DOH

DOH Finalizes Temporary Regulations for Clinical Registrants and Academic Clinical Research Centers

Posted by J. Nicole Martin on March 16, 2018
PA Medical Marijuana Program / No Comments

The Pennsylvania Department of Health (DOH) published the much anticipated final version of the temporary regulations under the Medical Marijuana Act applicable to Clinical Registrants and Academic Clinical Research Centers (ACRC) in Pennsylvania (“Temporary Regulations”). The Clinical Registrant/ACRC relationship was first developed in Pennsylvania with a specific focus on research.  A Clinical Registrant is a unique category of Medical Marijuana Organization under Pennsylvania law that is granted a permit to act as both a grower/processor and dispensary. An ACRC is “an accredited medical school” in Pennsylvania that “operates or partners with an acute care hospital licensed and operating” in Pennsylvania. The Temporary Regulations require Clinical Registrants and ACRCs to enter into Research Contracts together and provide some broad guidance about the content of those written agreements. Additionally, the Temporary Regulations address certification of ACRCs, capital requirements, approvals for clinical registrants, and the process for Clinical Registrant applicants who wish to convert their already issued grower/processor or dispensary permits to Clinical Registrant permits.

For more information about the Temporary Regulations or the Medical Marijuana Act, contact Chris Raphaely, J. Nicole Martin or another member of Cozen O’Connor’s Cannabis Industry Team.

J. Nicole Martin

J. Nicole Martin

Nicole assists accountable care organizations, health care systems, long term care providers (e.g., skilled nursing facilities, continuing care retirement communities), behavioral and mental health providers, medical device manufacturers, physician practices, and pharmacies with their compliance, regulatory, and transactional needs. Nicole’s practice includes providing clients with counsel regarding telehealth laws, HIPAA/HITECH and state privacy and security laws, data breaches, business associate and covered entity obligations, licensure laws, Medicare, Medicaid and third-party payer matters, medical staff issues, and fraud and abuse laws.

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PA DOH Releases Proposed Temporary Medical Marijuana Regulations for Doctors

Posted by J. Nicole Martin on April 12, 2017
DOH, PA Medical Marijuana Program / No Comments

Yesterday the Department of Health (DOH) released the much anticipated proposed temporary regulations for physicians that among other items, set forth requirements regarding: the physician registry, the completion by physicians of a four-hour training course, and issuing patient certifications, as well as prohibitions, including for example, a prohibition against advertising a physician’s ability to prescribe cannabis under the Pennsylvania Medical Marijuana Act (Act 16). As the proposed regulations are not yet effective, DOH will accept comments on them until April 20, 2017. More information about these draft regulations appears on the DOH website, and they are available here.

J. Nicole Martin

J. Nicole Martin

Nicole assists accountable care organizations, health care systems, long term care providers (e.g., skilled nursing facilities, continuing care retirement communities), behavioral and mental health providers, medical device manufacturers, physician practices, and pharmacies with their compliance, regulatory, and transactional needs. Nicole’s practice includes providing clients with counsel regarding telehealth laws, HIPAA/HITECH and state privacy and security laws, data breaches, business associate and covered entity obligations, licensure laws, Medicare, Medicaid and third-party payer matters, medical staff issues, and fraud and abuse laws.

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