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Omnibus funding bill creates healthcare cybersecurity task force

The $1.1 trillion spending and tax extender bill that is on President Obama’s desk awaiting signature creates a healthcare industry cybersecurity task force, which must be established within 90 days of enactment. This is...more

The University Of Washington Medicine Agrees To Settlement For Potential HIPAA Violations

The University of Washington Medicine (“UWM”) has agreed to settle the investigation conducted by the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) of potential HIPAA violations arising from a...more

Cyber Attack Information Sharing will Bring Liability Protections to Companies

On December 18, 2015, President Obama signed the 2016 Consolidated Appropriations Act. Included in this must-pass federal funding legislation is the Cybersecurity Act of 2015, which represents the most significant federal...more

University of Washington Medical School pays OCR $750,000 for data breach

The Office for Civil Rights (OCR) announced on Monday, December 14, 2014, that it has settled a HIPAA investigation with the University of Washington Medical School involving a data breach in October of 2013....more

Blog: University of Washington Medicine Agrees to Settle Alleged HIPAA Breach

Last week, the University of Washington Medicine (UWM), an affiliated covered entity that includes multiple entities such as the University of Washington Medical Center, agreed to settle alleged violations of the Health...more

University with Multiple Covered Entity Components Enters Into $750,000 HIPAA Settlement

On December 14, 2015, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced a $750,000 settlement with the University of Washington (UW). This is the third HIPAA settlement announced by OCR...more

MaineGeneral Health suffers cyber-attack

MaineGeneral Health (MaineGeneral), located in Augusta, Maine notified employees and patients last week that personal information and protected health information was compromised in a cyber-attack last month. The health care...more

U.S. must crack down on small but hugely painful patient privacy breaches

Although Americans may live in dread about large-scale data breaches by big corporations, instances in which health care personnel inappropriately peek and tell information from patients’ private medical records can be...more

FDA Plans Workshop to Address Cybersecurity in Medical Devices

Two months after finalizing its first guidance on cybersecurity, the FDA has announced a public workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” to continue to address a growing...more

Laptop Security Breach Leads to $850,000 HIPAA Settlement Payout

On November 19, 2015, Lahey Hospital and Medical Center (“Lahey”) entered into an $850,000 settlement with the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) for alleged violations of...more

FDA Legal and Regulatory – 2015 Year In Review

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on...more

Are Wearable Devices a Privacy Nightmare?

Wearable devices, such as fitness trackers and smart watches, have taken the United States technology industry by storm. In the past three years, there has been a 500% increase in the number of fitness bands and activity...more

NACDS Files Amicus Brief in Support of Petitioner Rite Aid in Consolidated Appeal of FCC’s TCPA Order

On December 2nd, the National Association of Chain Drug Stores, Inc. (“NACDS”) submitted an amicus brief in support of member organization and petitioner Rite Aid in the consolidated appeal of the FCC’s July 10, 2015...more

HIPAA and Health Care Data Privacy – 2015 Year in Review

As the year winds down, we look back with a mixture of nostalgia and queasiness on the major Health Insurance Portability and Accountability Act (HIPAA) events that defined 2015. Incredibly large data breaches became...more

One Step Closer to the Network and Information Security Directive

On Monday, the European Parliament, Council and Commission came to an agreement on the Network and Information Security (NIS) Directive. The NIS Directive is the first pan-European set of cyber security rules and aims...more

The Silent Threats of Breaches to Medical Devices are Starting to Make Noise

The U.S. Food and Drug Administration (FDA), which is responsible for guidance on medical devices, has acknowledged that certain devices are susceptible to breaches. The FDA has identified cybersecurity vulnerabilities in...more

Blog: University of Rochester Medical Center Reaches Agreement to Settle Alleged HIPAA Breach

Last week, the University of Rochester Medical Center (URMC) reached agreement with the New York Office of the Attorney General (NYOAG) to settle alleged violations of the Health Insurance Portability and Accountability Act...more

Stolen, Unencrypted Laptop Leads to $850,000 Settlement and Comprehensive Corrective Action Plan for Massachusetts Teaching...

The U.S. Department of Health and Human Services, Office of Civil Rights (OCR), has announced a settlement with Lahey Hospital and Medical Center (Lahey) that arose out of a HIPAA breach involving a stolen laptop. The...more

Triple-S settles HIPAA violations for $3.5M

Triple-S Management Corp., an insurance holding company based in San Juan, Puerto Rico, has agreed to settle an investigation of HIPAA violations by the Office for Civil Rights (OCR) for $3.5 million. According to the OCR...more

Hospice EndNotes - December 2015

Winds of Change Blowing Across the Hospice Landscape - Recent Medicare developments indicate that end-of-life health care providers can expect to face continuing change in an already dynamic sector. These latest turns...more

Lahey Hospital agrees to pay a whopping $850,000 to OCR for stolen laptop

Just before Thanksgiving, the Office for Civil Rights (OCR) announced that Lahey Hospital and Medical Center (Lahey) has agreed to pay $850,000 in fines and penalties to the OCR and enter into a resolution agreement following...more

Confusion Continues Over Medical Identity Theft Victim Rights under HIPAA

In a Nov. 10, 2015 letter, the Chairs and Ranking Members of the Senate Committee on Health, Education, Labor, and Pensions and the Committee on Finance raised concerns with the U.S. Department of Health and Human Services...more

FDA Regulatory and Compliance Monthly Recap — November 2015

Bill that refines marketing exclusivity for DEA scheduled drugs becomes law - The Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639) was passed in the House of Representatives and was sent to...more

Medical Devices And Risks Of Unauthorized Disclosure Of Protected Health Information

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) kicked off the holiday season by publishing a settlement agreement under the Health Insurance Portability and Accountability Act of 1996 (HIPAA)...more

Enbrel Biosimilar in Europe and US

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

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