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Patients Regulatory Requirements Health Care Providers

Health Care Compliance Association (HCCA)

OCR Loses Staff, Faces Move to New ‘Enforcement’ Office; Will HIPAA Focus, Independence Suffer?

Today, the HHS Office for Civil Rights (OCR) stands shoulder-to-shoulder with the likes of the Office of Inspector General and Office of General Counsel, one of just a dozen or so agencies reporting directly to the secretary....more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2024

Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more

Health Care Compliance Association (HCCA)

2nd Settlement Triggered by 2017 Ransomware Attack Costs WA Practice $100K; ‘Not a Breach’

Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more

Troutman Pepper Locke

Finding the Balance: Complying with Consumer Finance Legal Obligations When Offering Patient Payment Plans

Troutman Pepper Locke on

Health care providers often find themselves in the position of collecting direct payments for medical services through patient payment plans. While providers must adhere to a myriad of health care laws when doing so, they...more

Health Care Compliance Association (HCCA)

‘I Will Not Rest’; ‘I Am All In’: Remarkable Breach Hearing Sees Pledges by UHG CEO, Sen. Wyden

United Healthcare Group (UHG) CEO Andrew Witty was in a board meeting on Feb. 21 when officials interrupted with the news that Change Healthcare—a clearinghouse UHG subsidiary Optum had purchased for $1.3 billion in October...more

Smart & Biggar

PMPRB publishes scoping paper for consultation on guidelines, and invites stakeholder feedback

Smart & Biggar on

As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more

Nelson Mullins Riley & Scarborough LLP

Price Transparency – CMS Updates Enforcement Process

As many are aware, compliance with price transparency requirements continues to lag. Under the final rule, effective January 1, 2021, hospitals are required to provide clear, accessible pricing information online about the...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Virtual Regional Healthcare Compliance Conference - Richmond, VA - December 11th, 8:25 am - 5:30 pm EST

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

Bricker Graydon LLP

CMS announces reduced psychiatric hospital burden with new survey process

Bricker Graydon LLP on

On January 13, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a new streamlined survey and certification process for psychiatric hospitals as part of the agency’s “Patients over Paperwork” initiative. ...more

Nossaman LLP

California Health Care Entities Required to Report Patient Allegations of Sexual Abuse or Misconduct

Nossaman LLP on

As of January 1, 2020, when a patient (or their representative) submits a written allegation of sexual abuse or sexual misconduct to a health care entity, that entity must report the allegation to the appropriate state...more

Mintz - Health Care Viewpoints

FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

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

Akin Gump Strauss Hauer & Feld LLP

New Draft Policy on Clinical Decision Support Software Highlights FDA’s Release of Six New Digital Health Guidance Documents

• 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

Robinson+Cole Health Law Diagnosis

CMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers

The Centers for Medicare and Medicaid Services (CMS) is moving forward with its Patients over Paperwork initiative, which was created in accordance with President Trump’s Executive Order directing federal agencies to reduce...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Series of Guidance Documents Aimed at Medical Software Regulation

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

Robinson+Cole Health Law Diagnosis

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to...

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more

Polsinelli

California’s Patients Right to Know Act of 2018: What Providers Need to Know

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Effective July 1, 2019, The Patients Right to Know Act of 2018 (SB 1448) will require both Doctors of Medicine  (“M.D.s”) and Doctors of Osteopathic Medicine (“D.O.s”) to provide notice to all patients prior to their...more

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