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Health Law Consulting Blog

Sunday, June 17, 2018

HIPAA and HITECH Act Issues for Pharma Companies and Technology Initiatives

It is common knowledge that a covered entity and business associate as defined by HIPAA must comply with HIPAA and HITECH Act requirements. Since the HITECH Act, requests are made of pharmaceutical drug makers (“Pharma Company”) to enter BAAs, particularly in connection with the company’s technology and technology-enabled initiatives. We caution against any Pharma Company jumping into a BAA with a technology vendor, if the Pharma Company or technology vendor each are not already a BAA or sub-BAA, without giving careful thought to whether this makes sense for either or both.

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Some considerations for a Pharma Company when presented with a request to enter a BAA or sub-BAA with a technology vendor:

  • Is the Pharma Company directly implicated under HIPAA?  If so, how?
  • How might a Pharma Company become subject to HIPAA?
  • Has the Pharma Company with an HCP (or other CE) conceded such authority? If yes, then it must enter a BAA and/or sub-BAAs.

Disclaimer: The information in this blog post (“Post”) is provided for general informational purposes only, and may not reflect the current law in your jurisdiction. No information contained in this post should be construed as legal advice from Faulk & Associates, LLC or the individual author, nor is it intended to be a substitute for legal counsel on any subject matter. No reader of this Post should act or refrain from acting on the basis of any information included in, or accessible through, this Post without seeking the appropriate legal or other professional advice on the particular facts and circumstances at issue from a lawyer licensed in the recipient’s state, country or other appropriate licensing jurisdiction.





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