QUESTION: My lab partner here in Texas has said that he has been told that labs do NOT have to sign business associate agreements, that they are acting on prescription from the doctor and are liable on their own, and therefore do not need the business associate agreement. I cannot tell from reading the training manuals, which include quoted text from the law, whether my lab technician partner is correct or not. I’m sure if I say I must have a business agreement or I will end our business relationship he will concede, however, I don’t want him to feel like he’s being extorted into signing.
ANSWER FROM LINDA HARVEY, RDH, MS, LHRM, Compliance/Risk Management Specialist:
The Final Omnibus Rule now defines business associates as individuals or entities who create, receive, maintain, or transmit protected health information (PHI) in such activities as insurance claims processing, data analysis, utilization review, quality assurance, and patient safety actions. This also includes your IT vendor, collection agency, and others. Still, many are confused about how to classify dental labs. Under the HIPAA guidelines, dental labs are classified as health-care providers, not business associates (45 CFR 164.502(e)). Even in light of the Final Rule, recipients of PHI for treatment-related purposes remain excluded from having to execute a Business Associate Agreement.
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