Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "IMS Health Suggests All Mobile Medical Apps Be Subject to Clinical Trials."
Following is an excerpt:
Mobile medical health application developers may need to generate clinical trial data about their products before payers and physicians will be convinced to broadly embrace the products, according to a recent report from IMS Health. The group said integration with electronic health records and the establishment of privacy guidelines could also expedite wide use of the apps among health care providers. ...
IMS also writes that while there are divergent views within industry on the need to conduct randomized clinical trials, those arguments tend to be based more on logistics than evidence requirements. Those opposing randomized trials have argued that the cost would be a barrier to small app developers and it would take too long to generate results from the trials considering the pace at which technology evolves. Further, IMS points out that it has been argued that FDA has approved multiple medical devices without requiring randomized trials because of the low risk of harm. Some stakeholders have said there is no reason to believe that apps would be treated differently, especially since FDA has said it will likely use enforcement discretion for the majority of apps, according to the report.
Bradley Merrill Thompson, an attorney with Epstein, Becker & Green, agreed that it would be beneficial if companies could differentiate their products through marketing that shows the product works. However, he added that it remains unclear whether the companies that invest in generating clinical trial evidence would have any advantage over competitors.
"With an app, you're not talking about something as unique as a drug," Thompson said. "A lot of apps do the same thing. If you do research, it really means everyone in your category can lay claims to the same benefits." ...
Thompson said the mobile health industry will either need to develop a model that privatizes clinical trial benefits or that "passes the hat." As mobile medical apps begin to yield more significant benefits and risks, developers will need to provide more evidence to convince people to use them, he said.
