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
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...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
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
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
General and specialty compliance education from the comfort of your home or office - HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance learning that covers a wide variety of...more
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education, including updates on the latest news in regulatory...more
General and specialty compliance training from the comfort of your home or office! HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance training that includes updates on the...more
Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...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
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more
On May 1, 2020, the Office of the National Coordinator for Health Information Technology (“ONC”) published its final rule, commonly referred to as the “Information Blocking Rule,” implementing certain provisions of the 21st...more
Monday, April 5th, marked the deadline for compliance with the information blocking regulations implemented by the Office of the National Coordinator for Health IT (ONC). As a follow-up to our earlier FAQs on these new...more
The 21st Century Cures Act (Act) and a recently adopted final rule by the Office of the National Coordinator for Health Information Technology (ONC) in the U.S. Department of Health and Human Services will now prohibit...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
On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more
The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more
On March 4, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a wide-ranging proposed rule (“Proposed Rule”) with the intent to “move the health care ecosystem in the direction of interoperability” in...more
The ONC finally released its long-awaited proposed rule to implement the “information blocking” prohibition of the 21st Century Cures Act by identifying conduct that is not information blocking. If finalized, ONC’s proposed...more
• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions. • The...more