Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Predictions regarding the 2023 CRA Rule and Section 1071 and how to prepare for expected developments
Consumer Finance Monitor Podcast Episode: Everything You Want to Know About the CFPB as Things Stand Today, and Lots More - Part 1
FCPA Compliance Report: Death of CTA
2024 Payments Year in Review: CFPB and FTC Regulatory Trends – Part One — Payments Pros – The Payments Law Podcast
Consumer Finance Monitor Podcast Episode: Alan Kaplinsky’s “Fireside Chat” with Former CFPB Leader David Silberman: His Experience During the Prior Transition from the Obama Administration to Trump
SBA’s Final Rule Is Here: Key Takeaways on Updates to HUBZone Program, Other Small Business Programs, and Various Small Business Matters
Hidden Fees in the Live-Event Ticketing and Short-Term Lodging Industries
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Director Review Under the USPTO's Final Rule – Patents: Post-Grant Podcast
#WorkforceWednesday®: After the Block - What’s Next for Employers and Non-Competes? - Spilling Secrets Podcast - Employment Law This Week®
Employment Law Now VIII-150 - The FTC Noncompete Rule is Dead: What Now?
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Sustainable Procurement: A Closer Look at the New Federal Acquisition Regulation (FAR)
Employment Law Now VIII-145 – Status Update: Injunctions for FTC Non-Compete Ban and DOL Overtime Exemption Regs
Legal Alert | Reign It In: Federal Court Enjoins DOL's Expansion of Davis-Bacon Coverage
Consumer Finance Monitor Podcast Episode: What Banking Leaders Need to Know About the U.S. Supreme Court Ruling That the CFPB’s Funding Mechanism is Constitutional Part I
Unpacking FERC's Transmission Planning and Permitting Final Rules
The Burr Broadcast: Key Differences Between PWFA and ADA
DOL’s Expanded Overtime Salary Limits, EEOC’s Sexual Harassment Guidance, NY’s Mandatory Paid Prenatal Leave - Employment Law This Week®
On December 17, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more
On June 24, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the 21st...more
On July 1, 2024, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) published a final rule in...more
Last week, HHS published its final rule outlining disincentives for certain healthcare providers that have committed information blocking (the Final Rule). The Final Rule also provides information related to OIG’s...more
The United States Department of Health and Human Services (HHS) has now established disincentives for certain health care providers if found by the Office of Inspector General (OIG) to have committed information blocking...more
The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) published its Health Data, Technology, and Interoperability: Certification Program Updates,...more
On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more
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
As of September 1, 2023, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) can officially begin enforcement against Certified Health Information Technology (“HIT”) developers, health...more
The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more
On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more
On June 27th, Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) posted its final rule (Final Rule), which amends the OIG’s civil monetary penalty (CMP) regulations to implement the...more
Federal enforcement of the 21st Century Cures Act’s (the Cures Act) prohibitions on improper blocking of electronic health information is ramping up. The Cures Act already targets technology developers and health information...more
The Office of the National Coordinator for Health Information Technology (ONC) published noteworthy information blocking claim submission trends to date in its recent Information Blocking Claims: By the Numbers post on the...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more
On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more
Report on Patient Privacy 20, no. 11 (November 2020) - HHS Office of the National Coordinator (ONC) for Health Information Technology (ONC) is giving health care organizations more time to meet new rules on information...more
On October 29, 2020, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health IT (ONC) released an interim final rule with comment period that extends the compliance dates and...more
Healthcare providers focusing on COVID-19 may have missed the final Interoperability and Information Blocking Rule that was published May 1, 2020 and takes effect November 3, 2020. (45 C.F.R. Part 171). The Rule implements...more
Compliance Today (May 2020) - The U.S. Department of Health and Human Services (HHS) announced in a March 9, 2020, news release that it had “finalized two transformative rules that will give patients unprecedented safe,...more
On March 9, 2020, the Department of Health and Human Services (HHS) published two major regulations that will give patients additional access to their health data, while also addressing security of that information. Health...more
On March 9, 2020, two final rules on electronic health information were issued by the Office of National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS)....more
In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research...more
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more