FDA – mHealth’s Angel or Demon?

In the rush to get a chunk of Obama’s healthcare billions, any industry with the slightest idea about remote healthcare is doing their best to claim that they are the rightful recipient of the cash.  The latest of these is the CTIA, who recently held a policy forum featuring medical experts and government officials.  In it they touted the promise of mobile health applications that would drive down costs and improve the quality of care.  They admitted that they didn’t have a policy yet, but they certainly want a chunk of the action for their members when the $19 billion dollar treasure chest is opened.  They’re not alone, but amongst all of the feverish lobbying going on in Washington there seems to be a total neglect of the role of the FDA.  Instead there’s a general opinion that a good PowerPoint and drinks for enough politicians will overrule any regulatory requirements.

mHealth has been (and still is) a long time in coming.  There’s a whole host of reasons for that.  It’s trying to grow up in a room full of 800 pound gorillas, amongst them technology, resistance from the medical profession and a lack of standards.  But hiding behind the visible 800 pounders is the big brother of invisible gorillas – the Food and Drugs Administration, fondly know as the FDA.

The FDA is responsible for regulating medical devices and services in the U.S.  If they say a product or service can’t be offered, then it’s effectively dead.  It provides a barrier to entry for manufacturers and services in the medical and health arena.  So far, it’s had little to say about many of the visions of the mHealth industry, but there is no doubt that it will.  I recently saw a presentation that outlines just how wide its powers and scope are.  And they are wide.  If the FDA enforced the most aggressive interpretation of its rules it could probably stop sales of the iPhone today.

I’m sure it won’t.  This isn’t a rant against the FDA, but about the relative naivety of many of the organisations claiming to offer solutions in their quest for a part of the new healthcare pot.  The future of mHealth would be far better served if organisations like the CTIA concentrated less on the high level fanfares and started engaging in informed debate about how the regulatory regime needs to change.

 The FDA was set up to protect patients from unsafe or fraudulent medicine.  Most countries around the world have a similar regulatory organisation, but the size of the US and the scale of its medical industry mean that it’s by the far the most significant of these bodies.  It sets down the regulatory barriers that manufacturers and service providers need to be met before a product can be shipped in the U.S.  And its work is sufficiently well respected, that most other countries place similar requirements on medical products.

Few people are aware of the potential breadth of its powers.  As well as setting down strict guidelines for the performance and accuracy of medical monitors, its remit extends to medical systems.  It has the power to regulate an overall system that affects the treatment of patients, including medication regimes.  In terms of what it can control, or prohibit the sale of, it has the final say over any product that is advertised as enabling either of these situations.

Let’s look at what this means.  The simplest type of mHealth is notifying patients of their next appointment.  That doesn’t directly influence something we take, so it’s not covered by FDA requirements.  A number of phone companies already offer systems like this, including Vodafone.  But if the doctor were to call to remind the patient to take their medication each day, that could be considered as slipping inside the FDA’s remit. 

The FDA’s power to stop the shipment of products technically covers any product that is advertised as a part of a health service.  Hence the comment above that they could stop Apple shipping iPhones.  The Apple Apps Store currently list around 1,500 health applications, which include medical reminders.  If Apple were to mention any of these in its advertising or publicity, the FDA would probably be within its rights to ban the sale of the iPhone.

That’s an awesome level of power.  I don’t for one moment expect FDA inspectors to turn up at Apple Headquarters to serve an injunction, but it indicates how far the market has moved ahead of where anyone originally expected healthcare to go.  The Apps store is a clear indication of where mHealth is heading.  I believe that the introduction of Android, which can connect directly to consumer health devices, such as Bluetooth enabled medical products, will provide a platform that accelerates this kind of innovation.

It’s vitally important that the groups that are going to be involved in these innovations start to engage with the FDA and other regulatory bodies now.  When mHealth starts to happen, it will result in major changes in the balance of power within the medical profession.  By bringing power to the patient, its effect is likely to be as great as the introduction of the printing press was to society in the fifteenth century.  Elements within the existing medical ecosystem are going to lobby furiously to maintain the status quo.  That’s why it’s important to have the debate now, before vested interests come into play to inflame it.  If we don’t engage with the regulators now, mHealth is likely to become mired in legal challenges, particularly in the U.S., which would be tragic, as the U.S. economy and healthcare system needs mHealth more than any other country in the world.

Fortunately, there is a strong ray of sanity shining from the Continua Health Alliance.  Continua has brought together a wide range of players to produce interoperable standards for medical and health devices.  That’s been a major achievement in itself.  However, I think history will look back and see Continua’s greater achievement as galvanising a diverse range of industry partners to come together to talk about a common cause.  Continua includes experts from health providers, insurers, medical device manufacturers, technical standards groups and even a few far-sighted mobile operators, such as AT&T and O2/Telefonica.  They’ve formed a regulatory group, which is discussing these issues with the FDA and regulators around the world.

This is the approach that needs to happen if we’re going to see a smooth evolution and deployment of mHealth.  Putting out press releases and lobbying may win a short term chunk of Obama’s cash, but it ignores the important work that needs to take place on the foundations of mHealth.   We need regulation.  mHealth is the new wild West of personal medicine, which will inevitably attract its share of quacks and charlatans, and it is right that vulnerable patients are protected from these.  I’d urge any other organisation, like the CTIA to join the Continua alliance and enter a co-ordinated discussion with the FDA.  If they don’t we run a real risk of cavalier deployments that end up in legal test cases, which will end up slowing innovation and deployment.  That is not the best way to reform healthcare and empower patients.

The desire of the U.S. administration is a great opportunity to reform healthcare and empower patients.  It is vitally important that it is tackled responsibly and not just seen as a short term grab for government funds.