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.
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