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
This week on the American Bar Association’s Our Curious Amalgam podcast, co-hosts Jeny Maier, Managing Partner at Axinn, Veltrop & Harkrider, and Matt Tabas, Antitrust & Competition Partner at Arnold & Porter, are joined by...more
On June 31, 2024, the Department of Health and Human Services (“HHS”) published a final rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century Cures...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
Speaking at CES 2024 earlier this year, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf expressed significant concerns about the FDA’s ability to effectively regulate artificial intelligence (AI) in the...more
On October 30, 2023, the Department of Health and Human Services (HHS) released a proposed rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century...more
In 2020, when the U.S. Department of Health and Human Services (HHS) published its Final Rule to implement the information blocking prohibitions of the 21st Century Cures Act, HHS left healthcare providers wondering what...more
While health care providers have been required to comply with the 21st Century Cures Act Information Blocking Rule (the Rule) since April 5, 2021, as of yet there is no enforcement mechanism in place with respect to the Rule...more
On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information...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
Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...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
The health care industry is increasingly adopting mobile apps for a variety of purposes, including tracking patient health conditions and sharing patient data. Privacy and security are important considerations, and it is...more
Health care providers subject to the Information Blocking rules issued under the 21st Century Cures Act, Pub.L. 114–255, are reminded that such Information Blocking rules will apply to an expanded set of information beginning...more
The 21st Century Cures Act directed the National Coordinator to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.” Fulfilling that mandate, the Office...more
On February 28, 2022, the Office of the National Coordinator for Health Information Technology (ONC) issued data on information blocking claims received since April 5, 2021, the effective date of information blocking...more
The Office of the National Coordinator for Health Information Technology recently released a final rule under the 21st Century Cures Act to promote interoperability of health IT and advance access, exchange or use of...more
Federal regulators are flexing their regulatory muscle to accelerate a long-desired but often elusive goal: the interoperability of health information technology (health IT) systems. Interoperability refers to the ability of...more
On September 17, 2018, the federal Office of the National Coordinator for Health Information Technology (ONC) submitted proposed new rules to the Office of Management and Budget (OMB), entitled, “21st Century Cures Act:...more
On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more
On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more
A new section of the 21st Century Cures Act provides much-needed relief for hospitals with an off-campus provider-based department (off-campus PBD) that was mid-build or under development as of November 2, 2015 (the Mid-Build...more
The 21st Century Cures Act (Act), enacted in December 2016, has received widespread coverage for funding biomedical research and streamlining the drug approval process. The Act also includes the Helping Families in Mental...more
The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more