A Digital Health Q&A with FDA's Bakul Patel

A top CDRH official answers our questions on pressing issues in digital health regulation at FDA.

Interoperability, mobile medical apps, and digital health are all big buzz words in healthcare, and innovators are closely watching how regulation in this area develops. As associate director for digital health at CDRH, Bakul Patel is at the center of this rapidly-changing area. A frequent writer for FDA's blog, FDA Voice, Patel has been a leader in explaining the agency's regulations and guidance documents to industry.

Recently, Patel took time out of his busy schedule to answer a few of our questions about digital health regulation at FDA. Read on for his responses via e-mail, below. For more from Patel, hear him speak at the MD&M East Conference in New York City, June 14-16.

MD+DI: Earlier this year, FDA released draft guidance on interoperable medical devices. Some believe that access to EHR data remains a stumbling block for designing interoperable medical devices. What are your thoughts on this?

Bakul Patel: The FDA draft guidance on interoperability calls for companies to openly share information that can lead to improved interoperability and in turn, improve patient care, reduce errors and adverse events, and lower costs. While the guidance document and the FDA's purview in this regard fall on the information coming in and out of a medical device and not the EHR itself, we do encourage device makers and EHR companies to work open and collaboratively--and with patient privacy in mind--to ensure that device interoperability is safe and effective. For interoperability between devices and between devices and EHRs to work, cooperation across the sector will be needed.

However, the draft guidance should be considered along with other efforts at the FDA and within the Department of Health and Human Services (HHS).  The FDA, in coordination with the Office of the National Coordinator for Health Information Technology (ONC), Centers for Medicare and Medicaid Services, National Institutes of Health, Office of Civil Rights (OCR) and other HHS and Federal partners, has been collaborating with hospitals, health care providers, manufacturers, standards development organizations and other interested parties to promote medical device interoperability because it helps patients.  

HHS' interoperability efforts can be grouped around three long term objectives: (1) use of common standards (2) culture change around access to information, particularly by combating information blocking, and (3) building the business case for interoperability, including through regulatory and payment reform efforts. 

HHS is encouraging all health technology stakeholders to move toward common standards that will promote interoperability.

MD+DI: It's been more than a year since FDA issued guidance on mobile medical applications. What is the biggest question companies approach FDA with on this topic these days?

BP: With thousands of health-related apps available on the market, the primary challenge for companies is understanding whether their app is subject to regulation and if so, which ones and by which agenc(ies).

One recent example that reflects common questions we receive is the launch in April of an online tool to help mobile app developers navigate the federal regulatory landscape and find out which laws apply to them. We partnered with the Federal Trade Commission (FTC), OCR and ONC--all of which have laws that could potentially apply to apps developers (e.g. HHS's HIPPA, FDA's Food, Drug and Cosmetic Act and FTC's Health Breach Notification Rule).  For the FDA, the point here is to provide assistance to these developers so we can encourage the development of innovative products while also balancing patient safety.

MD+DI: What are some simple guidelines these companies can keep in mind when trying to make the determination of whether their app falls under FDA purview or not?

BP: The simplest guideline to follow is to think about patient safety. This means companies should think about  the impact on patients and the level of risk posed to patients if the app does not work as intended.

In addition to the online tool on the FTC's website noted above, we have a public facing webpage that includes the final guidance on mobile medical apps to help companies determine when they might need to come to the FDA. We also have dedicated email addresses ([email protected]  or [email protected]) that we encourage developers to use to get in touch with us so we can help.  In short--come to us early in the development process and we're happy to help figure out what may or may not apply.

MD+DI: As medical device companies contemplate incorporating mobile health components into clinical trials, can you offer any insight into how FDA considers such trial data? 

BP: Mobile apps used for data collection in clinical studies are not considered, on their own, to be mobile medical apps.  

The FDA supports using innovative tools during clinical studies that may make data collection easier and more efficient, which could mean getting medical products to patients faster. These types of tools are essentially another electronic method of collecting clinical data. 

We've issued a few guidances to help sponsors who are incorporating mobile apps into their studies:

[Images courtesy of FDA and STUART MILES/FREEDIGITALPHOTOS.NET.]