- Posts by Marylana Saadeh HelouMember of the Firm
Attorney Marylana Saadeh Helou focuses her practice on advising academic medical centers, hospitals, universities, pharmaceutical and medical device companies, digital health companies, and other health care technology ...
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...
On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]
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Recent Updates
- Podcast: Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
- Unpacking Averages: How Old Are Medical Devices on the US Market?
- Three Things That Employer Health Plan Sponsors Should Do When the New MHPAEA Rules Are Published
- CMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin Supplements and More; Comments Due September 9
- Recent Supreme Court Decisions and the DSCSA