These Mobile Apps Are Subject to FDA's "Enforcement Discretion." Whaaa?

When I read Dominic Tyer's blog post ("FDA takes 'tailored' approach to mobile app regulation") about FDA's final guidance for regulation of mobile medical applications, the following segment gave me pause:

"The FDA's guidance gives the following examples of apps that it intends to regulate [my emphasis]:

• Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment
• Mobile apps that provide patients with simple tools to organise and track their health information
• Mobile apps that provide easy access to information related to patients' health conditions or treatments (beyond providing an electronic “copy” of a medical reference)
• Mobile apps that are specifically marketed to help patients document, show, or communicate to providers potential medical conditions
• Mobile apps that perform simple calculations routinely used in clinical practice
• Mobile apps that enable individuals to interact with personal health record or electronic health record systems."

If true*, this would be BIG news and would have justified PhRMA's fear mongering regarding the stifling of innovation by FDA regulation (see "Mobile Regulatory Fears: PhRMA Raises an Alarm").

If you download and  actually read the final guidance (find it here), the FDA says on page 16 of the document:



"FDA intends to exercise enforcement discretion [my emphasis] for mobile apps that:

• Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
• Provide patients with simple tools to organize and track their health information;
• Provide easy access to information related to patients’ health conditions or treatments;
• Help patients document, show, or communicate potential medical conditions to health care providers;
• Automate simple tasks for health care providers; or
• Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems."

By "exercise enforcement discretion" FDA means that it "does not intend to enforce requirements under the FD&C Act."; i.e., requirements that such apps be regulated and approved by FDA.

"To clarify some guidance terminology," writes (here) Bakul Patel, senior policy advisor to the center director, Center for Devices and Radiological Health (CDRH), at the U.S. Food and Drug Administration, "the term 'enforcement discretion' means that even if the medical app may meet the definition of a medical device, the FDA can choose to not enforce our requirements because we have determined that the risk to patients is low.

"In the [draft] guidance, we had a sentence to the effect that we will 'decline to pursue enforcement actions' and only choose to enforce something if it raises public health concerns.

"Some might be concerned that enforcement is open-ended, but this is not true. If we were to blanket change the policy, we would follow an open public-input process."

Basically, I read this to mean that FDA might still enforce regulations for such apps on a case-by-case basis if public safety is an issue.

Of interest to me -- and many clinicians -- are mobile apps that perform simple calculations routinely used in clinical practice. These apps, for which FDA does not intend to enforce requirements under the FD&C Act, "are intended to provide a convenient way for clinicians to perform various simple medical calculations taught in medical schools and are routinely used in clinical practice. These apps are generally tailored for clinical use, but retain functionality that is similar to simple general purpose tools such as paper charts, spread sheets, timers or generic mathematical calculators. Examples of such general purpose tools include medical calculators for:

• Body Mass Index (BMI)
• Total Body Water / Urea Volume of Distribution
• Mean arterial pressure
• Glascow Coma Scale score
• APGAR score
• NIH Stroke Scale
• Delivery date estimator"

BMI is simple to calculate, but consider an app that calculates PASI (Psoriasis Area and Severity Index). That calculation is a bit more complicated. Here's the formula:

Also, there is some debate whether this is the right formula to use or if a different one would be better.

Pfizer recalled an app it distributed to physicians because "the Apple iPhone application gives on average a 15-20% higher score for DAS28-ESR compared to a score calculated using the published DAS28-ESR formula (with higher or lower incorrect scores in certain cases). It gives on average a 10-15% lower score for DAS28-CRP compared to a score calculated using the published DAS28-CRP formula. Incorrect values are also obtained for the ASDAS-CRP score (scores are on average 15-25% lower) and for the PASI score (scores are up to 50% lower). There may also be minor errors in the Framingham scores."

When apps are buggy and provide faulty data to clinicians who may ACT on that data -- i.e., prescribe medication when none is really needed -- then, IMHO, it becomes a public safety issue. If FDA does not regulate these apps, there still is a need for SOME kind of oversight to ensure the apps work as promised.

*NOTE: When I mentioned this to Dominic, he edited his post to reflect more accurately the wording of the FDA guidance.