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Data Transmission, Personalized Medicine, and Privacy

Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of...more

Latest OCR Enforcement Action: Underbed Storage is Not Appropriate for PHI

Recent enforcement actions by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) have highlighted that, not surprisingly, Covered Entities should not leave medical records in a...more

Historic Moment: Husband Reports Wife’s HIPAA Violation Triggering Six Figure Penalty Against Employer

For the second time in history, the Office for Civil Rights (“OCR”) has imposed a civil monetary penalty (“CMP”) against a covered entity for violations of the Health Insurance and Portability Act (“HIPAA”). Lincare, Inc., a...more

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details...more

FDA Releases Draft Guidance for Medical Device Cybersecurity

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called...more

Centene announces search for missing hard drives containing PHI of 950,000 individuals

Centene Corporation, a health insurer headquartered in St. Louis, announced on January 25, in a press release that it is undertaking an, “ongoing comprehensive internal search for six hard drives that are unaccounted for in...more

Cybersecurity Act Of 2015 Aims To Bolster Cybersecurity In Health Care Industry

Section 405 of Title IV of the Cybersecurity Act is tailored specifically to cybersecurity matters affecting public and private health care entities. Section 405 of Title IV seeks to improve the cybersecurity landscape in...more

FDA Issues Draft Guidance Governing Postmarket Cybersecurity Risk Management Standards

On January 15, 2016, the U.S. Food and Drug Administration (FDA) announced in a Press Release that it would issue draft guidance on January 22 outlining “steps medical device manufacturers should take to continually address...more

FTC Enforcement in Schein: Misleading Statements about Encryption and Cybersecurity

On January 5, 2015, the Federal Trade Commission (FTC) entered into a consent order with dental software manufacturer Henry Schein Practice Solutions, Inc. ("Schein") in connection with allegations that Schein had made...more

When do healthcare defendants want to be accused of malpractice?

Most injury or wrongful death cases against hospitals, health care facilities, and health care practitioners are governed by the procedures in Fla. Stat. 766, also known as the Medical Malpractice Act. This Act itself is...more

“Interoperable” Healthcare Data Will Be a Tempting Target

At a panel during last week’s Consumer Electronics Show in Las Vegas, Edith Ramirez, chair of the Federal Trade Commission – America’s top privacy regulator – said she would not wear a Fitbit personal fitness tracker. “I...more

Initiative to Improve Quality After Discharge: New Caregivers’ Laws

This month Indiana, Illinois, California, Oregon, and New Hampshire join 11 other states with newly effective Care Advise Record Enable (CARE) laws requiring hospitals to give patients the opportunity to designate caregivers...more

Making it easier to get your own medical records

Getting a copy of your own medical records is supposed to be easy and inexpensive. It also can be essential for ensuring the best medical care. But many hospitals and doctors have made it difficult and pricey, and the federal...more

Lessons Learned from LabMD's Successful Challenge to the FTC's Cyber Authority and Wyndham's Monumental Settlement with the FTC

On the shifting sands of cyber security regulation, it is important to understand the outcome of two recent enforcement cases brought by the Federal Trade Commission (FTC) – one against clinical lab services company LabMD,...more

FTC settles with software provider over misleading customers about encryption of patient data

The Federal Trade Commission (FTC) announced on January 5, 2016, that it has agreed to settle an investigation with Henry Schein Practice Solutions, Inc. (Schein), an office management software provider for dental practices...more

As if a 20-Year Consent Order Wasn’t Enough Fun: FTC Brings First Monetary Settlement in Information Security Case

The FTC reached a $250,000 settlement with a 20-year consent order with Henry Schein Practice Solutions, Inc. over its use of allegedly subpar encryption technology in its offering to dental practices. This settlement is...more

FTC files brief in LabMD appeal

We previously reported that the Federal Trade Commission (FTC) lost its case against LabMD alleging that LabMD had inadequate security measures to prevent an alleged data breach....more

ProPublica releases HIPAA Helper

A damning series of reports by ProPublica has revealed that based upon its analysis of federal data, “hundreds of health providers nationwide” have repeatedly violated HIPAA between 2011 and 2014. According to the...more

Update on Excellus data breach litigation

Excellus Blue Cross Blue Shield (Excellus) was hit with another proposed class action suit late last week. The case, filed by a New York woman, accuses Excellus BlueCross BlueShield of failing to prevent a massive data...more

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

Webinar PowerPoint Slides: Medical Apps and Devices: The Convergence of FDA, FTC, and State and Federal Regulations

These are the PowerPoint slides from this webinar: Years ago, if someone told you that computers would replace doctors for medical treatment, you would have laughed. While we have yet to reach this paradigm, mobile medical...more

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