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.

MRC Provides Feedback on Drafted FDA Regulations for Medical Mobile Apps

by Holly Shoemaker

In a previous blog, I discussed how the Food and Drug Administration (FDA) proposed regulating medical mobile apps used as devices. I continue to follow the topic and will post follow-up blogs related to the feedback received. When possible, I will devote a blog to each organization who commented on the drafted guidelines. This blog focuses on the feedback provided by the mHealth Regulatory Coalition (MRC), a grouped formed in 2010 to focus on defining what medical mobile apps require regulation. The coalition is made up of telecommunications professionals, cell phone manufacturers, semiconductor companies and medical devices companies.

Summary of MRC Feedback

The organization provided four main areas of concern. Those include:

• Clarity – MRC said the drafted regulations were too broad and could result in too many regulations of medical mobile apps. It suggests the FDA also identify specific products it does not plan to regulate.
• Accessory rule – MRC takes the stance that an accessory that has the potential for use as a medical device still falls into the category of using an app as a device. The organization proposes that the FDA develop new regulations for these types of products.
• Roles and responsibilities – MRC would like the FDA to reconsider who is responsible for which regulatory activities during the pre- and post-market phases.
  
• Software regulations – MRC would like the FDA to ease its proposed software regulations. The organization said that its drafted guidelines could create a high burden for developers. To ease the burden, MRC recommends implementing a standard set of design principles.

In addition to making improvements in the above areas, MRC wants the guidelines to help innovate healthcare delivery, reduce healthcare costs and stimulate jobs.

Concluding Thoughts

MRC makes valid suggestions. The organization’s comments take into consideration the needs of developers, healthcare workers and patients. I will continue to monitor for responses from other agencies, developers, consumers and the FDA.