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HHS Establishes Certification Requirements for Artificial Intelligence and Machine Learning Software Developers

As the impact of artificial intelligence on various sectors of the U.S. economy grew in 2023, so did the involvement of regulators and policymakers. One of the most recent — and substantive — regulatory standards is the...more

Supreme Court Gives the OK to CMS Vaccine Mandate

Yesterday, the U.S. Supreme Court issued its opinion by a 5-4 vote with Justices Clarence Thomas, Samuel Alito, Neil Gorsuch and Amy Coney Barrett dissenting regarding the Department of Health and Human Services Interim Final...more

HHS Office of Inspector General Issues Important Update to Self-Disclosure Protocol

For the first time since 2013, on November 8, 2021, the Health and Human Services Office of Inspector General (“HHS-OIG” or “OIG”) made a number of significant updates to its Health Care Fraud Self-Disclosure Protocol...more

CMS Announces Vaccine Mandate for Healthcare Facilities

On Thursday, November 4, 2021, contemporaneous with the announcement of the new Emergency Temporary Standard (“ETS”) of the Occupational Safety and Health Administration (“OSHA”) requiring COVID-19 vaccination or testing for...more

Federal Trade Commission Provides New Guidance on its Health Breach Notification Rule for Health Apps and Connected Devices

On September 15, the Federal Trade Commission (“FTC”) issued a policy statement (“Statement”) addressing the scope of its Health Breach Notification Rule (“Rule”) on health apps and connected devices. The Rule, first issued...more

Arizona Expands Telehealth Law, Making it Broadest in the Nation

On May 5, 2021, Governor Ducey signed H.B. 2454, legislation which dramatically expands access to telehealth services in Arizona. The legislation—the most expansive in the country—makes telemedicine a permanent fixture of...more

Governor Ducey Signs Executive Order 2021-09 Banning Use of Vaccine Passports in Arizona

On Monday April 19, 2021, Arizona Governor Doug Ducey signed Executive Order 2021-09 banning vaccine passports in Arizona—also known as digital health passports (“DHPs”). The Executive Order (“EO”) prevents local governments,...more

The Arizona Supreme Court Joins Other States in Ruling that HIPAA Can Be Used to Establish the Standard of Care in a Negligent...

On March 8, 2021, the Arizona Supreme Court held in Shepherd v. Costco1 that the plaintiff, Greg Shepherd, was permitted to bring a negligence claim for wrongful disclosure of medical information and that the Health Insurance...more

Telehealth Fraud Triggered by COVID-19 Pandemic

On January 14, 2021, the Department of Justice announced that it had obtained over $2.2 billion in settlements and judgments from fraud and False Claims Act cases over the previous fiscal year. More than 80 percent of False...more

McCarron-Ferguson Act Repeal Upends 75 Years of Exemptions for Health Insurers and Sets New Antitrust Enforcement Expectations

Since 1945, the McCarran-Ferguson Act (Act) provided insurance companies a limited exemption from federal antitrust laws, exempting certain state-regulated activities that qualified as the “business of insurance." The Act...more

Arizona Enacts “Surprise Out-Of-Network” Balance Billing Law

Arizona has joined the national trend of trying to solve the “problem” of “surprise medical out-of-network bills.” The prevalence of this concern was reported in the New England Journal of Medicine which stated that 22% of...more

Does Defensive Medicine Impact the Cost of Healthcare?

Healthcare in the United States costs at least two to three times as much as healthcare in other developed countries. One of the reasons usually given is defensive medicine – doctors who order unnecessary tests and procedures...more

Navigating the California Corporate Practice of Medicine “CPM” Prohibition

CPM is a variation of the statutory prohibition against unlicensed practice of medicine. CPM states enforce the prohibition against corporations practicing medicine by requiring a separation between medical/clinical decisions...more

Ninth Circuit Upholds Felony Conviction of Urologist, Under FDCA, for Reusing Single-Use Needle Guides During Prostate Biopsies...

In 2014, Las Vegas urologist, Dr. Michael Kaplan, was convicted by a federal jury for reusing single-use plastic needle guides during prostate biopsies. He was convicted of conspiracy to commit adulteration in violation of...more

The Physician’s Self-Referral Law – Are Changes Finally Coming?

The Physician Self-Referral Law, also known as the Stark law, prohibits a physician from referring federal health care program patients for “designated health services” to an entity in which the physician (or an immediate...more

Arizona Supreme Court Confirms Abolishment of Original Tortfeasor Rule

For more than thirty years, Arizona law has allowed juries to allocate fault among all who contribute to an injury. On July 18, 2016, the Arizona Supreme Court unanimously re-affirmed Arizona’s commitment to “comparative...more

HIPAA Violation — Pharmacy Held Liable for Employee’s Misdeeds

Recently, the Indiana Court of Appeals let stand a $1.4 million jury verdict against a national pharmacy chain for its employee pharmacist’s unauthorized disclosure of a customer’s confidential medical records.  Given the...more

Treating chronic pain can be risky for physicians

Opioids are the mostprescribed class of prescription medications in the United States. Physicians are the legal gatekeepers for prescription medications to treat chronic pain. Over the last 10 years, prescriptions for opioid...more

Can Accountable Care Organizations Hit the Trifecta: Improve Quality, Reduce Cost, and Increase Physician Compensation?

The New York Times recently reported that it found that the amount paid by a patient’s insurance plan for a routine colonoscopy varies significantly: between $740 and $8,500, depending upon the location, the particular...more

11/27/2013

Health Care Reform Expands Physicians’ Liability

The Patient Protection and the Affordable Health Care Act (“ACA”) is designed to reduce the cost of health care and to improve quality of care. To achieve these goals, the ACA relies, in part, on Accountable Care...more

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