FREE Full text ] [ CrossRef ]
• Anderson S, Allen P, Peckham S, Goodwin N. Asking the right questions: scoping studies in the commissioning of research on the organisation and delivery of health services. Health Res Policy Syst. Jul 09, 2008;6:7. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Levac D, Colquhoun H, O'Brien KK. Scoping studies: advancing the methodology. Implement Sci. Sep 20, 2010;5:69. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Peters MDJ, Marnie C, Tricco AC, Pollock D, Munn Z, Alexander L, et al. Updated methodological guidance for the conduct of scoping reviews. JBI Evid Synth. Oct 2020;18(10):2119-2126. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Tricco AC, Lillie E, Zarin W, O'Brien KK, Colquhoun H, Levac D, et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med. Oct 02, 2018;169(7):467-473. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Leitner C, Potenziani D. Mendeley reference manager. Mendeley. 2022. URL: https://www.mendeley.com/reference-management/reference-manager [accessed 2022-08-03]
• Better systematic review management. Covidence. URL: https://www.covidence.org/ [accessed 2023-02-13]
• Franco-Trigo L, Fernandez-Llimos F, Martínez-Martínez F, Benrimoj SI, Sabater-Hernández D. Stakeholder analysis in health innovation planning processes: A systematic scoping review. Health Policy. Oct 2020;124(10):1083-1099. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Walt G, Gilson L. Reforming the health sector in developing countries: the central role of policy analysis. Health Policy Plan. Dec 1994;9(4):353-370. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Digital health: a call for government leadership and cooperation between ICT and health. Broadband Commission. 2017. URL: https://broadbandcommission.org/wp-content/uploads/2021/09/WGHealth_Report2017-.pdf [accessed 2021-06-28]
• Vota W. Every African country’s national eHealth strategy or digital health policy. ICT works. 2019. URL: https://www.ictworks.org/african-national-ehealth-strategy-policy/ [accessed 2023-12-10]
• Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. Jul 21, 2009;6(7):e1000097. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Standards and guidelines for electronic medical record systems in Kenya. Kenya Ministry of Medical Services, Kenya Ministry of Public Health and Sanitation. 2010. URL: http://guidelines.health.go.ke:8000/media/Standards_and_Guidelines_for_EMR_Systems.pdf [accessed 2023-04-21]
• Kenya standards and guidelines for E-health systems interoperability. Kenya Ministry of Health, AfyaInfo Project. 2014. URL: https://pdf.usaid.gov/pdf_docs/PA00TB2K.pdf [accessed 2023-03-21]
• Health sector ICT standards and guidelines. Kenya Ministry of Health. 2013. URL: https://www.medbox.org/pdf/5e148832db60a2044c2d2895 [accessed 2023-03-21]
• Health information exchange standard operating procedure (SOP) and guideline. Nigeria Federal Ministry of Health. Jul 2020.
• National eHealth strategy 2018-2022. Benin Ministry of Health. 2017.
• The eHealth strategy of botswana 2020-2024. Botswana Ministry of Health. URL: https://ehealth.ub.bw/bhdc/Docs/MOH%20ehealth%20Strategy%20Book%20A4.pdf [accessed 2023-04-22]
• Health sector digital strategy 2016-2020. Burkina Faso Ministry of Health.
• National health informatics development plan of Burundi. Burundi Ministry of Public Health. 2015.
• The 2020-2024 national digital health strategic plan. Cameroon Ministry of Public Health. 2020.
• National eHealth strategy 2017-2021. Comoros Ministry of Health. 2016.
• eHealth strategic plan. Cote d’Ivoire Minister of Health and Public Hygiene. 2011.
• National development plan for health informatics. Democratic Republic of Congo Ministry of Public Health. 2014.
• Kingdom of Swaziland eHealth strategy 2016 - 2020. Kingdom of Swaziland Ministry Of Health. 2016.
• Information revolution strategic plan (2018-2025). Ethiopia Ministry of Health. 2018.
• Strategic master plan of the health information system of the Gabon. Gabon Ministry of Public Health and Population. 2017.
