[Ed. This is the third of a three part series examining the past & present of FDA regulation of mHealth]
The debate over the adoption of electronic health records and health IT systems by physicians has largely focused on the concept of “Meaningful Use”. It was this term chosen by the Dept of Health and Human Services Office of the National Coordinator (ONC), the sub-agency charged with distributing subsidies awarded in the Obama stimulus to physicians who adopt electronic medical records, as its baseline measure when providing guidance to physicians on how they would ultimately determine eligibility for federal aid.
The FDA released new guidelines for comment this week on how they will regulate mobile applications, or more specifically, how they will determine when a mobile application is actually a mobile medical device. Taking a cue from the ONC, the agency wrote a document that could be summarized in two simple words, “Intended Use”
“When the intended use of a mobile app is the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device”.
As in all matters bureaucratic, the subtleties of language, even one or two words among tens of thousands, can have significant ramifications for many stakeholders.
The FDA did a great job of providing a clear taxonomy of the mobile health ecosystem. They offer significant clarity for the different elements and obligations of various stakeholders involved in the design, development and distribution of “mobile medical apps”.
The document makes very clear where, or rather with whom, ultimate responsibility lies for a particular application and its compliance with regulatory oversight. The “author”, or the individual/entity that conceived of AND designed the specifications of the app, bears the final responsibility of applying for and receiving regulatory approval. The “developer”.
“Intended Use refers to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such person’s expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives”.
One very important distinction made by the FDA was on the matter of how to determine the “manufacturer” of a mobile medical app. This is important because it is the manufacturer who is solely accountable to the regulatory group, though the actual “developer” of the device may be a contracted third-party. A manufacturer is the person or group that conceives of and designs the core requirements and functionality of the device, or the “author”.
“…manufacturers of a mobile medical app would include persons or entities who are the creators of the original idea (initial specifications) for a mobile medical app, unless another entity assumes all responsibility for manufacturing and distributing the mobile medical app, in which case that other entity would be the manufacturer. Software “developers” of a mobile medical app that are only responsible for performing design and development activities to transform the author’s specifications into a mobile medical app would not constitute manufacturers, and instead the author would be considered the manufacturer”.
The report allows handset developers, “If it is possible to run mobile medical apps on BrandNamePhone but BrandNamePhone is not marketed by BrandNameCompany with a medical device intended use, the BrandNameCompany would not be a medical device manufacturer.”
App Stores are also given a pass for now, “É-mobile platforms” are defined as commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature, include mobile computers such as the iPhone¨, BlackBerry¨ phones, Android¨ phones, tablet computers, or other computers that are typically used as smart phones or personal digital assistants (PDAs)”.
A “mobile medical app” is distinguished as a mobile app that meets the definition of “device” in section 201(h) of the FD&C Act and either: (1) Is used as an accessory to a regulated medical device; (2) transforms a mobile platform into a regulated medical device.
There is a clear distinction made that might (but probably won’t) have implications for developers of “closed systems”, such as Apple’s iOS or HP’s WebOS platforms. It would seem under these guidelines Apple and HP could never market their consumer electronics products, such as the iPad or new HP TouchPad directly to providers or health systems without evoking uncertainty as to the “intended use” of the device. Its doubtful the FDA would prevent the iPad 3 from being marketed in the US until it was approved, but a closed system raises more questions than the open system business model of Google and Android.
Apple’s quarterly earnings show the iPad and iPhone have grown to 68% of the company’s revenues. Mobile devices are the future of Apple, and as a closed system the company will need to carefully market its products, or simply welcome FDA approval and aggressively sell their iPads to health systems with iCloud for the enterprise supporting every bed and every health professional on premises.