HIMSS Provides Recommendations on FDA Draft to Regulate Medical Mobile Apps

by Holly Shoemaker

In my previous blog, http://myuniversalapps.blogspot.com/2011/12/mrc-provides-feedback-on-drafted-fda.html, I summarized the feedback provided by mHealth Regulator Coalition (MRC) regarding medical mobile apps used as devices. Another group submitted its feedback to the Food and Drug Administration (FDA). On October 19, 2011 (the deadline set by the FDA for public comments), Healthcare Information & Management Systems Society (HIMSS), a not-for-profit group that provides leadership and advice on IT issues related to healthcare, made its suggestions regarding the FDA draft.

Summary of HIMSS Feedback

The organization had three main areas of concern. Those include:

• Education – HIMSS let the FDA know that it wants the agency to “use everyday opportunities” to educate health systems, hospitals, providers and developers on current and future regulations. HIMSS sees this as an area of focus because many health systems and developers design their own mobile medical apps. At this time, they do not have experience being regulated by the FDA. Therefore, the FDA will need to educate and communicate a uniform set of standards to follow.
• Separate draft for some areas – HIMSS comments show the need for the FDA to review general clinical decision support (CDS) applications and how they function. The organization wants special attention paid to any CDS used as an extension of existing health records.
• Software assurance – HIMSS would like the FDA to consider its suggestions when it defines software assurance. In particular, the non-profit wants the FDA to understand the stages of software development.

Concluding Thoughts

These recommendations show the importance of education, protecting patient information and ensuring that the regulations support best practices. These comments also align with some of the recommendations from MRC.