The FDA's role in telemedicine is still a moving target

Until the Food and Drug Administration (FDA) releases its final guidance for mobile medical applications and clinical decision support (CDS) software, the telemedicine industry is left with trying to figure out what role the agency will play.

Figuring out whether an application will be regulated is a guessing game at best – a point that was well illustrated in a Monday afternoon public policy session.

Bradley M. Thompson, MBA, JD, a partner at Epstein Becker Green, served up two use cases and sought advice from a panel of “expert advisors” to guide him on whether his imaginary applications would be under FDA scrutiny.

After listening to Thompson’s presentations of his “company’s” applications, Robert Harasy, project specialist-customer operations manager for Partners Healthcare’s Center for Connected Health; Yishai Knobel, an mHealth entrepreneur; Stuart Blitz, director of worldwide commercial development for AgaMatrix; Andrew J. Rosenthal, chief strategy officer of Massive Health; and Chuck Parker, executive director of Continua Health Alliance, quizzed Thompson and laid down their judgments.

The first use case involved mobile applications. The proposed July 2011 guidance document breaks down mobile applications that it regulates into three buckets: Applications that act as an accessory to medical devices, applications that transform the mobile platform into a medical device and algorithms that output a patient-specific result, diagnosis or treatment recommendation to be used in a clinical practice.

It does not regulate e-copies of medical textbooks loaded on smartphones, applications solely used to provide clinicians with training or apps solely used for general health and wellness. However, there is a gray area – Footnote 13 – which Thompson pointed out is the “stuff in the middle that the FDA is not sure about.”

That gray area, which includes applications that only automate common medical knowledge, allow individuals to self-manage their disease and automate the common clinician’s diagnostic and treatment tasks using simple general purpose tools, can be confusing.

The first case study involved the development of an application that manages data on a consumer’s weight, calorie and nutrition intake, exercise, sleep and stress. The fictitious company is working with a national diabetes group to create a big marketing campaign aimed at people with diabetes and is anticipating allowing physicians access to the data.

The answers to the question of whether the application should be regulated by the FDA ranged from yes (the application is dealing with a disease state) to no (the application is just automating a manual process) to recommendations of tweaking the product to avoid regulation (step back from some cause-and-effect and correlation claims made by the company). The variety of takes illustrates how confusing the issues are, Thompson said.

Thompson pointed out that while the CDS software guidance document has yet to be written, it has developed categories (preliminary definition, conversion of data and clinical decision that results in patient-specific and actionable result), as well as the degree of regulation associated by high and low risks. High-risk software includes radiation dose calculators, while low-risk includes medication reminders. The FDA has indicated that clinical workflow analytics and financial analysis software and software used for general medical reference or education are not considered CDS software.

The second use case involved the freedom of users to develop their own tools or modify another tool, and the question centered on how much latitude developers have before the FDA regulates their application. The developer in the example was a healthcare system that took another application and changed the user interface for its physicians’ use.

Expert responses to the question ranged from no (if the application was internally developed and used to guide physicians in the practice of medicine) to yes (if the original application was substantially changed and it is given to other physicians outside the healthcare provider). Others were on the fence, but noted that changing the product changed the risk profile, which would keep some up at night and in conversation with attorneys.

The use cases illustrated that there is still “a lot of groping to figure out what to do as we wait for FDA to release final rules,” Thompson said.