News & Analysis as of

Department of Health and Human Services (HHS) Health Insurance Portability and Accountability Act (HIPAA) 21st Century Cures Act

Holland & Knight LLP

HHS Is Primed to Enforce Information Blocking Conduct

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The U.S. Department of Health and Human Services (HHS) continued its commitment to timely and full access to health records on June 24, 2024, through the finalization of its information blocking disincentives rule for...more

Holland & Knight LLP

Reproductive Healthcare Privacy Rule Brings New Requirements for All Providers

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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

Lathrop GPM

OIG Publishes New Compliance Guidance for Health Care Entities, Along with Plan for Targeted “Industry Specific” Guidance Starting...

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On October 6, 2023, the Office of Inspector General at the U.S. Department of Health and Human Services (OIG) released brand new “General Compliance Program Guidance” to assist health care providers, entities, and other...more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

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

Holland & Knight LLP

Information Blocking Enforcement Penalties Begin Sept. 1, 2023

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The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently posted the final rule establishing civil monetary penalties (CMPs) for information blocking (IB Enforcement Rule). The Rule...more

BakerHostetler

Steep Penalties for Information Blocking Finalized

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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

Harris Beach PLLC

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

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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

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

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On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

Holland & Knight LLP

Medical Records Ownership and the Information Blocking Rules

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Patients may think they own their medical records. While patients certainly have the right to access and, in many cases, control how their health information is used and disclosed, medical records ownership can be murky....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

Jackson Lewis P.C.

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

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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

Husch Blackwell LLP

Information Blocking: College & University Student Health Centers – Does The Rule Apply To Us?

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Since last year, the Husch Blackwell privacy attorneys have been working with various healthcare providers—from hospitals to hospices, to independent physician groups—to comply with the Information Blocking rule (the Rule)...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

WilmerHale

Congress Passes Bill to Mitigate Penalties for Potential HIPAA Violations

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On December 19, the Senate passed H.R.7898, which the House of Representatives had previously passed on December 9. This law amends the Health Information Technology for Economic and Clinical Health (HITECH) Act to require...more

Hogan Lovells

HHS proposes changes to key provisions of the HIPAA Privacy Rule

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HIPAA Privacy Rule changes that have the potential to significantly impact patients, covered entities, and business associates were proposed by the Department of Health and Human Services (HHS) in a Notice of Proposed...more

Fox Rothschild LLP

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

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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

Holland & Hart - Health Law Blog

Healthcare Providers: Beware New Information Blocking Rule

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

Holland & Knight LLP

ONC, CMS Finalize Transforming Interoperability and Patient Access to Data Rules

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The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) on March 9, 2020, released separate but related final rules addressing interoperability,...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

Burns & Levinson LLP

HHS Releases Voluntary Cybersecurity Practices, Supplementing Existing Requirements

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At the close of 2018, the Department of Health and Human Services (HHS) published Health Industry Cybersecurity Practices (HICP): Managing Threats and Protecting Patients. While not formally styled as guidance or interpretive...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

Snell & Wilmer

2017 End of Year Plan Sponsor “To Do” List (Part 1) Health & Welfare

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As 2017 comes to an end, we are pleased to present our traditional End of Year Plan Sponsor “To Do” Lists. This year, we are presenting our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 will cover...more

Stinson LLP

21st Century Cures Act Includes Several Noteworthy Mental Health and Substance Use Provisions

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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

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