Melissa Levine

Jan 9, 2024 | lexology.com | Heidi Forster Gertner |Melissa Bianchi |Robert Church |Melissa Levine |Blake Wilson

The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which permits an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects.

Jun 7, 2023 | lexology.com | Scott Loughlin |Marcy Wilder |Melissa Bianchi |Melissa Levine

Click here to watch the videoUse of health data in connection with U.S. marketing activities is complex. While regulation on the use of health data for marketing is not new, lawmakers, regulators, and law enforcement have increasingly focused on how companies are using sensitive data for advertising and marketing.

Apr 18, 2023 | jdsupra.com | Melissa Bianchi |Melissa Levine |Marcy Wilder

Authorization. As with the use of genetic information for underwriting purposes, HHS proposes to prohibit the use of a HIPAA authorization to enable a HIPAA-regulated entity to use or disclose PHI for the Prohibited Purposes. In other words, an authorization may not be used to override the prohibition on prohibited uses and disclosures. This ensures an individual is not coerced into signing an authorization. Adding Definition of Public Health.

Apr 17, 2023 | lexology.com | Marcy Wilder |Melissa Bianchi |Melissa Levine

The U.S. Department of Health and Human Services (“HHS”) is proposing changes to HIPAA that would increase protections for reproductive health care information. If finalized, these changes would prohibit HIPAA-regulated entities from using or disclosing protected health information (“PHI”) to support the investigation or prosecution of patients and providers involved in obtaining or providing legal reproductive healthcare. The NPRM comes in the wake of the Supreme Court decision (Dobbs v.