Navigating the digital health landscape: a comparative study of health app policies across nine countries
Introduction: the promise and challenge of health apps
Digital health applications hold immense potential for expanding access to healthcare services, improving standards of care, and enhancing patient convenience. However, the sheer number of health apps available in the commercial tech sector can overwhelm clinicians, patients, and payers. The challenge lies in identifying safe and effective apps to generate the most health benefits and guide payer coverage decisions.
Methodology: a comparative study
The study compared the national policy approaches for health apps in nine countries with well-developed healthcare and regulatory systems. The researchers used secondary data, reviewed policy and regulatory documents, and conducted interviews with key individuals and experts in digital health policy.
Key findings: commonalities and differences
- Centralized Pipelines for Health App Approvals: Most countries aim for centralized pipelines for health app approvals, although some incorporate decentralized elements.
- Transparency, Health Content, Interoperability, and Privacy: There is broad international convergence regarding requirements in these areas. However, the vast number of apps on the market presents a challenge for clinicians and patients.
- Challenges in Reimbursement, Safety, and Privacy: The study identified challenges in areas such as reimbursement, safety, and privacy, suggesting that more regulatory work is needed in the areas of operationalization, implementation, and international transferability of approvals.
Conclusion: the need for international collaboration
The study concludes that while countries are taking diverse paths, there is a need for international collaboration in the regulation of health apps. Cross-national efforts are required to realize these technologies' benefits and ensure the safe and effective use of health apps.
Meet the researchers
This comprehensive study was conducted by a team of researchers from various institutions across the globe:
- Anna Essén, House of Innovation, Stockholm School of Economics
- (See article for information about other researchers)
