FDA-FCC meeting: mHealth must consider imaging requirements
Enhanced coordination between the Federal Communications Commission (FCC) and the FDA for future mobile/wireless broadband (mHealth) medical devices and applications--including imaging requirements--were the topic during a roundtable discussion held during a public meeting last week.
The discussions, which featured Michael Tilkin, American College of Radiology (ACR) CIO and staff liaison to the ACR IT and Informatics Committee, also focused on the security, privacy and interoperability considerations, according to the ACR.
“It is important to keep in mind that mobile and wireless broadband considerations specific to medical imaging are constantly changing, and we should keep imaging’s communications requirements in mind when discussing an evolving mHealth infrastructure in the U.S.,” said Tilkin.
Communications devices are regulated by the FCC and medical devices are under the authority of the FDA, which has led to some confusion as communications devices are increasingly used for medical purposes (see CMIO's related story here).
The meeting touched on data integrity and reliability issues arising from the use of allocated spectrum, use of unlicensed devices and the use of commercial networks and applications for medical purposes.
The discussions, which featured Michael Tilkin, American College of Radiology (ACR) CIO and staff liaison to the ACR IT and Informatics Committee, also focused on the security, privacy and interoperability considerations, according to the ACR.
“It is important to keep in mind that mobile and wireless broadband considerations specific to medical imaging are constantly changing, and we should keep imaging’s communications requirements in mind when discussing an evolving mHealth infrastructure in the U.S.,” said Tilkin.
Communications devices are regulated by the FCC and medical devices are under the authority of the FDA, which has led to some confusion as communications devices are increasingly used for medical purposes (see CMIO's related story here).
The meeting touched on data integrity and reliability issues arising from the use of allocated spectrum, use of unlicensed devices and the use of commercial networks and applications for medical purposes.