Envisioning a day when physicians prescribing health and medical apps is commonplace and, more significantly, in the absence of any formal review process, a private company has published certification standards and announced review boards to help hospitals and consumers cut through the crowded medical, health and fitness app market.
The move is designed to raise the bar in what has been pretty much an anything goes, buyer beware market where there’s a lot of variety, plenty of duplication and some questionable options. With some of the worst ones, the Federal Trade Commission has fined companies.
App developers that want to reach providers that adhere to the certification standards will have to submit to a formal review process. The voluntary program will be open to all app developers and will be funded by developer application fees that will run somewhere between $2,000 to $3,000. Although developers can fill out certification forms now, they won’t actually be able to submit applications until the certification portal opens in late spring. The goal is to evaluate apps on a pass fail basis in 30 days or less.
The development comes one year after Happtique submitted draft guidelines for public comment. The standards evaluate operability, privacy, security and content. There are also performance requirements. Although it received input from regulators like the US Food and Drug Administration and the Federal Trade Commission, and the Office of the National Coordinator for Health Information Technology, they did not formally endorse or approve the certification requirements.
In a phone interview with MedCity News, Ben Chodor Happtique CEO, said as the mobile health industry has evolved it was time that app developers became more accountable for their products to ensure they are safe to use. He said the regulatory nature of the healthcare industry justified the certification fee.
“If you are not going to make the commitment to contribute a few thousand dollars for an app that will be used by patients and clinicians then you’d probably think twice about going into a heavily regulated industry… We want every developer to wear that certification badge proudly on their websites.”
Chodor added that since the development of the certification standards began he has seen a lot more apps for interoperability come into the market, particularly for electronic medical records.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The company has also enlisted the help of the Association of American Medical Colleges, which will conduct the content evaluation for apps related to medical and patient education. It is the largest association representing accredited medical schools in the US, and also represents roughly 400 teaching hospitals as well as medical societies. CGFNS International does credentials evaluation for nurses and other health care professionals. Intertek — a testing and certification group — will evaluate the performance of the apps.
Intertek, AAMC and CGFNS are Health App Certification Partners who will evaluate the health apps against the certification standards. Other partners will be added to evaluate apps specific to specialties like cardiology and endocrinology, Chodor added.
Happtique says its standards will help providers and consumers identify apps that deliver credible content, contain safeguards for user data and function, according to a company statement.
Lee Perlman, president of GNYHA Ventures and managing director of Happtique, said in the statement the certification standards will complement the objectives of federal agencies involved in the regulation of mobile health apps.
Depending on how widely adopted the certification process becomes, it could shape the options of app developers. It will give street cred and access to those apps that pass muster and a two year certification for the app(s) submitted. For those that don’t, they may have to focus on the consumer markets. It may truly raise the bar. Just as important, it may go some way to raise the esteem of apps in the eyes of skeptics.
