FDA Law Blog - HHS Issues Refill Reminders Guidance Ahead of Compliance Deadline; FDA’s Fifth Annual Report to Congress on 505(q) Citizen Petitions

By Jeffrey N. Wasserstein & Alexander J. Varond –

Last week, ahead of the September 23, 2013 compliance deadline for its HITECH final rule (also referred to as the “Omnibus Final Rule”), the Department of Health and Human Services issued guidance  entitled “The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual.”  In prior posts, we discussed the HITECH final rulehere, here, and here.  The guidance, as you guessed it, addresses the refill reminder exception, from the Omnibus Final Rule, and its two prongs:  (1) whether the communication is about a “currently prescribed drug or biologic,” and (2) if the communication involves financial