As many of the readers of this blog know by now, the FDA draft guidance on mobile medical apps was released on July 19, 2011. While there are those who believe that FDA involvement in the regulation of healthcare apps is an ‘assault on mobile technologies’ there are many reasons for which this oversight is needed as previously stated by this author The draft guidance was put on hold in the US Senate as part of a passed amendment of another bill. So here we sit, with technology developers and companies involved in mHealth worldwide waiting for the FDA to act. It is, in essence being held hostage in a political war on Capitol Hill. It is estimated that the issue of the guidance document will not be resolved until 2014. What can be done in the meantime?
1. The Society for Participatory Medicine “is a cooperative model of health care that encourages and expects active involvement by all connected parties (patients, caregivers, healthcare professionals, etc.) as integral to the full continuum of care.” Among other things, the Society “aims to advance the understanding of physicians and other professionals in the importance of well-informed, empowered and engaged patients making informed decisions about their care and treatment.” There is no other organization I can think of that understands the potential of mobile health technologies in empowering patients. I would look for the Society to formulate a statement to lawmakers highlighting the importance of mobile health apps, the imperative to depoliticize this issue.
2. Social media. The Twitterverse has been utilized in natural and political disasters around the world. Social media is a recognized way of mobilizing (no pun intended) people for various causes. I can think of no greater cause at this time than letting others, including legislators how politically dangerous and irresponsible it is for the Congress to hold the health of its represented citizens literally hostage in a game of political football. Unfortunately we have seen this gamesmanship with other important healthcare issues. A social media campaign is appropriate for a grass-roots campaign by all stakeholders.
3. Medical Students. I single out medical students because they are members of ‘Generation C’. They have been digitally connected for their whole adult life. They are realizing the importance of medical apps more than their mentors. Young physicians adopt mobile apps in their practice at a far greater rate than older ones. They are part of the future of healthcare and need to advocate for tools they already know will be important to them in treating patients.
4. Mobile Health tech companies. Now that large telecom companies, insurers and others are realizing the value of mobile health technologies, they must use their political clout to help unglue the FDA guidance document from other legislation, or get it glued to something else which will pass quickly (or heaven forbid have it presented as a standalone piece of legislation).
5. Non-legislative political players. I sent a letter to Mary Jo Deering, the Senior Policy Advisor at the US HHS about this issue. Getting people in these types of positions involved is important. They are both appreciative of the issue at hand, and are inside the beltway. Both the present Secretary of HHS, Kathleen Sebelius, and the Surgeon General, vice Admiral Regina Benjamin have been speakers at major conferences involving mHealth. Dr. Benjamin kicked off her app challenge at the mHealth Summit. Surely they cannot ignore this issue. Let’s have them hear about it more from us.