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:

A recent safety communication from the US Food and Drug Administration recommends appropriate and well-maintained security controls by medical device manufacturers and healthcare facilities as the use of computer systems, mobile technologies and networks becomes more widespread.

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?

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.

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.

US-Behörden haben eine bundesstaatliche Richtlinie zur Erstattung von telemedizinischen und mobilen Medizinprodukten vorgeschlagen, um den öffentlichen Zugang zu diesen Technologien im Rahmen von G

The US House of Representatives ‘ Energy and Commerce committee will hold hearings over three days in mid March regarding the Food and Drug Administration’s approach to regulating mobile medical applications and telehealth products.

Das Committee on Energy and Commerce des US Repräsentantenhauses wird Mitte März eine dreitätige Anhörung zu den Vorschriften der Food and Drug Administration in Bezug auf mobile Medizin-Apps und Telegesundheitsprodukte durchführen.

Testifying before a US House of Representative hearing on mobile medical technology on March 21 st , FDA official Christy Foreman indicated that the agency’s approach to mobile medical app oversight will not include smartphones or tablets used to access such devices.

Die leitende FDA-Beamtin Christy Foreman deutete in einer Anhörungvor dem US-Repräsentantenhaus am 21. März zum Thema mobile Medizintechnik an, dass die Richtlinien der Behörde zur Überwachung von mobilen Medizin-Apps nicht auf Smartphones oder Tablet-PCs gelten, die zum Zugriff auf mobile Medizinprodukte verwendet werden.