INSIDE THIS ISSUE: 21st Century Cures 1 Did You Know? 3 Midwest Division Provider Update JANUARY 2017 VOLUME 2 ISSUE 1 CONTACT US: For suggesons or submissions, contact [email protected]This newsleer is intended solely as a communicaons modality and should not be considered to be an official publicaon of HHS or CMS federal register posting of devices that will be exempt from class I and II report- ing requirements. “Sensible oversight for technology which advances regulatory efficiency” looks at improving e-systems. This section clearly states it purpose is to address administra- tive, operational, laboratory, financial and workflow systems and clearly states it is not related to software for devices that directly impact patient care. It is not intended to influence treatment recommendations but is to support clini- cians. The Health Information Technology must be secure, provide full access to health information and The Act specifically notes “no information blocking.” Vendors that offer systems to providers need to ensure these requirements are met and provider purchasers need to “rigorously” test the system. The CMS Administrator is to provide in- formation regarding telemedicine. Specif- ically, beneficiaries, including dual eligi- bles, that could benefit from telemedicine to manage chronic conditions. (Continued on page 2) Signed into law on December 13 th , The Act “to accelerate the discovery, development, and delivery of 21 st century cures, and for other purposes” is retrievable from https:// www.congress.gov/bill/114th-congress/house- bill/6. Although the bulk of the law targets NIH and FDA, some of the provisions cross programmatic lines. Some of the notable men- tions are below. To streamline the approval process for some new drugs, an expedited approval is now optional. Consideration for approval will take into account medications de- signed to target urgent needs, such as ill- nesses or conditions that are severe, rare, highly prevalent or without suitable treat- ment alternatives. Antibiotic stewardship to monitor use of antibacterial and antifungal medications and tracking of resistance, with the results of the data to be made publically available FDA to “ease regulatory burden” on class I and II devices. Not sure what those are? You can conduct a datamining expedition at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Overview/ ClassifyYourDevice/ucm051530.htm or just wait a month or so for the required
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Midwest Division Provider Updateweb.mhanet.com/Regulatory/January 2017.pdf · 2017-01-09 · INSIDE THIS ISSUE: 21st Century Cures 1 Did You Know? 3 Midwest Division Provider Update
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