Is Apple's FDA policy reasonable? Point, counter-point

By Brian Dolan

Medical device connectivity and workflow automation consultant, Tim Gee, also known as the Connectologist, started a helpful discussion on LinkedIn about Apple's recently disclosed developer agreement and its moves to avoid FDA regulation. As we reported recently, the agreement puts the onus on medical app developers to clear their app with the FDA if necessary and to not involve Apple in any way. Gee's initial thoughts served as a jumping off point for Audi Lucas, a networked systems manager at Draeger Medical who made clear his opinions were his own and not necessarily shared by Draeger. Here's the discussion:

FDASo, was Apple's FDA policy reasonable?

Tim Gee: I'd say yes, Apple's position is reasonable. No company wants third parties -- especially loosely connected third parties like iPhone developers -- to create regulatory requirements for them. Their license does not preclude them from working more closely with another company to create something that does result in some sort of regulatory burden for Apple. They just don't want third parties making those decisions for them, and telling them in the middle or at the end of the development cycle.

Apple's biggest regulatory issues will revolve around what the FDA calls labeling. Should Apple market an iPhone app that meets the definition of a regulated medical device as a vehicle for marketing the iPhone, they would likely be exposed to some degree of regulatory liability.

Further, the listing of a medical device in the app store is also labeling, and will have to be handled carefully. And finally, simply selling an app that meets the definition of a medical device places Apple in the role of a sales channel for the app -- this too incurs regulatory exposure.

I'm sure Apple has hired some regulatory consulting firm to dot all these i's and cross all the t's. And if not, they may someday meet a guy with a badge at their offices in Cupertino.

Audi Lucas: I think it depends in part on exactly what kind of medical device you are incorporating the iPhone into. As I see it, other than the normal IS/PDMS type of app, most of the "regulated" apps will involve some other pieces. With the opening of the interface port in 3.0 this will probably involve some sort of HW and/or server based SW, i.e. the blood pressure cuff use case mentioned in the keynote. In such a case the company developing and marketing such a system would be responsible for getting 510K and CE approval on the entire system. Apple is then simply a supplier of a component as would any other supplier of chips or PCB's in any other system.

The trick will be for those companies seeking 510K or CE to show they have the necessary quality mechanisms in place to prevent a failure in the case the iPhone SW changes or the user adds other apps to the phone. This may be similar to the situation faced by those companies allowing third party apps to be loaded on medical grade PC's which are part of a regulated system/device such as a patient monitor. Think of all of the Advantek PC's that are used in conjunction with patient monitors today.

I think the iPhone presents a platform that could really shake up parts of the medical device market (if companies can get a 510K/CE). No longer will companies be able to rely on the hurdle of smaller developers being able to develop and produce their own complete HW system, but will only need to be able to supply the sensor components. Think in the direction of the thousands of hand held SpO2, blood pressure, or thermometer boxes in physician offices and ER's. The iPhone may actually become the tri-corder from the original Star Trek.

I do agree though Apple needs to look at this a bit closer and at least figure out what these companies need in the way of controls, paperwork, and possibly special HW releases to support this industry. I remember the issues Cisco faced when they started to try to market solutions directly to hospitals.

Tim Gee: Great point Audi. Managing the risks due to changes in the iPhone (installing new versions of the OS, or possibly even installing other apps) without the medical device manufacturer having ensured that such changes do not impact the safety and efficacy of the overall medical device is a big challenge.

However 3.0 of the iPhone OS facilitates that will be an important issue for regulated manufacturers. A manufacturer's regulatory strategy and design approach may also serve to effectively mitigate this risk.

There are a lot of health care IT vendors writing apps to support EMRs and other things. Any vendors that implement designs that negatively impact the platform for medical device manufacturers will be disadvantaged -- with both their customers and the medical device mfgs.

Device virtualization (what you describe as a sensor integrated with an app on the iPhone) has been gaining steam in the physician office market for some time. The iPhone would make a great platform for this (in more than just the doctor's office), and the Continua test and certification could help ensure cross vendor support. (Apple should seriously consider joining Continua.)

Cisco learned a few years ago about the regulatory issues surrounding marketing horizontal products in health care. A released brochure showing a 7920 wireless VoIP phone with an ECG waveform on the display prompted an unannounced enforcement visit from the FDA. If Apple is not careful, they will find themselves across that line. The presentation during the initial ver 3.0 iPhone OS announcement that included talk about the OneTouch feasibility project may have already crossed the line.