The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more
In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
2/25/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Telehealth ,
Telemedicine
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more
7/9/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Immunity ,
Product Defects ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Risk Mitigation ,
Suppliers ,
Supply Chain ,
Telehealth
Blockchain continues its buzz in healthcare for its potential to revolutionize patient records, medical data, medical billing, and wearable device use. Healthcare stakeholders may consider using this technology to advance...more
The Agency shows no signs of slowing regulatory activity.
Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
9/1/2016
/ Advisory Committee ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Diagnostic Tests ,
Enforcement Actions ,
Final Guidance ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Investigational Device Exemptions ,
Medicaid ,
Medical Devices ,
Medicare ,
Patient-Specific ,
Provider Payments ,
Unique Device Identifiers ,
Validity
The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more