We had a really enjoyable Fast Break yesterday on a non-traditional health law topic: radioactive material regulation. As it turns out, nearly all hospitals and larger provider groups, particularly those doing imaging, oncology, or neurosurgery, routinely use or come into contact with regulated radioactive material. PET scans, for instance, which are operated by a significant number of hospitals, rely on radioactive isotopes as the basis of the imaging procedure. Our lawyers explained that providers are regulated by the Nuclear Regulatory Commission (NRC) and/or similar state-based agencies (called Agreement States). Each provider has to secure a specific license for use of radioactive materials, which entails designating a radiation safety officer and establishing a radiation safety plan.
What we found most interesting about the session was the similarity between nuclear material regulation and traditional healthcare compliance expectations. In addition to establishing a radiation safety plan (similar to a compliance plan) and designating an individual to be in charge of the program (similar to a compliance officer or HIPAA privacy/security officer), there are even whistleblower and anti-retaliation provisions that require nuclear material licensees to establish reporting mechanisms and ensuring that their employees feel safe to raise concerns about licensure compliance issues. Sounding familiar?
As you think about the risk profile for your organization and how to properly stay attuned to changing risk dynamics, it is important to think outside the box a bit. If you have legal or compliance responsibilities for an organization, it’s worthwhile to spend time understanding the organization’s various operations to see if you have the licenses you’re supposed to have and are complying with the terms of those licenses. Healthcare compliance is tricky enough as it is – don’t forget to assess compliance with non-traditional regulatory agencies!
Next month, we will sit down with Morgan Lewis partners Andy Ray and Jeff Bodle to discuss HealthTech Startups! Join us on April 25 at 3:00 pm.
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