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10/25/2011
05:02 AM
Paul Cerrato
Paul Cerrato
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Should Mobile Medical Apps Require FDA Approval?

The new FDA guidelines may create headaches for developers, but there is an upside for doctors and patients.

No matter how hard the Food and Drug Administration tries to find a middle ground between too much and too little regulation, it's usually seen as the villain. When it implements strict rules on drug approval, for example, it's condemned for slowing down the pipeline of lifesaving remedies. And when the agency loosens its grip, it's blamed for deaths from unsafe drugs.

The FDA's new guidelines on mobile medical apps are likely to put it into a similar position. Some software developers will complain that the regs, which are still in the draft stage, will make it impossible for them to bring valuable products to market. But had the FDA done nothing, other critics would question whether the agency is protecting the public from unsafe or ineffective software.

Before jumping to either conclusion, it's important to take a closer look at exactly what the FDA is proposing.

One of the most important distinctions the agency makes is between apps that promote wellness and good health versus those that are involved in the diagnosis, treatment, cure, or mitigation of a disease. The former group of apps doesn't need FDA approval.

[ Today's mobile devices have transformed medical care in unprecedented ways. For an in-depth look at exactly how clinicians are using these tools, tune into the InformationWeek Healthcare Webcast The Mobile Point of Care: Making the Right Choices. ]

Among the wellness-related mobile health applications that are off the hook are those that log, record, or track eating habits or exercise. Similarly, a medical reference app such as the Physicians' Desk Reference doesn't require approval. Other safe bets are mobile apps that perform the function of an electronic health record or personal health record. Apps to determine medical billing codes and perform other medical business functions are also exempt.

On the other hand, Mobile MIM, which lets clinicians view full-resolution medical images, does require FDA approval--which the vendor has already secured. As the FDA draft guidelines explain, "a mobile medical app that displays radiological images for diagnosis transforms the mobile platform into a class II PACS [picture archiving and communication system]," and such systems require clearance.

Similarly, an app like AirStrip OB, which displays real-time fetal heart rate monitor data, requires FDA approval.

The FDA guidelines also suggest that certain clinical decision-support tools may come under scrutiny. Among the apps considered medical devices and thus subject to FDA clearance are "mobile medical apps that allow the user to input patient-specific information and--using formulae or a processing algorithm--output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions."

That sounds an awful lot like IBM's Watson supercomputer. So while Watson itself isn't a mobile app, what happens when someone builds an app to tap into Watson's diagnostic engine? It's clear many mobile app developers are in for a bumpy ride. But in the end, it's worth it.

The FDA's blessing will mean credibility, proven effectiveness, reimbursement from insurers, and safer patients.

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BBINDER000
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BBINDER000,
User Rank: Apprentice
10/26/2011 | 7:43:21 PM
re: Should Mobile Medical Apps Require FDA Approval?
I've worked extensively in both development of FDA regulated devices and mobile app testing. I've recently blogged about both questions:

D+j+ vu All Over Again G The Mobile Testing Nightmare
http://www.robertvbinder.com/b...

Competent, Mediocre, or Dangerous?
http://www.robertvbinder.com/b...

The short version: I think the FDA has gotten the general requirements for developing high reliability software-intensive products about right, but the onus for achieving this high quality is on the development organizations. There is wide variation in interpretation, which can lead to inadequate development practices.

I don't see any essential difference in the general requirements for developing high quality systems with mobile endpoints. However, verification and validation of a system with mobile endpoints is *more* difficult than a wired client/server system, other things being equal. Owing to lack of experience, many assume that mobile endpoints are easier to develop/test.

The new FDA Guidance delimits when mobile platforms are considered as part of regulated system or not. I don't see anything in the guidance that calls for a different approach to developing, verifying, or validating included systems. The criteria for inclusion of a mobile endpoint seems to be that if it supports a feature which is regulated, then the mobile endpoint is also regulated.

I hope that developers using mobile end-points for regulated systems will take the unique challenges of mobile in to account in planning their V&V.

Bob Binder

Lisa Henderson
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Lisa Henderson,
User Rank: Apprentice
10/27/2011 | 1:29:11 AM
re: Should Mobile Medical Apps Require FDA Approval?
I agree with you Paul .... I think the FDA does get a bad rap and when it tries to overcorrect, as may have happened with some of the drug regulations you mention, it can cause a lot of time, money and resources for the pharmaceutical companies. But truly, in the end, with drugs and with applications, those that will help with proven effectiveness and safer patients.

Lisa Henderson, InformationWeek Healthcare, contributing editor
MedicalQuack
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MedicalQuack,
User Rank: Moderator
10/31/2011 | 6:47:55 PM
re: Should Mobile Medical Apps Require FDA Approval?
Certainly there's a bit of caution when technologies with Big Data capabilities are fed information to query from...approach with caution...

http://ducknetweb.blogspot.com...

There's a lot of flawed data out there right now and if this is all sent to data bases for search, it somewhat defeats the purpose...Numbers don't lie but people do...

http://ducknetweb.blogspot.com...

The FDA needs more engineers just all business does to accomplish this project too, I don't know who doesn't get this part of the equation, other than our Congress who has a proven record of digital illiteracy. They too need Big Data tech to make better laws.

http://ducknetweb.blogspot.com...
RCORPUS000
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RCORPUS000,
User Rank: Apprentice
10/31/2011 | 8:07:39 PM
re: Should Mobile Medical Apps Require FDA Approval?
"The new FDA guidelines may create headaches for developers, but there is an upside for doctors and patients. "
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