Expanded Information Block Rules Go into Effect
Podcast: Interoperability: The Provider Perspective - Diagnosing Health Care
Podcast–Interoperability: How Far We’ve Come and Where We’re Going - Diagnosing Health Care
The New Information Blocking Rule: What It Means For Hospices
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
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 December 13, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued the Health Data, Technology, and Interoperability: Certification...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 July 3, 2023, OIG published its final enforcement rule (the OIG Rule) permitting imposition of civil monetary penalties (CMPs) for certain actors that engage in information blocking in violation of the 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
On March 2019, the Office of the National Coordinator for Health Information Technology (ONC) issued a Proposed Rule, 21st Century Cures Act: Interoperability, Information Blocking and the ONC Health Information Certification...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
As of April 5, 2021, health information technology companies and developers are required to comply with the information blocking provisions of the Centers for Medicare and Medicaid Services’ (CMS) and the Office of the...more
On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products. This final rule takes...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
CMS made impactful changes to the Federal physician self-referral law’s (i.e., Stark Law’s) regulations in its Final Rule that were effective January 19, 2021 (with the exception of the changes to 42 C.F.R. § 411.352(i) that...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
Aimed at enabling greater patient access and mandating interoperability, recent Final Rules from the Office of the National Coordinator for Health IT (“ONC”) and the Centers for Medicare and Medicaid Services (“CMS”) have put...more