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Senior Living Alert: HIPAA Security Rule Compliance for Senior Living Facilities

The U.S. Cybersecurity & Infrastructure Security Agency has deemed healthcare entities “target rich, cyber poor,” meaning they have copious amounts of consumer and patient data but often do not have the cybersecurity means to...more

Ounce of Prevention: Are You Keeping Track of Your Business Associate Agreements’ Requirements?

Applicable Provider Types: All - Is Your Entity in Compliance? The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009...more

Ounce of Prevention: Do Your Business Associate Agreements Have All Required Provisions?

Applicable Provider Types: All - Is Your Entity in Compliance? The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of...more

Ounce of Prevention: Do You Have Business Associate Agreements With Every Required Party?

Applicable Provider Types: All - Is Your Entity in Compliance? The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009...more

FAQs: An Essential Guide for Healthcare Leaders Navigating FTC’s Non-Compete Ban

The Federal Trade Commission’s April 23 final rule banning most non-competes for workers in the United States, including clinical and non-clinical employees in the healthcare industry, undoubtedly will raise questions from...more

Ounce of Prevention: Is It Time to Perform a Security Risk Assessment?

Applicable Provider Types: All - Is Your Entity in Compliance? The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of...more

OIG Plans New Guidance for Medicare Advantage and Nursing Homes

In its General Compliance Program Guidance (GCPG) issued in November 2023, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) announced its intent to publish industry segment-specific...more

OCR Continues Holding Healthcare Entities Accountable for Protected Health Information Breaches

On Feb. 6, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced a $4.75 million settlement with New York nonprofit health system Montefiore Medical Center over alleged malicious...more

FDA Publishes Two Key Guidance Documents on Cosmetics Facility Registration and Product Listing

The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....more

OIG’s New Compliance Guidance: 10 Action Items and Six Themes for Providers

On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued the General Compliance Program Guidance (GCPG) for healthcare providers and other industry stakeholders. The GCPG...more

Office for Civil Rights Settlement May Signal Increasing Scrutiny for Ransomware Attacks

On Oct. 31, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced it had settled with Doctors’ Management Services Inc. (DMS) over a self-reported ransomware attack that occurred in...more

Homeland Security and HHS Release Interactive Healthcare Cybersecurity Toolkit

On Oct. 25, 2023, in light of a “significant rise in the number and severity of cyber-attacks against hospitals and health systems in the last few years,” the U.S. Department of Homeland Security Cybersecurity and...more

FDA Publishes New Guidance on Cybersecurity in Medical Devices

In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more

Mobile App Company Resolves DOJ and FTC Allegations of Health Breach Notification Rule and FTC Act Privacy Violations

On June 23, 2023, the Department of Justice (DOJ) and Federal Trade Commission (FTC) announced a stipulated resolution with Easy Healthcare Corporation to address allegations that Easy Healthcare violated Section 5 of the FTC...more

Subsector Snapshots — Why Investor Interest Is Ballooning in Cardiology

The growing cardiology subsector is one of the most sought-after and competitive specialties for healthcare investors. Stemming from an aging population and growing obesity demographic trends, demand for cardiovascular...more

End of COVID-19 Emergency: Legal Implications for Healthcare Providers

On Jan. 30, 2023, President Joe Biden announced that the COVID-19 public health emergency (PHE) will end May 11, 2023. Under the PHE, the federal government implemented a range of modifications and waivers impacting Medicare,...more

OIG to Expand Informal Guidance with New FAQs

The Office of Inspector General (OIG) has announced that it is expanding the topics it considers for new Frequently Asked Questions (FAQs) submitted by healthcare stakeholders. OIG will now answer general questions about the...more

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