US legislators have proposed establishing a federal policy for reimbursement of telemedicine and mobile medical devices in order to increase public access to such technologies within health programs including Medicare, Medicaid and the Children’s Health Insurance Program. Introduced recently in the US House of Representatives, the Telehealth Promotion act of 2012 (H.R. 6719) would remove all arbitrary coverage restrictions for medical devices and services provided via telecommunication platforms under federal health insurance systems, and would also create financial incentives for hospitals utilizing telemedicine to reduce rates of readmissions.

It’s not just the US Food and Drug Administration mulling over how to regulate mobile medical applications these days. The US Federal Trade Commission (FTC) has also recently come out with guidelines for medical app developers targeting advertising and privacy issues. The FTC recommendations cover basic legal requirements that medical app manufacturers must meet in order to market their products, introducing obligations for these companies to be met along with FDA medical device registration requirements.

Can minimally-staffed software application developers getting into the medical device sector reasonably be expected to comply with the same FDA requirements as medical device manufacturers?

In einer vor kurzem veröffentlichten Publikation über Sicherheitsmaßnahmen empfiehlt die US Food and Drug Administration aufgrund des zunehmenden Einsatzes von Computersystemen, mobilen Technologien und Netzwerken die Umsetzung von angemessenen Sicherheitsvorkehrungen durch Medizinprodukte-Hersteller und Gesundheitseinrichtungen. Die FDA empfiehlt insbesondere Medizinprodukte-Herstellern einige Sicherheitsmaßnahmen, die der gängigen Norm entsprechen:

Highly anticipated final guidance issued by the US Food and Drug Administration indicates a limited approach to regulating mobile medical apps, with no plans by the agency to enforce Federal Drug & Cosmetic Act requirements for most of these products.

Medizinprodukte-Datensysteme, die zusammen mit digitalen Gesundheitstechnologien verwendet werden, müssen nach einer neuen Richtlinie nun die Vorschriften der US Food and Drug Administration nicht mehr erfüllen.

Medical device data systems (MDDS) used to support digital health technologies will no longer be required to comply with the US Food and Drug Administration’s regulatory controls, according to new guidance from the agency.

Das südkoreanische Ministerium für Lebensmittel- und Arzneimittelsicherheit (Ministry of Food and Drug Safety, MFDS) hat bekannt gegeben, bestimmte mobile Fitness-Medizinprodukte von den Registrierungsvorschriften auszunehmen — einschließlich der mobilen und tragbaren Galaxy-Fitnessprodukte von Samsung.

The South Korean Ministry of Food and Drug Safety (MFDS) has announced steps to loosen medical device registration requirements (link in Korean) for some fitness-related mobile medical products—including Samsung’s line of Galaxy mobile and wearable products for leisure and fitness use.

Das US-Repräsentantenhaus und der Senat erwägen, bestimmte Typen von Software, mobilen Medizinprodukten und Apps von der Aufsicht durch die Food and Drug Administration auszunehmen.