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Photo of Posts by Andrea L. Frey Andrea L. Frey
Associate
afrey@health-law.com
415.875.8507
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Showing 5 posts by Andrea L. Frey.

On October 24, 2018, President Trump signed into law the bipartisan SUPPORT for Patients and Communities Act (H.R. 6 or the “Act”), which aims to combat opioid abuse with increased attention to treatment. The wide-reaching compromise legislation combines elements from a number of opioid bills, addressing issues from access to treatment and prevention programs to expanded law enforcement efforts to curtail drug trafficking. The Act, however, does omit several items that have been part of the national dialogue on opioid abuse. For example, it does not include amendments to 42 U.S.C. § 290dd-2 and the associated regulation at 42 C.F.R. Part 2 (“Part 2”) that would align the Part 2 substance use treatment privacy law with the Health Insurance Portability and Accountability Act (“HIPAA”) privacy rules to better facilitate the sharing of a patient’s substance use disorder information among providers. In addition, the Act does not provide for a significant increase in spending for the opioid crisis. Read More ›

Mandatory CURES Consultation Effective October 2

Beginning October 2, 2018, California health care professionals authorized to prescribe, order, administer or furnish controlled substances must consult the state’s prescription drug monitoring database (the Controlled Substance Utilization Review and Evaluation System, or CURES) prior to prescribing, ordering, administering or furnishing Schedule II-IV controlled substances, unless an exemption applies.[1]  The duty to consult takes effect almost two years after the law was initially enacted, and six months after the California Department of Justice (DOJ) certified CURES as ready for statewide use. Read More ›

On July 25, 2018, the Office for Human Research Protections (OHRP) announced the availability of three draft guidance documents related to implementation of three burden-reducing provisions of the revised Federal Policy for the Protection of Human Subjects (Revised Common Rule). Read More ›

The Substance Abuse and Mental Health Services Administration (SAMHSA), part of the U.S. Department of Health and Human Services (HHS), issued a final rule on January 3, 2018 to the federal regulations governing the confidentiality of health information in federally-assisted substance use disorder (SUD) programs, found in 42 CFR Part 2 and known as “Part 2.” Read More ›

Federal Agencies Issue Revised Common Rule

The sixteen federal agencies responsible for protecting human subjects of federally-funded research issued a final rule to modernize the Federal Policy for the Protection of Human Subjects on January 19, 2017 - the last day of the outgoing Administration. This is the first comprehensive overhaul of the so-called "Common Rule," which was issued in 1991 to create a uniform set of standards governing federally funded or sponsored research involving human subjects. Read More ›

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