The introduction of thousands of mobile health apps in the past few years has led to consumers having access to unprecedented technologies, many of which claim to help manage medical conditions, promote health and well-being and expand the level of care. Medical web development and healthcare mobile apps are being adopted almost as quickly as they can be developed.
Apps that count calories, monitor your heart rate or even manage insulin doses for diabetics are all available for download in the Apple App or Google Play Store. But can you trust these apps in the same way you can trust other medical devices?
The FDA points out that it encourages the development of mobile medical apps, yet it also has a duty to oversee the safety and effectiveness of these apps. It applies the same risk-based approach for assessment as it does for other medical devices, yet it’s still a fairly unregulated market.
For every FDA approved app, there are a large number that aren’t approved, and while some of these are low risk, other more ambitious apps that claim certain health benefits may not have been tested and evaluated by healthcare professionals. Regulation for these types of apps is necessary to avoid posing risks to patients if they aren’t functioning properly.
And while regulation is necessary, it’s still slightly ambiguous and what constitutes a medical app or a health and fitness app can be a blurry line.
Certainly, legitimate apps that have been developed in conjunction with healthcare professionals can have significant benefits. In February 2011, the FDA gave approval to the first medical app that allows physicians to view X-rays on a mobile device.
Which Mobile Health Apps should you trust?
Healthcare web development continues to build momentum with tech companies like Microsoft, Siemens and Dell lobbying against too much FDA regulation, which they state could stifle innovation. And while there are hundreds of apps that lay claim to unsubstantiated claims and can mislead users, there are some apps that are actually helpful.
Look for mobile apps that meet HIPAA regulations and comply with regulatory guidance and standards found in healthcare. For example, if a diabetic is seeking an app to help manage the condition, choose one that the FDA has cleared in pre-market review. You also want to make sure that the app is reputable, has been updated, and doesn’t have any bugs. The developers should have gone through the process to identify what regulations and standards apply, and ideally received third party testing on their product.
[Tweet “Mobile apps should meet HIPAA regulations and comply with regulatory standards. #mHealth”]
However, keep in mind that medical apps may not have been as rigorously tested as medical devices or new drugs. The best and most effective use of these apps will be a joint decision between patient and doctor.
Medical wearables, such as the FitBit wristband that tracks daily activity, can also be highly beneficial to provide data for physicians, yet it still isn’t 100% reliable.
The market for medical apps has exploded in recent years and even greater advances in medical web development is in store for the future. Along with this, the regulatory landscape is likely to evolve and develop alongside the technology. The real transformative power of medical apps may still be yet to come, when there is greater assurance over a larger number of approved and safe apps for patients and providers.