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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On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials.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FDA Issues Draft Guidance on Medical Device Accessories

On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015)...more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

Survey Says Sharing Information is Crucial in a Volatile Data Security Environment

Information sharing allows for better insight into existing threats and vulnerabilities and alerts organizations to the existence of important data that can help prevent cyberattacks and mitigate the effects of ongoing...more

New Jersey Court Supports Peer Review Immunity for Hospital

On November 24, 2014, the New Jersey Appellate Division affirmed a lower court’s decision to dismiss a physician’s lawsuit against a hospital based on federal and state statutory immunity provisions that shield hospitals and...more

Final Menu Labeling Rules Released by FDA

The U.S. Food and Drug Administration (FDA) released two final rules for menu and vending machine labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive...more

Behavioral Managed Care Organizations Do Not Have Unbridled Discretion – Providers Have Rights

Here is a common scenario: A behavioral healthcare provider has committed substantial resources into developing specialized behavioral healthcare services in the counties managed by a Managed Care Organization (“MCO”) under...more

Focus on Regulatory Law - October 2014

In This Issue: - Regulatory Authorities - Energy - Public Economy Law - State Aid - Contract - Public Health - In Brief - Excerpt from Regulatory Authorities: French Competition...more

MoFo New York Tax Insights - Volume 5, Issue 9 - September 2014

In This Issue: - ALJ Upholds Denial of Sales Tax Refund Because Vendor Failed to First Make Refunds to Customers - HMO Held Exempt from New York City General Corporation Tax - State Tax Department Issues...more

Favorable Ruling: Taxability of HMOs Under New York City General Corporation Tax

A New York City Tax Appeals Tribunal Administrative Law Judge (ALJ) recently ruled in favor of Aetna, Inc. (Aetna) on whether a health maintenance organization (HMO) was “doing an insurance business” in New York State,...more

The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more

Health Care Reform Implementation Update - July 2014

Last week the Senate debated a bill to reverse the Supreme Court’s contraception mandate decision, a group of House Republicans introduced a bill to replace Affordable Care Act (ACA) cuts to the Medicare home health benefit...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

FDA Finalizes Guidance on "Mobile Medical Applications"

On September 25, 2013, the Food and Drug Administration (FDA) issued final guidance on Mobile Medical Applications – healthcare related software applications intended for use on mobile platforms such as smartphones and...more

Court Sides With CMS Stark Regulations on Physician-Owned Under Arrangement Service Providers

On May 24, the U.S. District Court for the District of Columbia in Council for Urological Interests v. Sebelius1 (‘‘CUI’’) sided with the Centers for Medicare & Medicaid Services in a lawsuit brought by a group of urologists...more

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