News & Analysis as of

Office of Civil Rights 21st Century Cures Act

McDermott Will & Emery

ASTP Adopts New Protecting Care Access Exception

McDermott Will & Emery on

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

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

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

Holland & Knight LLP

Reproductive Healthcare Privacy Rule Brings New Requirements for All Providers

Holland & Knight LLP on

In the midst of an industry reeling from the Change Healthcare cybersecurity incident, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has issued a series of final rules requiring...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - July 15th - 18th, Charlotte, NC

Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - May 6th - 9th, San Antonio, TX

Ideal for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy offers practitioners a deeper understanding of effective compliance management in a healthcare setting. The...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Privacy Compliance Academy - October 16th - 19th, San Francisco, CA

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Privacy Compliance Academy is ideal for practitioners who want a deeper understanding of effective compliance management in a...more

Health Care Compliance Association (HCCA)

[Virtual Event] Columbus & Indianapolis Regional Healthcare Compliance Conference - June 2nd, 8:25 am - 4:30 pm ET

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

Harris Beach Murtha PLLC

There’s an app for that! But is your health care app in compliance?

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 Compliance Association (HCCA)

[Virtual Event] San Francisco Regional Healthcare Compliance Conference - December 2nd, 8:25 am - 4:30 pm PST

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

Orrick, Herrington & Sutcliffe LLP

Year-End Roundup for Health Data Privacy: What Life Sciences and Healthcare Companies Need to Know for 2022

We expect many of the trends of 2021 in health data privacy to continue to pick up steam this year. See below for six noteworthy trends that life sciences and healthcare companies should continue to keep an eye on in 2022: ...more

Mintz - Health Care Viewpoints

Information Blocking Rule: Key Considerations for 2022

While the Office of the National Coordinator for Health Information Technology (ONC) issued the 21st Century Cures Act; Interoperability, Information Blocking, and the ONC Health IT Certification Program (Information Blocking...more

Health Care Compliance Association (HCCA)

[Virtual Event] Hawaii Regional Healthcare Compliance Conference - October 7th, 7:55 am - 4:00 pm HST

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

Health Care Compliance Association (HCCA)

Still Missing a New Leader, Former OCR Directors, Experts Offer Advice, Task List

Issue a final rule revising the privacy regulation and write guidance on the information blocking rule. Formalize the fledgling audit program required by Congress more than 10 years ago. Engage with providers and other...more

Health Care Compliance Association (HCCA)

[Event] Boston Regional Healthcare Compliance Conference - September 10th, Newton, MA

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

Jackson Lewis P.C.

Information Blocking And HIPAA’s Right To Access – Is Your Practice Compliant?

Jackson Lewis P.C. on

Patient record requests can be a significant administrative burden for health care providers. An OCR enforcement initiative and a new federal law give providers more reason to get this process right. Since the Health...more

Jackson Lewis P.C.

Information Blocking And HIPAA’s Right To Access: Compliance Burdens For Healthcare Providers

Jackson Lewis P.C. on

Since the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule became effective in 2003, it generally required covered entities to provide patients timely access to their medical records. Of...more

Chambliss, Bahner & Stophel, P.C.

Developing Law and Enforcement Trends on Patient Data Access Create New Risks for Radiology Providers

Recent regulatory and enforcement developments in the area of access to patient information create significant new risks for radiology providers. In particular, imaging providers should pay close attention to these...more

Dentons

Information Blocking: Compliance Regulations Pushed Back to Spring 2021

Dentons on

Recognizing the difficulty of managing interoperable technology as well as the pressures from the global pandemic, the Department of Health and Human Services (HHS) announced a delayed implementation of the Cures Act, Section...more

Fox Rothschild LLP

Re-Setting The Clock For Responding To Individual Access Requests Under The Information Blocking Rule

Fox Rothschild LLP on

Covered entities beware: a timing pitfall lurks within the recently adopted rules prohibiting information blocking. We have posted about OCR’s “Right to Access Initiative” and numerous enforcement actions taken to make sure...more

Chambliss, Bahner & Stophel, P.C.

Be Aware of Recent Legal Developments Concerning Right of Access to Patient Information

Two major recent regulatory developments highlight the need for health care organizations to focus on compliance concerning requests for access to patient health information. HIPAA Right of Access Initiative As most...more

Fox Rothschild LLP

New OCR Resource Adds Guidance On HIPAA And Direct-To-Consumer Health Apps

Fox Rothschild LLP on

A tricky issue for mobile health app developers since the Office for Civil Rights (OCR) released its first “Health App Use Scenarios & HIPAA” guidance back in 2016 has been deciphering whether the developer is a business...more

Sheppard Mullin Richter & Hampton LLP

Information Blocking And The Right To Access Initiative: Why Patients Struggle to Obtain their Medical Records and what the Office...

Access to healthcare information (or lack thereof) has always been touted as one of the key factors/necessities to realizing the promise of technology in the delivery of healthcare. Despite various legislative, judicial,...more

McDermott Will & Emery

2018 Digital Health Data Developments – Navigating Change in 2019

Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more

K&L Gates LLP

OCR Clarifies Confusion Related to Authorizations for Ongoing and Future Research Purposes

K&L Gates LLP on

As mandated by the 21st Century Cures Act of 2016 (the “Cures Act”), in June 2018 the Office for Civil Rights (“OCR”) issued guidance clarifying how individual authorizations under the Privacy Rule of the Health Insurance...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

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