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Arkansas Restricts PBM Ownership of Pharmacies and Limits Manufacturers’ Use of Limited Distribution Networks

On April 16, Arkansas Governor Sarah Huckabee Sanders signed into law HB1150 and HB1531, two significant pieces of legislation affecting pharmacy benefit managers (PBMs) and pharmaceutical manufacturers operating within the...more

Proposed Rulemaking to Strengthen HIPAA Security Rule

On January 6, the Department of Health and Human Services Office for Civil Rights (OCR) published a notice of proposed rulemaking (Proposed Rule) that would strengthen the requirements of the security rule promulgated...more

HHS Releases Cybersecurity Performance Goals for Healthcare Organizations

In response to the number of successful, large-scale ransomware attacks affecting healthcare organizations nearly tripling since 2018, the Department of Health and Human Services (HHS) has released guidance outlining its...more

FDA Guidance on Diversity Plans in Clinical Trials: What You Need to Know

The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more

Healthcare Transactions Q1 2022

2022 started strong for healthcare transactions with some reports suggesting a record-breaking January. Although deal activity cooled in February and March, transaction pipelines still indicate that 2022 is on pace to match...more

OCR Settlement Underscores the Importance of HIPAA Privacy and Security Review in Transactional Due Diligence

On April 28, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) entered into a resolution agreement with Peachstate Health Management, LLC, doing business as AEON Clinical Laboratories...more

NIH Begins Implementation of OSTP Foreign Influence Recommendations for Research Institutions

As part of the government’s broader efforts to combat foreign threats to U.S.-funded scientific research, the National Institutes of Health (NIH) and White House Office of Science and Technology Policy (OSTP) have announced...more

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