• National e-Health strategy. Ghana Ministry of Health. 2010.
• Kenya national e-Health strategy. Kenya Ministry of Medical Services, Kenya Ministry of Public Health & Sanitation. 2011.
• Kenya national eHealth policy 2016-2030. Kenya Ministry of Health. 2016.
• National strategy - Liberia - 2016-2021. Liberia Ministry of Health. 2016.
• Strategic plan for strengthening the health information system of Madagascar 2018–2022. Madagascar Ministry of Public Health. 2017.
• National digital health strategy 2020-2025. Malawi Ministry of Health. 2020.
• National eHealth policy in Mali. Mali Ministry of Health and Public Hygiene. 2013.
• Health 2015: seamless continuity of care. Mauritius Ministry of Health and Quality of Life. 2015.
• Strategic plan of information system for health 2009-2014. Mozambique Ministry of Health. 2009.
• National eHealth strategy 2019-2023. Niger Ministry of Public Health. 2018.
• National digital health strategy 2021-2025. Nigeria Federal Ministry of Health. 2021.
• National digital health policy. Nigeria Federal Ministry of Health. 2021.
• National digital health strategic plan 2018-2023. Rwanda Ministry of Health. 2018. URL: https://elearning.helinanet.org/mod/resource/view.php?id=890 [accessed 2023-05-09]
• Strategic plan for digital health 2018-2023. Senegal Ministry of Health and Social Action. 2018.
• National digital health strategy 2018-2023. Sierra Leone Ministry of Health and Sanitation, Sierra Leone Ministry of Information and Communication. 2018.
• The national digital health strategy 2019 – 2024. Tanzania Ministry of Health, Community Development, Gender, Elderly and Children. 2019.
• National digital health strategy for South Africa 2019 - 2024. South Africa Department of Health. 2019.
• Strategic plan for the development of eHealth in Togo 2013-2015. Togo Ministry of Health. 2012.
• Uganda national eHealth policy. Uganda Ministry of Health. 2016.
• Uganda national eHealth strategy 2017 - 2021. Uganda Ministry of Health. URL: https://health.go.ug/sites/default/files/National%20e_Health%20Strategy_0.pdf [accessed 2023-05-16]
• National eHealth strategy 2017-2021. Zambia Ministry of Health. 2017.
• Zimbabwe’s E-Health strategy 2012-2017. Ministry of Health and Child Welfare. 2012.
• National eHealth strategy 2021-2025. Namibia Ministry of Health & Social Services. 2021. URL: https://www.scribd.com/document/639371316/eHealth-Strategy-Namibia-2021# [accessed 2023-05-13]
• Health sector ICT policy and strategy. Ghana Ministry of Health. 2005. URL: https://www.moh.gov.gh/wp-content/uploads/2016/02/Health-Sector-ICT-Policy-and-Strategy.pdf [accessed 2023-05-08]
• Adebola OJ. Beyond national digital health strategy: final report of end term evaluation for the National Health ICT Strategic Framework 2015-2020. Nigeria Federal Ministry of Health. May 2021.
• National Health ICT Strategic Framework 2015 - 2020. Nigeria Federal Ministry of Health. 2016. URL: https://www.health.gov.ng/doc/HealthICTStrategicFramework.pdf [accessed 2023-05-16]
• Digital health blueprint. Ethiopia Ministry of Health. 2021. URL: http:/​/repository.​iifphc.org/​bitstream/​handle/​123456789/​1658/​Ethiopian-Digital-Health-Blueprint.​pdf?sequence=1&isAllowed=y [accessed 2023-05-16]
• Kenya health information systems interoperability framework. Kenya Ministry of Health. 2020. URL: https:/​/www.​data4sdgs.org/​sites/​default/​files/​services_files/​Kenya%20Health%20Information%20Systems%20Interoperability%20Framework.​pdf [accessed 2023-05-16]
• National community health digitization strategy 2020-2025. Kenya Ministry of Health, Division of Community Health Services. 2021. URL: https:/​/www.​eahealth.org/​sites/​www.eahealth.org/​files/​content/​attachments/​2021-08-02/​eCHIS-Strategy-2020-2025.​pdf [accessed 2023-05-16]
• Leitner C, Potenziani D. Health information systems interoperability in Liberia. IntraHealth International. 2016. URL: https://elearning.helinanet.org/mod/resource/view.php?id=938 [accessed 2023-05-16]
