Sheridan Organ

Jan 17, 2025 | mondaq.com | Alexandra Shalom |Lawrence W. Vernaglia |Ilana Meyer |Sheridan Organ

On January 8, 2025, Governor Maura Healey signed into law H.B. 5159, "an Act enhancing themarket review process." This new law promises sweepingreform to reshape how health care businesses operate and grow. Withstricter oversight, expanded reporting obligations, and newlicensing requirements, the legislation signals an uptick inregulatory oversight of health care transactions and operations inMassachusetts. These changes have wide-ranging implications forstakeholders across the health care space.

Jan 15, 2025 | jdsupra.com | Ilana Meyer |Sheridan Organ |Alexandra Shalom

On January 8, 2025, Governor Maura Healey signed into law H.B. 5159, “an Act enhancing the market review process.” This new law promises sweeping reform to reshape how health care businesses operate and grow. With stricter oversight, expanded reporting obligations, and new licensing requirements, the legislation signals an uptick in regulatory oversight of health care transactions and operations in Massachusetts.

Jan 7, 2025 | jdsupra.com | Nathan Beaver |Kyle Faget |Sheridan Organ

On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions (AI-DFS) final guidance document (“PCCP Guidance” or “final guidance”). The final guidance discusses the scope of applicability of PCCPs, policy behind PCCPs, and the major components necessary to include in submissions for PCCP approval.