News & Analysis as of

Risk Mitigation Health Care Providers Department of Health and Human Services (HHS)

Manatt, Phelps & Phillips, LLP

[Webinar] Preparing for the Future of Health Care Antitrust Scrutiny - June 11th, 12:00 pm - 1:00 pm PST

Now, more than ever, health care organizations are facing complex antitrust issues as their mergers/acquisitions, hiring, contracting and private funding are being scrutinized by the federal and state governments. Proper...more

Foley & Lardner LLP

Health-Related Social Needs: Three Trends in Leveraging Community Partnerships

Foley & Lardner LLP on

Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - March 1st, St. Louis, MO

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

BakerHostetler

HHS Publishes ‘Voluntary’ Healthcare Cybersecurity Performance Goals in Record Time but Leaves Questions Unanswered

BakerHostetler on

As previously reported in this blog, on Dec. 6, 2023, the Department of Health and Human Services (HHS or the Department) released a “concept paper,” which laid out its vision of future action regarding healthcare...more

Health Care Compliance Association (HCCA)

‘An Unknown Individual Walked In’: Protecting Against Telehealth Risks Includes Non-IT Threats

The HHS Office for Civil Rights (OCR) and other government agencies aren’t just worried that providers understand—and mitigate—the privacy and security risks of telehealth. In fact, in 2022, the Government Accountability...more

Ankura

OCR Issues Guidance to Patients and Providers on Telehealth Privacy and Security

Ankura on

On October 18, 2023, the Department of Health and Human Services (DHHS) through the Office for Civil Rights (OCR) issued an update1 containing two resource documents to help educate patients regarding privacy and security...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

McDermott Will & Emery

[Webinar] How Not to Lose $1M: Preparing for HHS-OIG Info Blocking Enforcement - August 15th, 1:00 pm - 2:00 pm EDT

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

Parker Poe Adams & Bernstein LLP

How North Carolina Hospitals Can Navigate the Thorny Legal Landscape Involving Emergency Abortion Care

​​​​​​​In recent months, decisions and laws limiting abortion rights in the United States have forced health care providers that serve pregnant women to keep abreast of quickly changing legal restrictions affecting their...more

Health Care Compliance Association (HCCA)

Telehealth regulatory oversight and enforcement trends

CT magazine (July 2022) - One of the notable impacts of the COVID-19 pandemic on the healthcare industry has been the boom in services provided via telehealth. This boom is in part due to temporary flexibilities applied...more

Goodwin

Federal Audits and Enforcement Actions of Telehealth Providers: Future Trends and Mitigating Risk

Goodwin on

As the COVID-19 pandemic progresses and the expanded use of telehealth has appeared to stabilize over the past year according to a July report from McKinsey & Company, Federal agencies have continued the recent trend of...more

Dorsey & Whitney LLP

OIG Advisory Opinion No. 21-02 Provides Helpful Insights into Risk Mitigation Factors Regarding Health System-, Physician-, and...

Dorsey & Whitney LLP on

On April 26, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) issued favorable Advisory Opinion No. 21-02 regarding a proposed investment in an ambulatory surgery center (“ASC”) by a...more

Health Care Compliance Association (HCCA)

Stephen Shaver on CARES Act Relief Funds and Healthcare Organizations

While the CARES Act provided much needed funding, it wasn’t a handout for healthcare providers. There are strings attached, explains Stephen Shaver, an attorney with Wachler & Associates and author of the Chapter “Revenue...more

McDermott Will & Emery

[Webinar] Regulatory Disputes with HHS: When to Negotiate and When to Litigate - March 25th, 12:00 pm - 1:00 pm EST

McDermott Will & Emery on

For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient...more

Alston & Bird

Telehealth Turbulence: Explosive Expansion Coincides with Emerging Enforcement Priorities

Alston & Bird on

Loosening regulations on telehealth during the coronavirus pandemic has, unsurprisingly, led to a boom in telehealth use. At the same time, telehealth has emerged as a key enforcement initiative of the Department of Justice...more

K&L Gates LLP

Qui Tam Quarterly - Uncertain Relief: Navigating Cares Act Provider Relief Fund Guidance and False Claims Act Risks

K&L Gates LLP on

This edition of the Qui Tam Quarterly focuses on the potential False Claims Act (FCA) risk areas faced by health care provider recipients of payments from the Provider Relief Fund (PRF) created by the CARES Act, as well as...more

Baker Donelson

FBI Warns Hospital and Health Care Providers are Under Attack

Baker Donelson on

A public cybersecurity advisory was issued yesterday about a likely ransomware attack against the health care and public health sector. The Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of...more

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

Baker Donelson

New HHS Guidance on Solid Organ Transplantation: Reducing Risk and Increasing Availability

Baker Donelson on

Organ procurement organizations (OPOs) and transplant centers should take note: as expected, and as outlined in our recent organ procurement and transplant alert, the U.S. Department of Health and Human Services (HHS)...more

Health Care Compliance Association (HCCA)

With Its Vague Terms, Relief Fund Has Compliance Risks; 'Look from Several Angles'

Report on Medicare Compliance 29, no. 16 (April 27, 2020) - Because of the coronavirus, the talents of a business development executive at a hospital are wasted, and the chief financial officer (CFO) is wondering whether...more

Shumaker, Loop & Kendrick, LLP

Client Alert: The Lack of an Adequate HIPAA Security Risk Assessment is a Common and Costly Mistake by Healthcare Providers: What...

Health care providers and others who must comply with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) have specific requirements under the Security Rule to HIPAA when it comes to their mainte-nance...more

Steptoe & Johnson PLLC

Some HIPAA Happenings

Proposed Modifications to HIPAA Regulations under Consideration - On December 14, 2018, HHS issued its Request for Information on Modifying HIPAA Rules to Improve Coordinated Care as part of its Regulatory Sprint to...more

Foley & Lardner LLP

DHHS Releases Guidance on Managing Cybersecurity Threats in the Health Care Sector

Foley & Lardner LLP on

The U.S. Department of Health and Human Services (DHHS) recently released Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients (HICP). DHHS states that the purpose of the HICP is to: 1. Raise...more

Womble Bond Dickinson

Healthcare Industry Reminded to Heed Cybersecurity: New “Industry Standard” Guidance

Womble Bond Dickinson on

The Department of Health and Human Services (HHS) observes that the US healthcare system lost $6.2 billion dollars as a result of data breaches in 2016 and that 4 out of 5 US physicians have experienced some form of...more

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