With hundreds of thousands of health apps on the market today, choosing the right one can be confusing for patients. Countries all over the world are looking to help their citizens navigate the process. Governments are increasingly moving towards a centralized approach for digital health regulation and reimbursement, according to a new article in Nature. 

"We found that most approaches aim for centralized pipelines for health app approvals, although some countries are adding decentralized elements," authors of the article wrote. "While the countries studied are taking diverse paths, there is nevertheless broad, international convergence in terms of requirements in the areas of transparency, health content, interoperability, and privacy and security." 

The article looked at digital health approaches in nine countries including the U.S., Sweden, Norway, Denmark, Netherlands, Belgium, Germany, England and Singapore. 

Researchers found that Belgium and Germany led the pack on "operationalizing and implementing their market access and reimbursement approval framework of medical apps."

The article outlined "bottlenecks" as a potential issue for a centralized regulatory framework, however authors reported that countries most likely will have a combination of a centralized regulatory body for more clinical apps, and a more "market-based evaluation" for consumer apps.  

Another trend is that countries are looking towards offering apps through different channels, such as national portals or through a directory of apps. Privacy, interoperability and usability were also some of the main priorities of the countries in the research. 

"Our analyses of the relevant policies identified challenges in areas such as reimbursement, safety and privacy and suggest that more regulatory work is needed in the areas of operationalization, implementation and international transferability of approvals," according to the authors. "Cross-national efforts are needed around regulation and for countries to realize the benefits of these technologies."

WHY IT MATTERS 

During the COVID-19 pandemic, digital health adoption soared. However, there are still many questions about digital health regulation, reimbursement and long-term adoption. 

"In various areas of healthcare, digital applications hold great promise for expanding access to services, substituting for and/or complementing existing standards of care, and creating value and convenience for patients," researchers wrote.

"Yet globally, healthcare systems are struggling with how to incorporate and leverage the accelerating pace of innovation and commercialization of new digital tools that could potentially improve the treatment of illness and maintain health.

THE LARGER TREND

In the U.S., the FDA has been looking to evolve its framework for digital health regulation with the FDA PreCert program.  PreCert program is different from previous FDA regulatory ventures, because it will focus not on particular products but on firms and developers.

But the U.S. isn't the only country creating new guidelines. Last week at HIMSS22,  Dr. Brigitte Séroussi, director of projects in charge of digital health ethics at the eHealth Delegation of the French Ministry of Health, said that France was putting ethics at the heart of its digital health strategy.

The government included environmental impact, usability and privacy as metrics for evaluating digital initiatives. The French government is now sharing their methods with other members of the E.U.