The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on integrating randomized controlled...more
The ability of OCR to enforce expansive portions of its controversial web tracking guidance has been severely limited. A federal district court ruled that the guidance exceeded the agency’s authority, and in particular...more
On May 30, 2024, the FTC published amendments to its Health Breach Notification Rule (“HBNR” or “Rule”) in the Federal Register, memorializing the Rule’s expanded scope that now explicitly includes direct-to-consumer health...more
The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination...more
On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness to adopt stakeholder suggestions...more
At our recent Health Care AI Law and Policy Summit, Hogan Lovells partner Melissa Bianchi moderated a panel discussion on the state of the health care AI industry. Joined by representatives from the American Medical...more
The Federal Trade Commission (FTC) recently has signaled its intent to inject new life into a longstanding but rarely triggered rule governing health breach notifications for non-HIPAA-covered health records. Specifically,...more
2/28/2022
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Digital Health ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Popular
A new Policy Statement from the US Federal Trade Commission places companies that offer consumer-facing health apps and connected health and wellness devices on notice that they may be covered by a Health Breach Notification...more
10/6/2021
/ American Recovery and Reinvestment Act ,
Application Programming Interface (APIs) ,
Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Mobile Health Apps ,
Policy Statement ,
Popular
Consent is newly defined by the California Privacy Rights Act (CPRA). While this new definition of consent—which highlights specific, informed, and freely-given actions—closely aligns with the European Union’s General Data...more
4/23/2021
/ California Privacy Rights Act (CPRA) ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Management ,
Data Privacy ,
Data Protection ,
General Data Protection Regulation (GDPR) ,
Information Governance ,
Personal Data ,
Popular ,
Prior Express Consent
On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations....more
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more
2/11/2019
/ Anti-Kickback Statute ,
Comment Period ,
Drug Pricing ,
Health Insurance ,
Incentives ,
Life Sciences ,
Managed Care Contracts ,
Medicaid ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Rebates ,
Regulatory Agenda ,
Safe Harbors ,
Trump Administration
Virtually all industries are being reshaped with the use of Artificial Intelligence and advanced machine-learning.
Everything from healthtech to self-driving vehicles, to education and smart homes, drones and space, social...more
4/4/2018
/ Antitrust Provisions ,
Artificial Intelligence ,
Asia Pacific ,
Connected Cars ,
Connected Items ,
Drones ,
Ethics ,
Export Controls ,
FinTech ,
Intellectual Property Protection ,
Life Sciences ,
Outer Space ,
Popular ,
Regulatory Oversight ,
Robotics ,
Satellites ,
Smart Devices ,
Unmanned Aircraft Systems