Devices once used only by medical professionals in institutions are getting smaller and cheaper and finding their way into mobile devices. Some are also going into consumer households, so the U.S. Food & Drug Administration wants to regulate them to ensure the health, safety and welfare of citizens.
On July 19, 2011 the FDA announced it is seeking input on its oversight approach for “mobile medical applications” (apps) that are designed for use on smartphones, tablets and other mobile computing devices. On September 12-13 the Agency held a workshop to clarify its intent and approach and to provide a forum for discussion. Visit this site for workshop details and how to submit comments by October 19.
Four of the workshop presentations are included below. (I found the first and last most helpful.)
- Mobile Medical Apps Workshop Presentation- FDA Draft Guidance- Patel (PDF – 433KB)
- Mobile Medical Apps Workshop Presentation- FDA CDS Systems- Meier (PDF – 116KB)
- Mobile Medical Apps Workshop Presentation- CDS Vendor Perspective- Spestotnik (PDF – 588KB)
- Mobile Medical Apps Workshop Presentation- Defining CDS- Dierks (PDF – 57KB)
With a strong interest in telehealth, I’ve been following news about FDA’s guidance, and several questions remain unanswered. I’m especially concerned with the FDA’s scope, which includes “Mobile medical apps that are (1) a traditional medical device or (2) a part of or extension of a traditional medical device and language such as:
(h) The term “device” … means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
Because I did not attend the FDA workshop to hear the discussion of the presentation slides, and none of the presentations answered my questions, I asked some colleagues in Linkedin discussion groups.
Did you attend? I didn’t get answers to my questions from the presentation material and feel that confusion, uncertainty, and bureaucratic red tape could delay product development in America, putting us behind innovation in other nations. I’m specifically concerned about devices that are viewed as “a part of or extension of a traditional medical device.” The way I read the FDA guidance, regulators could use that language to classify any smartphone or tablet or PC or Wi-Fi router or cellular network used to store or transmit data collected from a medical device as a regulated device itself.
Might the government than use its regulatory powers to determine winners in the market and grant favors to powerful companies with lobbying influence? Might they conclude that Apple’s iOS5 provides better HIPAA security than Android and disallow Android? Might they disallow a smaller cellular carrier because it has less coverage area than AT&T?
I’ll amend this article with any additional information I find.
Video demos of mobile medical apps
Agamatrix WaveSense Diabetes Management App (YouTube 4:29)
The Withings WiFi body scale (YouTube 1:42)
Instant Heart Rate – A heart rate monitor for iPhone (YouTube 1:07)
The iPhone, iPad, iPod Touch blood pressure monitor by Withings (YouTube 1:29)
An ECG for the iPhone (YouTube 3:02, review)
The iPad and the Doctor (YouTube 3:13)