• Narrative for 2022 national digital health annual operational plan (AOP). Nigeria Federal Ministry of Health. 2022.
• Tanzania digital health investment road map 2017-2023. Tanzania Ministry of Health, Community Development, Gender, Elderly and Children, President’s Office Regional Administration and Local Government. 2017.
• Yu H. Regulation of digital health technologies in the European Union: intended versus actual use. In: Cohen GI, Minssen T, Price II NW, Robertson C, Shachar C, editors. The Future of Medical Device Regulation: Innovation and Protection. Cambridge. Cambridge University Press; Mar 31, 2022;103-114.
• Policy for device software functions and mobile medical applications: guidance for industry and Food and Drug Administration staff. U.S. Food and Drug Administration. 2022. URL: https://www.fda.gov/media/80958/download [accessed 2023-10-10]
• Gordon WJ, Landman A, Zhang H, Bates DW. Beyond validation: getting health apps into clinical practice. NPJ Digit Med. 2020;3:14. [ FREE Full text ] [ CrossRef ] [ Medline ]
• FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs. U.S. Food and Drug Administration. 2018. URL: https:/​/www.​fda.gov/​news-events/​press-announcements/​fda-clears-mobile-medical-app-help-those-opioid-use-disorder-stay-recovery-programs [accessed 2021-01-27]
• Digital maturity model: achieving digital maturity to drive growth. Deloitte. 2018. URL: https:/​/www2.​deloitte.com/​content/​dam/​Deloitte/​global/​Documents/​Technology-Media-Telecommunications/​deloitte-digital-maturity-model.​pdf [accessed 2021-10-20]
• May E. How digital health apps are empowering patients. Deloitte. 2021. URL: https:/​/www2.​deloitte.com/​us/​en/​blog/​health-care-blog/​2021/​how-digital-health-apps-are-empowering-patients.​html [accessed 2023-10-06]
• Guidance: criteria for health app assessment. Public Health England. 2017. URL: https:/​/www.​gov.uk/​government/​publications/​health-app-assessment-criteria/​criteria-for-health-app-assessment [accessed 2023-10-16]
• Clinical risk management standards. National Health Service Digital. 2020. URL: https://digital.nhs.uk/services/clinical-safety/clinical-risk-management-standards [accessed 2023-10-28]
• Report a problem with a medicine or medical device. Gov.uk. URL: https://www.gov.uk/report-problem-medicine-medical-device [accessed 2023-11-07]
• Digital technology assessment criteria for health and social care (DTAC) - Version 1.0. National Health Service X. 2021. URL: https:/​/view.​officeapps.live.com/​op/​view.​aspx?src=https%3A%2F%2Ftransform.​england.​nhs.​uk%2Fmedia%2Fdocuments%2FDTAC_version_1.​0_FINAL_updated_16.​04.​odt&wdOrigin=BROWSELINK [accessed 2023-11-07]
• Data protection impact assessment: NHS login - formerly Citizen Identity. National Health Service Digital. 2022. URL: https://digital.nhs.uk/services/nhs-login/data-protection-impact-assessment [accessed 2023-11-07]
• Risks and data protection impact assessments (DPIAs). Information Commissioner’s Office. URL: https:/​/ico.​org.uk/​for-organisations/​uk-gdpr-guidance-and-resources/​accountability-and-governance/​accountability-framework/​risks-and-data-protection-impact-assessments-dpias/​ [accessed 2023-11-07]
• A guide to good practice for digital and data-driven health technologies. Department of Health and Social Care. 2021. URL: https:/​/www.​gov.uk/​government/​publications/​code-of-conduct-for-data-driven-health-and-care-technology/​initial-code-of-conduct-for-data-driven-health-and-care-technology [accessed 2023-10-30]
• Interoperability in healthcare. Healthcare Information and Management Systems Society (HIMSS). 2023. URL: https://www.himss.org/resources/interoperability-healthcare [accessed 2023-10-17]
• DAPB4020: UK core Fast Healthcare Interoperability Resources (FHIR) release 4 (R4) governance. National Health Service Digital. 2022. URL: https:/​/digital.​nhs.uk/​data-and-information/​information-standards/​information-standards-and-data-collections-including-extractions/​publications-and-notifications/​standards-and-collections/​dapb4020-uk-core-fhir-r4-governance [accessed 2023-10-17]
