Consumer Protection Science, Computers & Technology Health

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Guest Post - Just the Fax, Ma’am

While Bexis is on vacation, here is a guest post to take up some of the slack. Our guest blogger today is Henry Pietrkowski, a partner in Reed Smith's Chicago office. This one's a little different. It's about the impace of...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Class Action Suit Filed Against UCLA After It Suffers Massive Data Breach Affecting 4.5 Million Individuals

In yet another data breach affecting millions of individuals, UCLA Health System (“UCLA”) reported on July 17, 2015, that hackers had accessed portions of its health network that contained personal information, including...more

Cybersecurity is once again a hot topic as Illinois undergoes PIPA update

Cybersecurity is a hot topic at both the state and federal level. Specifically, Illinois is in the process of amending its Personal Information Protection Act (“PIPA”). Illinois SB 1833 will amend PIPA by establishing more...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

Hospital’s Cloud-Based Document-Sharing Practices Lead to $218,400 HIPAA Settlement

On July 10, 2015, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced a substantial settlement with St. Elizabeth’s Medical Center (SEMC). Under the terms of the settlement, the hospital...more

OCR Settlement with Massachusetts Hospital Over HIPAA Violations

On July 8, 2015, the United States Department of Health and Human Services, