Key Takeaway: As healthcare takes center stage in the 115th Congress, the House Republican Study Committee released their plan to repeal and replace the Affordable Care Act (ACA) last week.
Why It Matters: Among top priorities for both the incoming President and Republican Congress leadership is to repeal and replace the Affordable Care Act.
Many repeal and replace proposals have been floating around Congress since the passage of the ACA, including that from House Speaker Paul Ryan, who unveiled the “Better Way” proposal in 2016.
On January 4, 2017, the House Republican Study Committee, led by Mark Walker (R-NC) released the American Health Reform Act (AHRA) would fully repeal the ACA. The RSC plan varies from the plan released by Speaker Paul Ryan (R-WI), the so-called “Better Way” proposal uses tax credits while the AHRA would convert tax deductions into an above-the-line standard deduction for health insurance. Individuals with qualifying plans will receive a $7,500 deduction while families would receive a $20,500 deduction under AHRA.
There is currently no timeline for the replacement portion of the legislation.
Cyber & HIPAA Update
Key Takeaway: FDA announced final cybersecurity guidance for manufacturers.
Why it Matters: Around this time last year the FDA released draft guidance detailing the steps they expect (but do not mandate) manufacturers should take in securing medical devices. CHIME and AEHIS responded by submitting comments. The FDA released the final guidance on December 28th, 2016. The guidance in many cases remains similar to the draft guidance, however, they do appear to place a stronger emphasis on patient safety and calling for manufacturers to adhere to stipulations for “uncontrolled risks”, that is, risks that pose significant issues to patient safety. The FDA however, rejected the notion that privacy issues can be a contributing factor to patient safety for the purposes of this guidance. They also added a new section focusing on ISAOs. CHIME has put together a chart detailing what FDA expects of manufacturers when it comes to securing devices which you can find here.
Bipartisan House Internet of Things (IoT) Working Group
Key Takeaway: The bipartisan House Internet of Things (IoT) Working Group released a year-end paper that included coverage of how healthcare is impacted by the rapid shift to IoT.
Why It Matters: Congress held a number of hearings and roundtables in 2016 outlining the challenges and opportunities posed by the IoT, including a hearing held by the House Committee on Energy and Commerce for which CHIME submitted comments.
The Working Group was led by Representatives Bob Latta (R-OH) and Peter Welch (D-VT), formed with the intention of educating members of Congress about the many opportunity and challenges posed by the internet of things. The working group held a healthcare-focused roundtable that included conversation on interoperability challenges that are impeding improved patient care. The roundtable also featured concerns about privacy and security, and the complexity of data security in IoT world. The working group’s paper notes that among the recommendations discussed at the healthcare roundtable was that the industry should seek to limit vulnerabilities by developing software and devices with security in-mind rather than solely based on functionality.
Key Takeaway: The Federal Trade Commission (FTC) takes action involving medical devices.
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