• Fast Healthcare Interoperability Resources (FHIR). National Health Service Digital. 2022. URL: https://digital.nhs.uk/services/fhir-apis [accessed 2023-10-17]
• FHIR Interoperability Basics: 4 things to know. Health IT Analytics. 2022. URL: https://healthitanalytics.com/news/4-basics-to-know-about-the-role-of-fhir-in-interoperability [accessed 2023-11-07]
• Giordanengo A, Bradway M, Pedersen R, Grøttland A, Hartvigsen G, Årsand E. Integrating data from apps, wearables and personal electronic health record (pEHR) systems with clinicians’ electronic health records (EHR) systems. Int J Integr Care. Nov 09, 2016;16(5):16. [ FREE Full text ] [ CrossRef ]
• A plan for digital health and social care. Department of Health & Social Care. 2022. URL: https:/​/www.​gov.uk/​government/​publications/​a-plan-for-digital-health-and-social-care/​a-plan-for-digital-health-and-social-care [accessed 2022-12-01]
• Ryu B, Kim N, Heo E, Yoo S, Lee K, Hwang H, et al. Impact of an electronic health record-integrated personal health record on patient participation in health care: development and randomized controlled trial of MyHealthKeeper. J Med Internet Res. Dec 07, 2017;19(12):e401. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Winter A, Takabayashi K, Jahn F, Kimura E, Engelbrecht R, Haux R, et al. Quality requirements for electronic health record systems*. A Japanese-German information management perspective. Methods Inf Med. Aug 07, 2017;56(7):e92-e104. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Wachter RM. Making IT work: harnessing the power of health information technology to improve care in England. National Advisory Group on Health Information Technology. 2016. URL: https:/​/assets.​publishing.service.gov.uk/​government/​uploads/​system/​uploads/​attachment_data/​file/​550866/​Wachter_Review_Accessible.​pdf [accessed 2021-07-22]
• Framework on integrated people-centred health services (IPCHS). World Health Organisation. 2023. URL: https:/​/www.​who.int/​teams/​integrated-health-services/​clinical-services-and-systems/​service-organizations-and-integration [accessed 2023-06-05]
• Ibeneme S, Karamagi H, Muneene D, Goswami K, Chisaka N, Okeibunor J. Strengthening health systems using innovative digital health technologies in Africa. Front Digit Health. 2022;4:854339. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Ibeneme S, Ukor N, Ongom M, Dasa T, Muneene D, Okeibunor J. Strengthening capacities among digital health leaders for the development and implementation of national digital health programs in Nigeria. BMC Proc. 2020;14(Suppl 10):9. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Delivering safe digital health. Organisation for the Review of Care and Health Apps. URL: https://orchahealth.com/ [accessed 2023-10-22]
• Mamuye AL, Yilma TM, Abdulwahab A, Broomhead S, Zondo P, Kyeng M, et al. Health information exchange policy and standards for digital health systems in Africa: a systematic review. PLOS Digit Health. Oct 2022;1(10):e0000118. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Digital health platform handbook: Building a digital information infrastructure (infostructure) for health. World Health Organization, International Telecommunication Union. 2022. URL: https://www.itu.int/dms_pub/itu-d/opb/str/D-STR-E_HEALTH.10-2020-PDF-E.pdf [accessed 2021-05-22]
• Framework for involving patients in patient safety 2021. National Health Service England. 2021. URL: https://www.england.nhs.uk/patient-safety/framework-for-involving-patients-in-patient-safety/ [accessed 2023-03-23]
• Olesch A. Towards harmonised EU landscape for digital health: summary of the roundtable discussions in selected EIT Health InnoStars countries. EIT Health InnoStars. Jan 2023. URL: https://eithealth.eu/wp-content/uploads/2023/02/EIT_Health_DiGA_report_Jan2023.pdf [accessed 2023-10-10]
• Grieb J, Tschammler D, Färber C, Woitz S. Digital health laws and regulations germany. Global Legal Group. 2023. URL: https://iclg.com/practice-areas/digital-health-laws-and-regulations/germany [accessed 2023-11-03]
