Just about two years ago, the FDA first announced its intention to begin regulating medical apps and soon thereafter released its draft guidance for how it would do so. A few months later, the FTC jumped into the fray and took action against applications that claimed to treat acne with light therapy from an iPhone.
More recently, the FDA took another step forward and put app developers on notice that it is serious about medical apps following regulations with its letter to the makers of Ucheck Urine Analyzer.
A recent study published in Pediatric Diabetes looked at apps available for diabetes management both for patients and healthcare professionals. Focusing on the App Store, they identified approximately 500 apps related to diabetes. Buried in their results, they highlight a few among them that may soon attract the attention of increasingly proactive regulators.
Back in 2011, we noted that there were several apps on the market that functioned as insulin dosing calculators. These apps asked for information on current regimen, diet, goals, and more; they then claimed to output better regimens of long and short acting insulin. The risks here are obvious. Even a relatively minor calculation error could have fatal consequences. In their study, Eng et al review apps related to diabetes, utilizing a search criteria meant to cast a wide net.
Perhaps the most striking was they identified eight insulin dose calculators which give patient-specific treatment recommendations. In our original article, we took a look at InsulinSmart and Insulin Calc. Others available now include Diabetes Carb/Insulin RatioWizard, Insulin Dosing Algorithm, Insulin Calculator, EZ Insulin Calculator, Insulin to Carb (I:C) Ratio Calculator, Diabetic Dosage, BG to Insulin (Correction), Insulin Dose Calculator Pro, and Insulin Dose Advisor. According to the FDA Draft Guidance, these apps would be anticipated to fall under its regulatory purview:
Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.
These apps, we should note, would not necessarily fall under the current draft guidance but rather future anticipated guidance. As noted in the current draft guidance, such regulatory oversight would be weighted to the associated risk of the tool (which I would argue is relatively high for insulin dosing). Currently, software that performs similar functions are classified as Drug Dose Calculators and generally are considered Class II.
These apps fall into a few categories. Some apply vague and undefined algorithms to calculating insulin doses. Others are calculators applying validated tools that output advice ranging for specific doses or correction factors with which to calculate doses. Even among those using reasonable methodology (e.g. those that are effectively transferring a validated paper/pen process to an app), there is really no information on quality control and safety measures employed. Based on these claims, some may be more primed for regulatory intervention in the near term. For example, those that claim to help improve diabetic control by producing more effective dosing regimens may attract FTC interest; otherwise, FDA oversight may be further down the road.
As an aside, there are a number of other findings noted by Eng et al. worth mentioning:
- 33% of apps are for health tracking activities like tracking blood sugar, insulin doses, carbs but none integrated directly into physician workflows or EMRs (aside from WellDoc)
- Only 8% of apps are directed are healthcare professionals
- 5% of apps (around 20-30) were related to social networks
As they noted though, there are many apps in the market that make claims about treatment efficacy and provide very specific medical advice to patients about the dosing of a medication that can be dangerous if not used appropriately. That being said, there is clearly potential value here, enabling more active titration of insulin to achieve better glycemic control faster. For patients on sliding scales and nutritional insulin, we could probably save them a lot of time. Furthermore, we’ve all had patients who incorrectly calculated insulin doses themselves and overdosed.
Whether all of these would garner the scrutiny of regulatory agencies is something only the FDA and FTC can tell us. On first pass, though, they certainly look to be candidates for a closer look. As healthcare professionals, though, the most important takeaway is these apps are out there and our patients may be using them; it is up to us to advise caution and make sure our patients are well informed about the risks.
Reference: Eng DS, Lee JM. The Promise and Peril of Mobile Health Applications for Diabetes and Endocrinology. Pediatric Diabetes 2013: 14: 231–238.
Ed. Note: This article was updated to clarify our view regarding current regulations and timing of potential oversight/intervention.