Recent word has been that the FDA is really going to listen to the industry, and be kinder and gentler on smartphone medical apps [TA 25 Aug 11]/ Not according to Joel White, executive director of the Health IT Now Coalition, writing in the Washington Times. FDA continues to ‘explore options to regulate mobile medical applications as medical devices under the Food, Drug and Cosmetic Act, particularly around adverse-event and patient-safety reporting.’ With approvals taking up to three years and millions to file (and prove), plus a 2.3% medical device tax to fund, free and low-cost apps might be a lot more expensive. Plus it throws a ton of sand into efforts by other parts of the government to encourage outcomes-based care to lower costs, which use telehealth for consumer engagement. FDA’s assault on mobile technologies; New regulations could be death blow to smartphone medical apps.
Updated 12 Feb, related ‘monkey wrench’: Jon Linkous on the cost of cross-state licensure for physicians, which is both a tax in and impediment to implementing telehealth-based care management and telemedicine. 22% of US physicians already are licensed in more than one state–here in the NYC metro it’s quite common for both New York and New Jersey physicians (and the same in the Philadelphia metro Pennsylvania and New Jersey).