Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more
On January 22, the Departments of Labor, Treasury, and Health and Human Services (“Tri-Agencies”) issued a set of Frequently Asked Questions (“ACA FAQs Part 64”) clarifying the contraceptive-related services that plans and...more
2019 saw court hearings of a number of cases related to the Affordable Care Act (ACA). Several other Trump administration policies were also challenged, including Medicare payment policies, price transparency, how the...more
The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more
Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more
The decision by the United States Supreme Court on same-sex marriage has been greeted with praise and disdain by different corners of the country. The faith-based community has been especially outspoken. This is not...more
The Departments of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued guidance in the form of FAQs on the ACA’s preventive services mandate. The ACA requires non-grandfathered...more
As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e....more
The Affordable Care Act (“ACA”) requires that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments). The Department of...more
In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives ...more
The Patient Protection and Affordable Care Act (ACA) requires certain employers to cover women’s preventive health care under their nongrandfathered group health plans at no cost to employees. The U.S. Department of Health...more
In This Issue: - Hobby Lobby decision further complicates ACA implementation - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State...more
Burwell v. Hobby Lobby: Regulations issued by the U.S. Department of Health and Human Services under the Affordable Care Act required that employers provide coverage for 20 contraceptive methods approved by the Food and Drug...more
As has been widely covered in the news, regulations and guidance developed under the Affordable Care Act (“ACA”) require that non-grandfathered health plans make preventive care and screenings available to their members at no...more
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food...more
In This Issue: - Top News ..Obama Administration Delays Employer Mandate One Year ..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix ..CMS Proposes Payment Changes for Medicare...more
Today federal regulators released additional guidance on the Affordable Care Act’s preventative care requirements for non-grandfathered plans, including additional information on contraceptive coverage. ...more
In This Issue: - Top News ..CMS Announces Round 2 Competitive Bidding Single Payment Amounts ..CBO Lowers SGR Repeal Cost by $100 Billion ..Republicans Press HRSA on 340B Audits ..HHS Proposes...more