• Human regulatory: medical devices. European Medicines Agency. URL: https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices [accessed 2023-10-12]
• Strengthening the capacity for regulation of medical products in the African region. World Health Organization Regional Office for Africa. 2013. URL: https://iris.who.int/bitstream/handle/10665/94308/AFR_RC63_7.pdf?sequence=1 [accessed 2023-10-17]
• Ncube BM, Dube A, Ward K. Establishment of the African Medicines Agency: progress, challenges and regulatory readiness. J Pharm Policy Pract. Mar 08, 2021;14(1):29. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Post market surveillance system. European Union Medical Device Regulation. 2023. URL: https://eumdr.com/post-market-surveillance-system/ [accessed 2023-10-31]
• Dayal R. Effective post-market surveillance for medical devices: An essential part of medical devices regulation (MDR). Capgemini. 2020. URL: https:/​/www.​capgemini.com/​insights/​expert-perspectives/​effective-post-market-surveillance-for-medical-devices-an-essential-part-of-mdr/​ [accessed 2023-10-31]
• NHS app library reaches 70 apps in honour of the NHS birthday. Northampton General Hospital NHS Trust. 2018. URL: https:/​/www.​northamptongeneral.nhs.uk/​News/​News-Archive/​2018/​NHS-App-Library-reaches-70-apps-in-honour-of-the-NHS-birthday.​aspx [accessed 2023-09-21]
• Developers invited to add to NHS apps library. National Health Service Digital. 2018. URL: https://digital.nhs.uk/news/2018/developers-invited-to-add-to-nhs-apps-library [accessed 2023-09-22]
• The NHS apps library has closed. National Health Service Digital. 2021. URL: https:/​/digital.​nhs.uk/​services/​nhs-apps-library#:~:text=The%20NHS%20Apps%20Library%20was%20decommissioned%20in%20December%202021.​&text=Further%20information%20can%20be%20found%20on%20the%20NHS.​UK%20website [accessed 2023-09-22]
• Larsen ME, Huckvale K, Nicholas J, Torous J, Birrell L, Li E, et al. Using science to sell apps: evaluation of mental health app store quality claims. NPJ Digit Med. 2019;2:18. [ FREE Full text ] [ CrossRef ] [ Medline ]
• About the NHS app. National Health Service. Dec 4, 2023. URL: https://www.nhs.uk/nhs-app/about-the-nhs-app/ [accessed 2023-09-22]
• Scope of registration: regulated activities. Care Quality Commission. 2022. URL: https://www.cqc.org.uk/guidance-providers/scope-registration-regulated-activities [accessed 2023-11-05]
• Distributing great apps into health and care services across the world. Organisation for the Review of Care and Health Apps. 2020. URL: https://orchahealth.com/wp-content/uploads/2020/12/Health-and-Care-1.pdf [accessed 2023-10-09]
• Our founder, our story and our values: we exist to make digital health healthy. Organisation for the Review of Care and Health Apps. URL: https://orchahealth.com/about-us/ [accessed 2023-10-09]
• Health app library: empower your community with safe access to health apps and digital health products. Organisation for the Review of Care and Health Apps. URL: https:/​/orchahealth.​com/​our-products/​health-app-library/​#:~:text=A%20Health%20App%20Library%20is,on%20the%20Health%20App%20Library [accessed 2023-10-09]
• Digital technology assessment criteria (DTAC). National Health Service X. URL: https://www.nhsx.nhs.uk/key-tools-and-info/digital-technology-assessment-criteria-dtac/ [accessed 2023-10-09]
• Evidence standards framework (ESF) for digital health technologies. National Institute for Health and Care Excellence. 2023. URL: https:/​/www.​nice.org.uk/​about/​what-we-do/​our-programmes/​evidence-standards-framework-for-digital-health-technologies [accessed 2023-10-08]
• Tsang L, Kerr-Peterson H. UK NICE updates its evidence standards framework for data-driven digital health technologies. Ropes & Gray. 2022. URL: https:/​/www.​ropesgray.com/​en/​insights/​alerts/​2022/​10/​uk-nice-updates-its-evidence-standards-framework-for-data-driven-digital-health-technologies [accessed 2023-10-09]
