Good news! Eight software functions no longer classified as medical devices under FDA.

Good news for medical device designers. FDA is amending classification regulations as a result of changes made by the 21st Century Cures Act to the Federal Food, Drug, and Cosmetic Act (FD&C Act). These remove certain software functions from the definition of a device  “including software functions that are solely intended to transfer, store, convert formats, or display medical device data and results, including medical images or other clinical information.” The changes apply to software in the following devices and systems:

Calculator/Data Processing Module for Clinical Use
Continuous Glucose Monitor Secondary Display
Automated Indirect Immunofluorescence Microscope and Software-Assisted System
Medical Device Data Systems
Home Uterine Activity Monitor
Medical Image Storage Device
Medical Image Communications Device
Picture Archiving and Communications System (PACS)

Read more in the Federal Register. Hat tip to HISTalk Monday Morning Update

21st Century Cures and Telehealth (US)

Just before the signing ceremony of the 21st Century Cures Act in [grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/12/Barack_Obama_signs_2013_inauguration_proclamation-cropped.jpg” thumb_width=”150″ /]the South Court Auditorium of the Eisenhower Executive Office Building President Obama made special mention of his Vice President Joe Biden and his wife Jill who had spoken of the death of their son due to cancer. Obama also mentioned his own mother who had also died of cancer when she was two and a half years younger than he was himself now. The Act provides $1.8 billion for cancer research according to the Washington Post although the allocation is for biomedical research and is not specifically for cancer research.

What was unsaid at the ceremony was that the Act also has a section on telehealth. The telehealth section of the act requires the Centers for Medicare and Medicaid Services (CMS) to report within one year to Congress on populations of Medicare beneficiaries whose care may be improved by expansion of telehealth services. CMS is also asked to report on the telehealth related work already funded by CMS Innovation, make suggestions on the type of services which might be suitable for telehealth and indicate barriers to expansion. The Medicare Payment Advisory Commission (MedPAC) is asked to identify, by March next year, services for which payment is available through private health insurance plans but not under Medicare. MedPAC is then asked to recommend how to incorporate these into Medicare.

These measures look to expanding the role of and accessibility to telehealth for Medicare beneficiaries. Further, a note entitled “Sense of Congress” states that “It is the sense of Congress that eligible originating sites should be expanded …”. However, unlike the key elements of the 21st Century Cures Act, such as biomedical research, no specific funding has been allocated for the implementation of any telehealth related recommendations. Although some optimism has been expressed about the expansion of telehealth as a result of this Act (see, for example, comments from URAC in HIT Consultant and Healthcare IT News.), with the lower priority on health that is possible from the incoming Trump administration, only time will tell if such optimism is justified.