AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more
The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more
On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more
On the back of the 2016 United States presidential election results, the health care industry ponders how a Republican president and Congress will transform the business environment. The health care industry has a number of...more
On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more
This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more
This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more
This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more
This Week: Leading Up to the SCOTUS King v. Burwell Decision... House Votes to Repeal the Medical Device Tax... CMS Announces It Will Bolster Transitional Reinsurance Payments... MedPAC Releases June Report to Congress....more
This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more
This Week: House E&C 21st Century Cures Bill Passes Unanimously Out of Committee... House Votes to Codify Permanent R&D Tax Credit... CMS Released Proposed Rule Concerning Medicaid and CHIP Plans....more
In This Issue: - 21st Century Cures Markup; Full Committee to Take Up this Week - Senate Finance Committee Solicits Health Bills for Upcoming Markup - Implementation of the Affordable Care Act - Federal...more
This Week: Health Subcommittee Advances 21st Century Cures, Full Committee Action Scheduled…Senate Finance Committee Hearing: Chair Hatch to Launch New Initiative on Improving Chronic Care for Medicare Patients…Hawaii’s...more
This Week: Energy and Commerce Health Subcommittee Explores Post-Acute Bundling…CMS Releases First-ever Hospital Compare Star Ratings…Fiscal Year 2016 Proposed Inpatient and Long-term Care Hospital Policy and Payment Changes....more
In This Issue: - King v. Burwell before the Supreme Court and the Potential Congressional Response - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Congressional...more
On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more
It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more
CMS Releases Proposed Rule on Prior Authorizations for DMEPOS Items – On May 22, 2014, CMS released a Proposed Rule setting out a prior authorization process for certain types durable medical equipment, prosthetics,...more
Congress held several hearings last week ranging from Sylvia Burwell’s nomination for Secretary of the Department of Health and Human Services (HHS), to Medicare payment oversight, to post-acute care in Medicare. The Centers...more
CMS recently took the unusual step of issuing an Advance Notice of Proposed Rulemaking (ANPR) regarding changes to Medicare payment methodologies for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)...more
In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more
In This Issue: - Top News ..Deal to Raise Debt Ceiling, End Shutdown Yields No Major Changes to Health Care Law ..Problems with HealthCare.gov Website Continue; HHS Working to Fix Issues ..Kaiser Study...more
Data collection requirements under the Physician Payment Sunshine Act commenced August 1, 2013. This provision of the Patient Protection and Affordable Care Act and the corresponding regulations require an entity that is...more
As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more