• Guidance: medical device stand-alone software including apps (including IVDMDs). Medicines and healthcare products regulatory agency. 2023. URL: https:/​/assets.​publishing.service.gov.uk/​government/​uploads/​system/​uploads/​attachment_data/​file/​1168485/​Medical_device_stand-alone_software_including_apps__including_IVDMDs_.​pdf [accessed 2023-10-09]
• Digital therapeutics in the United Kingdom. Digital Therapeutics Alliance. 2021. URL: https://dtxalliance.org/wp-content/uploads/2021/06/DTA_DTx-Overview_UK.pdf [accessed 2023-10-09]
• Transforming global healthcare by advancing digital therapeutics. Digital Therapeutics Alliance. 2023. URL: https://dtxalliance.org/ [accessed 2023-10-10]
• International Organization for Standardization (ISO) digital therapeutic definition. Digital Therapeutic Alliance. Jun 2023. URL: https://dtxalliance.org/wp-content/uploads/2023/06/DTA_FS_ISO-Definition.pdf [accessed 2023-10-09]
• Ndomondo-Sigonda M, Miot J, Naidoo S, Dodoo A, Kaale E. Medicines regulation in Africa: current state and opportunities. Pharmaceut Med. 2017;31(6):383-397. [ FREE Full text ] [ CrossRef ] [ Medline ]
• Chinele J. East Africa shows solid support for African Medicines Agency treaty. Health Policy Watch. Aug 16, 2023. URL: https://healthpolicy-watch.news/east-africa-shows-solid-support-for-african-medicines-agency-treaty/ [accessed 2023-10-09]
• Treaty for the establishment of the African Medicines Agency 2019. African Union. 2019. URL: https://au.int/sites/default/files/treaties/36892-treaty-0069_-_ama_treaty_e.pdf [accessed 2023-10-17]
• European Medicines Agency: about us. European Medicines Agency. Mar 1, 2023. URL: https://www.ema.europa.eu/en/documents/other/about-us-european-medicines-agency-ema_en.pdf [accessed 2023-10-18]
• Bryson JM. What to do when stakeholders matter. Public Adm Rev. Mar 2004;6(1):21-53. [ FREE Full text ] [ CrossRef ]
• Iyawa G, Herselman M, Botha A. Potential stakeholders and perceived benefits of a digital health innovation ecosystem for the Namibian context. Procedia Computer Science. 2017;121:431-438. [ CrossRef ]
• Ferretti V. From stakeholders analysis to cognitive mapping and multi-attribute value theory: an integrated approach for policy support. European Journal of Operational Research. Sep 2016;253(2):524-541. [ CrossRef ]
• Brugha R, Varvasovszky Z. Stakeholder analysis: a review. Health Policy Plan. Sep 2000;15(3):239-246. [ CrossRef ] [ Medline ]
• Schmeer K. Guidelines for conducting a stakeholder analysis 1999. Partnerships for Health Reform, Abt Associates. 1999. URL: https://www.ktecop.ca/wordpress/wp-content/uploads/guidelines-stakeholder-analysis-PHR-1999.pdf [accessed 2023-10-17]
• Gilmour J, Beilin R. Stakeholder mapping for effective risk assessment and communication. Australian Centre of Excellence for Risk Analysis, University of Melbourne. Apr 2007. URL: https://cebra.unimelb.edu.au/__data/assets/pdf_file/0006/2220990/gilmour0609.pdf [accessed 2023-10-17]
• Quality, service improvement and redesign tools: stakeholder analysis. National Health Service England, National Health Service Improvement. 2022. URL: https://www.england.nhs.uk/wp-content/uploads/2022/02/qsir-stakeholder-analysis.pdf [accessed 2023-10-20]
• Craven MP, Lang AR, Martin JL. Developing mHealth apps with researchers: multi-stakeholder design considerations. Springer; 2014. Presented at: Third International Conference, DUXU 2014, held as a part of HCI International; June 22-27, 2014;15-24; Heraklion, Greece. URL: https://doi.org/10.1007/978-3-319-07635-5_2 [ CrossRef ]
• How to encourage stakeholder participation. SustaiNet Software International. URL: https://sustainet.com/how-to-encourage-stakeholder-participation/ [accessed 2023-10-20]
• Stakeholder engagement. Organisation for Economic Cooperation and Development. URL: https:/​/www.​oecd.org/​governance/​better-international-rulemaking/​compendium/​keyprinciples/​stakeholderengagement.​htm [accessed 2023-10-20]
• Microsoft Copilot in Bing. Microsoft. URL: https://www.bing.com/chat?form=NTPCHB [accessed 2023-03-15]

