Saturday, January 11

Tag: 21st Century Cures Act

Nov162024 by adminNo Comments
Legislators ask CDRH to review its CDS assistance

Legislators ask CDRH to review its CDS assistance

Health and Mediacal
In a letter to Dr. Michelle Tarver, recently selected director of the Center for Devices and Radiological Health, a department of the Food and Drug Administration, 7 members of Congress have actually asked the company to clarify assistance that followed 21st Century Cures Act exemptions for scientific choice assistance from policy as medical gadgets. "FDA's assistance does not show its normal risk-based method or think about the substantial medical oversight under which these tools are set up," they stated Tuesday. WHY IT MATTERS Congress excused CDS from guideline as medical gadgets, supplied they satisfy particular requirements, however legislators, led by Dan Crenshaw, R-Texas, and Ann McLane Kuster, D-N.H., offer clear guidance. "The FDA appears to note internally irregular examples of...
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Apr62024 by adminNo Comments
Pressing forward with information exchange at the Interoperability & HIE Forum

Pressing forward with information exchange at the Interoperability & HIE Forum

Health and Mediacal
Participants at HIMSS24 next week can home in on health info exchange concerns with the day-long Interoperability & & HIE Forum occurring Monday, March 11, in Orlando, Florida. Hosted by HIMSS Senior Director of Connected Health Rob Havasy, there are a number of essential focuses of the online forum this year. Amongst them: Trusted Exchange Framework and Common Agreement (TEFCA), which intends to develop a typical arrangement for sharing health info digitally throughout various health info networks. Of specific significance is the awaited introduction of Qualified Health Information Networks, or QHINs. The online forum will explore the performances of these networks within their structures and their approaches of exchanging info, intending to gear up individuals with the understanding requ...
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