On July 11, mobile health application store Happtique released a draft of standards for a health and medical app certification program. I served as chairman of the panel that drafted the standards, which are open to public comment until Aug. 17.
While some might say that these standards add barriers to the commercial adoption of these technologies, there are substantial reasons for the need of such certification, as outlined below.
1. Consumers, patients and healthcare providers want reliable, safe apps. Right now health and medical apps are largely unregulated. People want to know if the apps they download meet standards that protect them and their devices. For the critical areas of privacy, security and usability, the Happtique standards draw heavily on work done by the MMA, GSMA, mHIMSS and ACT. In addition, the standards are designed to be consistent with any guidance or rules promulgated by U.S. regulatory agencies such as the FDA, FCC, FTC and ONC. These standards give significant comfort to app users looking for quality products when it comes to their wellness or healthcare. While there will be changes made to these standards over time -- dictated by changes in technology, regulatory requirements or user expectations -- certification will always represent a mark of excellence.
2. App stores will request or showcase certified apps. Commercial enterprises, hospitals and others are developing custom app stores for healthcare. They may represent app distributors, users or both. In either case, they will desire the apps to meet standards expected of CIOs, clinical administrators, risk management group and institutional regulators. The owners of these stores might look to purchase only certified apps as a sign of their quality to users. The safety and privacy standards will be especially important in these environments.
3. Certification standards will serve as a guide for app developers. If app developers have access to a comprehensive set of standards (as is furnished in the certification submission form), the development process can be focused, streamlined and economized. This certification process represents, aside from any necessary FDA approval process, one-stop shopping for questions about best practice for app developers.
4. Certification will become a competitive advantage in the marketplace. Having an app certified as meeting all the required standards may certainly be used when advertising the app to a consumer, payer, patient or provider. It immediately makes a statement about the quality of the product. Though it doesn't differentiate it from another certified app in the same area (the certification is an all-or-nothing designation), it jumps it to the front of the quality line.
5. Certification might become a standard for reimbursement and formulary placement by payers. The prescribing of medical apps will be a game-changer for the pharmaceutical industry. It will also change healthcare in general. It is possible that payers will position apps on formularies as they do pharmaceuticals. A certification designation might trigger a higher formulary position.
While none of these justifications for app certification are definitive, common wisdom and historical perspective dictate that some or most are accurate or plausible. Medical apps present a new paradigm in healthcare, and new ways of evaluating them are necessary. Today a large part of the healthcare system fabric consists of certifications. Certification implies meeting defined and accepted standards easily transmitted to a user of a product or service.David Lee Scher is a former cardiac electrophysiologist and is an independent consultant and owner/director at DLS Healthcare Consulting, LLC, concentrating in advising digital health companies and their partnering institutions, providers and businesses. A pioneer adopter of remote cardiac monitoring, he lectures worldwide promoting the benefits of digital health technologies. Follow him on Twitter: @dlschermd. He was cited as one of the 10 cardiologists to follow on Twitter and one of the top ten blogs on healthcare technology.