Wednesday, March 30, 2016

PhRMA takes Cures Act to the Hill

Drug industry is going straight to Capital Hill to meet with lawmakers in hopes to curve the discussion and set precedence instead of a wait-and-see approach that only leads to contentious debates.  Leading the charge while the Senate ponders the FDA reform bill called 21st Century Cures is PhRMA's CEO.  The Act could be a ground breaking approach to a Pharmaceutical industry plagued with price gauging and notorious leadership that has come into question.  Steve Ubl, CEO PhRMA intends on having both scientists and patients speak directly with lawmakers in hopes to shape emanate policy making.
The 30K view of Cures is focused on medical innovation, FDA approval process and new drug….so topics around exempt reprints and reference text related to Sunshine Act (reversing some CMS rule), extension of FDAMA 114 for manufacturers communication with scientific developments, FDA new development guidelines and reversal of some FDA regulation on social media.  For specifics, turn to docs.house.gov
For IT, Healthcare vendors will notice downstream affects from HIPAA related to upgraded and compliance to practice management software including:




  • Fax machine (like Mainframes) - lingering deployment so added tracking and security will be required
  • Security training - updates programs / procedures and mandatory awareness training 
  • Access control - increased protection of PHI including audits and proactive account management
  • Physical security - facility and equipment room security protection, badges and key codes
  • And, all this with increase healthcare data access

No comments:

Post a Comment