Law360 included insights from McGuireWoods healthcare partners Craig Bleifer and Jennifer Shanley in a Jan. 1, 2025, story on healthcare and life sciences policies to watch in the year ahead.
Bleifer commented on potential changes to the Inflation Reduction Act’s (IRA’s) drug price negotiation program under the new Trump administration. Bleifer said a complete repeal of the program is unlikely because of public support for lowering drug prices, making it “more likely that we will see tweaks to the statute and its implementation in the Trump administration.”
The changes could include proposals to expand the program to include more drugs or subject them to earlier price control measures, he added.
“A major change would be the sort of proposal floated by the Biden administration to extend IRA’s price controls to all private insurance since it only covers federally-funded drug benefits — this also has significant popular appeal and could become part of the new Republican agenda,” said Bleifer, former general counsel at global pharmaceutical companies Novo Nordisk and Daiichi Sankyo.
Shanley discussed the anticipated release of the Health Insurance Portability and Accountability Act’s security rule, which is expected to clarify what companies must do during risk analyses, including identifying and addressing network vulnerabilities. Such pre-breach efforts are critical to protecting public health information (PHI), she said.
“The rise of ransomware attacks targeting the healthcare industry is not to be ignored, and healthcare organizations must take responsible measures to protect PHI,” said Shanley, a member of McGuireWoods’ digital health and technology team.
“There also has been notable collaboration between HHS and [the National Institute of Standards and Technology], and I anticipate further incorporation of NIST’s security standards into the HIPAA security rule,” she added.
Shanley said she expects federal efforts to update HIPAA and protect health information will continue in the second Trump administration.
“It is difficult to anticipate how the new administration will respond given that none of the specific updates are yet known,” she said. “However, there tends to be bipartisan support for strengthening cybersecurity measures, including protecting the security of individual health information.”