This is the second in our series on provisions of the HHS proposed rule implementing the HITECH Act that, if included in the final rule, are likely to have the greatest impact on the business operations of pharmaceutical and other life sciences companies.  We previously covered HHS’s proposed treatment of refill reminders and other communications about currently prescribed drugs.  HHS has indicated that the final rule will be issued in March.

Today, we will look at the new requirements contained in the HHS proposed rule issued last July for what HHS is calling “remunerated treatment communications.” 

Remunerated Treatment Communications

The HIPAA Privacy Rule generally requires that a covered entity obtain prior written authorization from an individual before using that individual’s protected health information for marketing purposes.  Prior to the HITECH Act, certain communications, including those related to treatment and care coordination, were excluded from the definition of marketing.  But under the HITECH Act, if a covered entity or business associate is compensated by a third party for making certain communications (including those related to treatment and care coordination), the covered entity generally must obtain prior authorization.  As we previously reported, the HITECH Act contains one limited exception for communications about currently-prescribed drugs.

Continue Reading HIPAA/HITECH Regulations are Coming: What do Pharmaceutical Companies Need to Know? (Part 2 of 5)

As we previously reported, the Office for Civil Rights within the Department of Health and Human Services (HHS) has indicated that the final rule implementing changes to the HIPAA regulations under the HITECH Act will be issued in March.  The proposed rule, released last July, contains sweeping changes to the privacy, security, and enforcement rules promulgated under HIPAA.  In this and four subsequent blog posts, we will explore aspects of the proposed rule relating to marketing, clinical research, and the sale of protected health information.  These changes, if included in the final rule, are likely to have the greatest impact on the business operations of pharmaceutical and other life sciences companies.  (Although generally not regulated under HIPAA directly, such companies often have arrangements with entities that are covered entities or business associates under HIPAA.)

Communications About Currently Prescribed Drugs

The first topic we will address is HHS’s proposed treatment of refill reminders and other communications about currently prescribed drugs.  The HIPAA Privacy Rule generally requires that a covered entity obtain prior written authorization from an individual before using that individual’s protected health information for marketing purposes.  Prior to the HITECH Act, certain communications, including those related to treatment and care coordination, were excluded from the definition of marketing.  But under the HITECH Act, if a covered entity or business associate is compensated by a third party for making certain communications (including those related to treatment and care coordination), the covered entity generally must obtain prior authorization.

Continue Reading HIPAA/HITECH Regulations are Coming: What do Pharmaceutical Companies Need to Know? (Part 1 of 5)