Multinational Health App Policy Landscape: Towards a Regulatory Consensus on Digital Health


Due to its enormous potential for benefits, harms and costs, healthcare is among the most regulated industries in the world. But with the rise of smartphones, an explosion of direct-to-consumer mobile health apps has challenged the role of centralized gatekeepers. As interest in health apps continues to grow, national regulators have turned to strategies to protect consumers from apps that mine and sell health data, recommend unsafe practices or don’t work at all. just not as advertised. To characterize the current state and prospects of these efforts, Essén and colleagues map the emerging national policy landscape on health apps and raise several considerations for cross-border collaboration. Strategies to increase transparency, organize app markets, and monitor existing apps are needed to ensure that the global wave of new digital health tools delivers on its promise to improve health at scale.

In 2020, more than 91,000 digital health apps were launched in app stores, an average of 250 new apps per day1. Meanwhile, investors poured $24 billion into the growing digital health market1. Although consumer health apps are often associated with wellness and fitness apps, apps targeting specific health issues, including mental health, diabetes and cardiovascular disease, now account for half of widely used applications.1. This expanded role of medical benefits comes with privacy concerns2 and the potential for harm3. When interest outweighs evidence4, principles-based frameworks and policies are needed for effective management. Centralized review and accreditation programs would allow clinicians to recommend or prescribe interventions, payers to favor value-based programs, and patients to verify the quality and risks of applications. In their recent article, Essén et al.5 Systematically document national-level policies for mHealth applications to analyze their regulatory context, assessment processes and future directions.

The authors reviewed national health care reports, legislation, published standards, and interviews with experts from nine developed countries in Europe, North America, and Asia. Their analysis revealed a patchwork of programs at varying levels of maturity. More advanced programs include the Fast-Track process in Germany and the mHealthBelgium framework in Belgium, which provide centralized pathways for market access and reimbursement approval. Emerging programs include the Digital Technology Assessment Criteria (DTAC) in England and the Software Pre-Certification (Pre-Cert) pilot program in the United States, which will inform future regulatory models. Less centralized programs include the Swedish Accreditation Agency, which certifies third-party organizations to assess applications based on common criteria. In most other countries, regulatory policy is split between regional recommendations requiring consolidation, consistent with trends in previous studies6. Of those interviewed involved in developing frameworks, most anticipate continued progress toward centralized repositories of approved applications and platform-based curation of Market Access.

Digital health is an amorphous and rapidly evolving space that presents several challenges for traditional regulatory frameworks. These include the sheer number of apps available, their instant global reach, and the rapid changes enabled by software updates.7. Despite these unique attributes, lessons learned from other regulatory strategies can be useful. For example, labels inspired by “nutrition facts” for health applications, such as the model of the International Organization for Standardization (ISO)8can increase transparency in privacy, security and efficiency9. Centralized curation of a user-friendly app marketplace, similar to the health insurance marketplace created by the Affordable Care Act, can allow consumers to compare and evaluate competing optionsten. Risk-based post-marketing surveillance, increasingly practiced as part of drug safety monitoring, may also offer a scalable strategy. An analysis of health apps in the Google Play Store showed that the top 1% of apps account for >80% of downloads, while the bottom 80% generate less than 1% of downloads.1. This bias suggests that post-market evaluation remains feasible despite the sheer multitude of health apps, if agencies can target the most popular and risky services.

Commercial entities can also help organize the proliferation of new digital health products. Full-featured apps like Apple Health consolidate information from health records and third-party apps into a single, secure, interoperable location. Companies like the Organization for the Review of Healthcare Apps (ORCHA) help governments gain accreditation, help app developers meet compliance standards, and organize digital healthcare services for patients. and providers. Some, like Xealth, go even further by bundling compatible digital services into a single platform marketed to vendors. Although less scalable than direct-to-consumer models, commercial intermediaries offer innovative alternatives that can integrate more easily into existing care pathways and systems.

Implementing and standardizing any strategy will require coordination among multiple stakeholders, including regulators, app developers, payers, and vendors. But with the right incentives and safeguards, a vision is emerging for the future of mobile health apps. Clinicians and patients could view lists of approved apps that are data-backed, privacy-certified, covered by their insurance, and interoperable with their electronic health record. Prompt software updates could implement new guidelines, fix software errors, and respond to changes in behavior. Cross-border quality control agreements could build trust as these apps are rolled out around the world. With an eye on this future, Essén et al. offers a comprehensive review of the current state of health app policy and its progressive progress towards an international consensus. As values ​​are codified in frameworks and frameworks translated into legislation, we believe that the continued rise of health apps can be effectively guided towards its potential to deliver patient-centered, technology-enabled and evidence-based care. value.


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First draft by JAD Critical reviews by KPV, MMR and JCK All authors approved the final draft.

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Correspondence to James A. Diao.

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JCK is the editor of npj Digital Medicine. JAD was formerly employed by Apple, Inc. The other authors declare no competing interests.

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Diao, JA, Venkatesh, KP, Raza, MM et al. Multinational Health App Policy Landscape: Towards a Regulatory Consensus on Digital Health.
npd Digit. Med. 5, 61 (2022).

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