FDA Guidelines on Approving mHealth Apps

February 20, 2014 | Reply More

Rob prefered photos Web blogWith all that is going on with the Affordable Care Act, a lot of the talk among attendees at the mHealth Summit was centered on the role of government in moving mHealth forward.

The final guidance on mobile health apps was deregulatory insofar as it clarified that FDA would not utilize the full possible extent of its regulatory authority.  The guidance also explained the risk-based rationale for its approach, provided specific examples and promised to continue to add to the list.  Agency staff have also committed to a national “road show” to help educate the community.

However, two events since the final guidance was issued have moved to the top of the FDA headlines.

First, a bipartisan group in Congress has embraced recommendations from a trade group and a Washington D.C.-based think tank to create a new category of unregulated software that could, under current law, be regulated as a “medical device.”  Given the importance of software in healthcare, both on a stand-alone basis and as the operating instructions for complex medical devices and systems, this proposal is very consequential.

Second, the FDA recently issued a “Warning Letter” instructing B2C genetics company, 23andMe, to discontinue marketing its service to consumers.  This action will undoubtedly add to the level of Congressional scrutiny of the FDA.  It will be difficult to separate the politically and ideologically motivated activity out, but there are very significant issues that must be addressed.

Chief among them, in my opinion, is the need to spell out the legal relationship among patients, providers and the entire medical industry so that promising tech-enabled approaches to diagnosing, treating and preventing disease can be adopted more quickly within an environment where providers are paid for (good) outcomes and the medical industry is transparent about the risks and outcomes associated with their products.  This is how the consumer sector works.  As a result, consumer products and services generally become both better and cheaper over time.  In health care, old technologies are frozen in time through vendors’ skillful management of regulatory and reimbursement policies for the mutual benefit of vendors and providers.  High prices, old technology and business models based on delivering “sick care” not “health care” are hallmarks of health care today.

Things to think about:

  • The role of mobile operators in making mHealth a reality (spectrum, coverage, quality)
    • Mobile operators’ continuous improvement of coverage and quality should be sufficient to provide the capacity needed for well-designed mobile health platforms which deal with trivial amounts of data compared with entertainment content.  They may run into prioritization issues if claims about continuous connectivity for life-critical functions (e.g. “an ICU at home”) but this type of service is not central to mobile and even connected health.
  • Why the new FCC chairman should focus on supporting mHealth — and what he can do
    • The only computer that many of the medically underserved and poorest Americans have is a mobile phone.  For many, the phone is also their only “address.”  Thus, mobile phones are critical to their access to all information and services including health promotion and health care services.  Hence, the FCC should develop policies that enhance the ability of the poor to have access to smartphones that are served by 3G and 4G networks.
  • IT issues associated with Obamacare (ACA) – what went wrong and why it impacts all involved
    • What went wrong?  Really bad execution in a really difficult environment including continuous opposition in Congress and active opposition from Governors who put their personal ideology ahead of the interests and needs of their (poor and sick) citizens.  Why is it impactful?  We are not talking about the real issues and if the rollout fails in half the states it will delay our coming to grips with two of the most important challenges facing the US – (1) we waste too much of our resources on health care that is accessible only to the rich, the well insured and the famous, and yet (2) we keep the unemployed, the poor and anyone whose job is at risk in a state of anxiety about their future access to necessary medical services.  This is bad for all of society, which needs a continuing supply of well-educated, healthy and productive workers and customers.
  • Are we falling behind other countries in using mHealth to deliver quality services and lower costs to those who don’t have access today?
    • I actually think we are ahead of most other countries although I have not researched data to support a confident opinion.  My recent week in Europe suggests that the U.S. will be the first major market for mobile health.
  • Could broadly available mHealth deliver the benefits promised by the ACA?
    • No!  The principal benefits of the ACA will come from changes to the payment model for health care (from transaction to outcomes based).  mHealth technologies and services are resources that will be used by a rational health care provider once the governmental and private “compensation system” are fixed.

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