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No Harm, No Foul – Appellate Court Finds No CMIA Claim Without Actual Injury

California’s Confidentiality of Medical Information Act, Cal. Civ. Code § 56 et seq. (“CMIA”), provides that an individual may recover $1,000 nominal damages (plus actual damages if any) based on the negligent release of...more

Los Angeles County Sues Hospital Owner for False Surgical Implant Claims to County Workers’ Compensation Program

On July 18, 2014, the County of Los Angeles (“the County”) filed a lawsuit in Los Angeles Superior Court again Michael D. Drobot, Sr., his son Michael R. Drobot, Jr. and their controlled entities, Pacific Hospital of Long...more

OIG Issues Special Fraud Alert on Laboratory Payments to Referring Physicians

The Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services recently issued a Special Fraud Alert (“Alert”) that addresses two types of arrangements that the OIG believes pose a substantial...more

WEBINAR: Preparing for the HITECH September Deadline - Tips for Negotiating Effective Business Associate Agreements under HIPAA

Business Associate Agreements (BAAs), in the current regulatory and technological environment, require careful review and negotiation of the implementation of the regulatory requirements. In meeting the September 23, 2014...more

FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

Telemedicine: Many Opportunities, Many Legal Issues, Many Risks

Telemedicine touches on multiple practice areas for health care lawyers, such as payment and reimbursement, fraud and abuse, credentialing and privileging, peer review, privacy, consent, licensing, and regulatory compliance....more

Recent OCR Reports Illustrate Past and Future Compliance and Enforcement Efforts

Daily news stories about data breaches and enforcement actions seem to be the new norm, so it’s no surprise that people may start to believe that hackers have won the war and that no personal health information is safe. But...more

California Court of Appeal Rules Damages Are Unavailable To Plaintiff Patients Where Patient Information On Stolen Computer Was...

Until last week, Sutter Health was looking at a potential jury verdict in excess of $4 billion against several of its affiliated hospitals in a class action suit filed under the California Medical Information Act, California...more

OCR to Begin Phase 2 of HIPAA Audit Program

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) will soon begin a second phase of audits (Phase 2 Audits) of compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA)...more

HHS Issues Interpretive Rule Excluding Orphan Drugs from 340B Program Discounts Only for Designated Orphan Status Uses

On July 21, 2014, the Health Resources and Services Administration of HHS (HRSA) issued an interpretive rule interpreting Section 340B(e) of the Public Health Service Act as excluding from the 340B Drug Pricing Program orphan...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - On Monday, July 28, the House Committee on Energy and Commerce, Subcommittee on Health will hold a markup to consider two bills: H.R. ____, a bill to require the Secretary of Health and Human...more

FDA Issues 510(k)/Substantial Equivalence Draft Guidance Describes Benefit-Risk Factors Considered for New 510(k) Devices with...

On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)]with Different...more

Appellate Court Rules Medical Information Must Actually Have Been Viewed by an Unauthorized Person for a Plaintiff to Recover...

The California Court of Appeal recently held that in order to recover under California’s Confidentiality of Medical Information Act (CMIA), Civ. Code §§ 56 et seq., a plaintiff must plead and prove that the “stolen medical...more

Florida Information Protection Act of 2014 - Florida Means Business When It Comes to Protecting Customers' Personal Information

On June 20, 2014, Governor Rick Scott signed into law the Florida Information Protection Act of 2014 ("FIPA"), which became effective July 1, 2014. FIPA expands the obligations of businesses and government entities that...more

California Court Dismisses Data Breach Class Action

Last week, the California Third District Court of Appeal dismissed what may have been the largest health data breach class action in history. Consistent with a trend of similar dismissals, the California state appellate court...more

It’s No Surprise: Health Care Data Breaches Are on the Rise and So Is Government Enforcement

In This Issue: - The Take-Aways for Covered Entities and Business Associates - For More Information - Excerpt from The Take-Aways for Covered Entities and Business Associates: As a majority of the...more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

Rhode Island Hospital Reaches Settlement with Massachusetts AG to Resolve Data Security Allegations

Last week, Women & Infants Hospital of Rhode Island (“W&I”) reached a settlement with the Massachusetts Attorney General to resolve allegations that W&I failed to adequately protect personal data stored on unencrypted backup...more

Lessons From Omnicare Settlement In 'Swapping' Cases

On June 25, the U.S. Department of Justice announced that it had settled with Omnicare Inc. in two matters alleging that kickbacks resulted from below-cost discounts offered to skilled nursing homes as an inducement to select...more

Health Alert (Australia) - July 28, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 22 July 2014 - Lane v Northern NSW Local Health District (No 3) [2014] NSWCA 233 - This...more

Under the Dome: Inside the Maine State House

In recent months, a federal political issue has developed regarding undocumented immigrants crossing into the United States. This week, it was revealed that this issue touches on Maine, when Governor LePage was notified by...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

Are your HIPAA ducks in a row? The next round of OCR HIPAA audits is approaching

In 2011 the Department of Health and Human Services’ Office for Civil Rights (OCR) established the HIPAA Pilot Audit Program to ensure compliance with HIPAA’s privacy, security and breach notification rules. The first...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

California Appellate Court Requires Actual Viewing of Confidential Information in Data Breach Case Under the California Medical...

In a case against Sutter Health involving records from a stolen office computer, the California Court of Appeal recently issued a decision limiting plaintiffs’ ability to state a claim and obtain statutory damages under the...more

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