Abbreviations

Edited by A Mavragani; submitted 19.05.23; peer-reviewed by N O'Brien, A Essén; comments to author 07.09.23; revised version received 08.12.23; accepted 23.02.24; published 11.04.24.

©Benard Ayaka Bene, Sunny Ibeneme, Kayode Philip Fadahunsi, Bala Isa Harri, Nkiruka Ukor, Nikolaos Mastellos, Azeem Majeed, Josip Car. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 11.04.2024.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.

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What Cass review says about surge in children seeking gender services

Report finds particularly complex factors may explain surge in birth-registered females referred to NHS Gids

In 2009 the NHS’s gender identity development service (Gids) saw fewer than 50 children a year. Since then, demand increased a hundredfold, with more than 5,000 seeking help in 2021-22.

In her review of gender services , Dr Hilary Cass said there had been a “dramatic increase” in presentations to gender clinics in the last decade, in particular by birth-registered females. In 2009, Gids treated 15 girls. By 2016, that figure had risen to 1,071.

“There has been a significant change in the population of young people over the last 10 to 15 years,” Cass told BBC Radio 4’s Today programme on Wednesday.

“So about 15 years ago, the service was seeing perhaps 50 predominantly birth registered boys in childhood. And over the last 10 years or so it’s switched to over 3,000 young people, and it’s mainly birth-registered girls presenting in early teens … often with quite complex additional problems.”

There is no single explanation for the increase in prevalence of gender incongruence or the specific rise in birth-registered females referred to Gids, her review concluded.

But it says various factors may explain the increase in predominantly birth-registered females presenting to gender services in early adolescence:

Social media and the internet

Generation Z and Generation Alpha (those born since 2010) have grown up with “unprecedented” online lives, the report says. This has huge advantages, but also brings risks and challenges.

Greater access to the internet has given children and young people learning resources “but it has also made them vulnerable to new dangers”, according to the review.

“Biology hasn’t changed and adult biology hasn’t changed in the last few years,” Cass said this week. “So it’s not that that’s changed things.

“I don’t think that young people today are being exposed to more abuse, or trauma or so on, than previous generations. We do have to think very seriously about the impact of social media.”

The report says girls spend more hours using social media than boys. A study cited by Cass found 43% of girls used social media for three or more hours a day, compared with 22% of boys.

A systematic review highlighted by the Cass report found that use of social media was associated with body image concerns. Numerous other studies cited by the report implicate smartphone and social media use in mental distress and suicidality among young people, particularly girls.

All showed a clear dose-response relationship: the more hours spent online, the greater the effect.

