It's a Tough Job but Someone Has to Do It
By Paul Nerger, Senior Advisor
January 23, 2012
I'm proud to be associated with a company like Happtique, which has the courage to stand up and take on what will be one of the toughest jobs in the mHealth industry. What am I talking about? The recent announcement by Happtique to tackle the issue of app certification. It is estimated that 12% of medical apps in the marketplace could be classified as medical devices and thus be subject to FDA approval. But what about the other 88%? A few of these apps will be shut down by the Federal Trade Commission, which recently forced Apple to remove 2 apps that claimed to cure acne through the use of the iPhone’s built-in flash, but these will be the exception rather than the rule. The vast majority of apps simply would not have enough independent information about them to allow consumers or clinicians to make an informed decision as to whether the app is worthwhile.
So, how does Happtique propose to do this? First, we have formed a blue-ribbon panel of experts. The panel will have representatives from the physician, nursing, technology, and patient communities. Their goal is to develop open standards for evaluating mHealth apps, which means open feedback and open for improvement. Standards in healthcare accreditation and certification programs have always been open and it’s important for the technology community to embrace a similar criteria. Most app markets have an approval process, but the process is not transparent. Developers might be told why their app was approved, but they are often held to a non-disclosure agreement as to why their app was denied. An open standard allows everyone to improve.
As I mentioned previously, the panel will be multi-disciplinary. The members include:
• Howard J. Luks, MD, a surgeon who has made a reputation for using social media to improve the quality of healthcare
• Franklin A. Shaffer, EdD, RN, a professor of nursing who plays a vital role in certifying global nursing programs
• Shuvo Roy, PhD, a professor who is part of an MD and Engineering PhD program that is laying the groundwork for using technology to solve real-world medical problems
• Dave deBronkart, widely known as e-Patient Dave, who—as a cancer patient and blogger—became a key activist in the field of participatory medicine and personal health-data rights
This panel is uniquely equipped with both expertise and diverse perspectives, which combined with the familiar principles for accreditation and certification, can professionally address our industry’s need for self-regulation. If we get this right, not only will the entire mHealth industry benefit, but the ultimate goal of mHealth—to reduce costs while improving the quality of care—will move closer to realization. They certainly have my support. I hope that they have yours.