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Beyond Ebola: Environmental Regulatory Issues Creating Business Risks for Health Care Providers

Business and legal risks to health care companies reach far beyond scientific uncertainties in the prevention protocols for infectious diseases due to lack of clarity among regulators with public health...more

NLRB Affirms Its Previous Decision Requiring Employer to Continue Providing Annual Wage Increases Beyond Contract Expiration

We previously blogged about the NLRB’s relatively shocking September 2012 decision in Finley Hospital (359 NLRB No. 9), in which the Board held that an employer was required to continue providing wage increases after the...more

Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

OIG Issues Compliance Guidance for Healthcare Governing Boards

Members of healthcare governing boards now have direction from the OIG as to what is expected of them as they oversee the regulatory compliance of their organizations. And the good news is that the board members don’t have to...more

Compliance Guidelines for Governing Boards: Some Further Thoughts and Comments

On April 20, 2015, four organizations (including OIG, American Health Lawyers Association, the Association of Healthcare Internal Auditors and the Health Care Compliance Association) issued “Practical Guidance for Health Care...more

Spotlight on Responsibility and Accountability: OIG’s New Compliance Guidance for Health Care Governing Boards

On April 20, 2015, the Office of the Inspector General of the U.S. Department of Health and Human Resources (“OIG”), in collaboration with the American Health Lawyers Association, the Association of Healthcare Internal...more

OIG Issues Compliance Oversight Guidance for Governing Boards of Health Care Organizations

On April 20, 2015, the Office of Inspector General (OIG), in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association, and the Health Care Compliance Association, issued...more

OIG Issues Board Guidance on Compliance Oversight

On April 20, 2015, the Inspector General of the Department of Health and Human Services (OIG), the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA) and the Health Care...more

OIG Releases New Guidance Offering “Practical Tips” to Health Care Boards for Overseeing Compliance Program Functions

On April 20, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”), together with industry leaders, released a new educational resource to help governing boards of health care...more

OIG Provides Additional Compliance Guidance for Healthcare Governing Boards

On April 20, 2015, the HHS Office of Inspector General (HHS OIG), in collaboration with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA), and the Health Care Compliance...more

OIG Issues Practical Guidance for Health Care Governing Boards on Compliance Oversight

On April 20, 2015, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”), in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers...more

5 Takeaways from the HHS OIG’s Guidance for Health Care Governing Boards

Tuesday, the HHS OIG, in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association (AHLA), and the Health Care Compliance Association, released a guidance document entitled...more

Open Season on Provider-controlled Licensing Boards

In a closely followed decision with significant consequences for state licensing boards and their members, the Supreme Court in North Carolina State Board of Dental Examiners v. Federal Trade Commission, 135 S. Ct. 1101...more

Prosecutors Strike Gold in Retailers’ Dumpsters with Hazardous Waste Enforcement Action

Retailers should implement hazardous waste management plans, even for simple consumer goods, as California, New York and other states launch aggressive enforcement campaigns. In recent years, California prosecutors...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

Supreme Court Holds State Regulatory Board Not Immune From Antitrust Laws

On February 25, 2015, the U.S. Supreme Court determined that the North Carolina State Board of Dental Examiners (“Dental Board”) is not shielded from federal antitrust law under the doctrine of state-action antitrust...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Blog: Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

OIG Responds to Hospital Compliance Review Objections

The OIG has defended its hospital compliance review policies in response to objections raised by the American Hospital Association (AHA). Specifically, a January 15, 2015 OIG letter addresses four main areas of AHA concern...more

FDA Issues Draft Guidance on Medical Device Accessories

On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015)...more

Of Broken Leases and ‘Broken Windows’

On Dec. 3, 2014, the Division of Enforcement of the U.S. Securities and Exchange Commission brought an enforcement action against two former top executives of Assisted Living Concepts LLC, a large provider of senior living...more

To Close or Not to Close: Tennessee Attorney General Weighs in on Hospital Bonuses and What Constitutes a Strategic Plan

On January 28, 2015, the Tennessee Attorney General ("Attorney General") issued a formal opinion ("Opinion") addressing whether Tennessee law permits "the board of a public hospital to meet in closed session to discuss...more

Patterson Companies Lead the Charge to Secure Dental Supply Chain

On January 14, 2015, Patterson Companies, LLC, announced that it is formalizing its efforts to shore up its supply chain integrity for its dental customers. The program will assure that dental products that Patterson Dental...more

IT Maintenance Crucial for HIPAA Compliance

The Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) recently announced an agreement with a medical center to settle charges stemming from the center’s failure to prevent malware from infecting its...more

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