Peer and socio-cultural influence

The report suggests that although the impact of societal influences on a child’s gender expression remains unclear, it’s clear that the influences of a child’s peers are “very powerful during adolescence”.

Although the report does not specifically state that girls are affected by social and cultural influences, such as peer pressure, more than boys, and so too their gender expression, other evidence has suggested this is the case.

Several studies have implied that girls are more affected by peer pressure than boys, and are more likely to develop a negative body image during adolescence.

Another societal influence that the report references as possibly having an impact on a young person’s gender expression includes information on gender dysmorphia and gender expression found online.

More specifically, a focus group of gender-questioning young people and their parents who spoke to the review said that they often found online information “that describes normal adolescent discomfort as a possible sign of being trans and that particular influencers have had a substantial impact on their child’s beliefs and understanding of their gender”.

One gender-questioning young person is quoted in the report affirming this view, saying a “lot of trans people make YouTube videos, which I think is a major informational source for a lot of people, and that’s mainly where I get my information from, not so much professional services”.

The report also stated that according to another focus group of gender-questioning young people, they often found it difficult to find “trusted sources of information, favouring lived experience social media accounts over mainstream news outlets”.

Greater societal acceptance of transgender identities has allowed young people to come out easily, the review found. It suggests that the increased numbers now reflect the true prevalence of gender incongruence in society.

Dangerous online influencers

Cass said her review team received reports of gender-questioning children being urged to hide things from their parents. “We haven’t done a comprehensive search but certainly when we were told about particular influencers, I followed some of those up,” Cass said. “Some of them give them very unbalanced information.

“And some [young people] were told that parents would not understand, so that they had to actively separate from their parents or distance their parents. All the evidence shows that that family support is really key to people’s wellbeing. So there was really some dangerous influencing going on.”

Cass says the influencers “are legion” but declined to identify any specially.

Mental health

The striking increase in young people presenting with gender dysphoria should be seen within the context of increasing rates of poor mental health and emotional distress among the broader adolescent population, particularly among girls, the Cass report found.

There has been a substantial increase in rates of mental health problems in children and young people, with increased anxiety and depression being most evident in teenage girls, UK national surveys between 1999 and 2017 show.

The Cass review found that there was a “marked increase” in young women aged between 16 and 24 presenting with anxiety, depression and self-harm. Some conditions – for example, eating disorders – have increased more than others, particularly in girls and young women.

Studies of rates of self-harm have shown similar increases. For example, the report says there was an almost 70% increase in girls aged between 13 and 16 presenting with self-harm. This was not seen in boys, the review noted.

“The increase in presentations to gender clinics has to some degree paralleled this deterioration in child and adolescent mental health,” the report says. “Mental health problems have risen in both boys and girls, but have been most striking in girls and young women.”

Girls were also more likely to have low self-esteem (12.8% versus 8.9% of boys), according to a study cited by the Cass review. They were also more likely to be unhappy with their appearance (15.4% versus 11.8% of boys).

Changes in concepts of gender and sexuality

The report states that the relationship between sexuality and gender identity is “complex and contested”, and that although a trans identity does not necessarily determine a person’s sexuality, it was “important to consider the relationship between sexual identity and gender identity given that sexuality contributes to a person’s sense of identity, and both may be fluid during adolescence”.

The report cites a 2016 research paper from Gids that looked at sexual orientation in 57% (97) of a clinic sample of patients over 12 years of age for whom this information was available.

Of the birth-registered females, 68% were attracted to females, 21% were bisexual, 9% were attracted to males and 2% were asexual. Of the birth-registered males, 42% were attracted to males, 39% were bisexual and 19% were attracted to females.

The report goes on to say that it is “common in adolescence to experience same-sex attraction and not to conform to gender stereotypes. In making sense of these feelings young people are now having to navigate an increasingly complex interplay between sex and gender.”

On the relationship between sexual orientation and gender identity, the review concludes that it “is an area that warrants better exploration and understanding”.

The report also stated that it had received several reports from parents of birth-registered females “that their child had been through a period of trans identification before recognising that they were cisgender same-sex attracted”.

• Transgender
• Children's health
• Young people

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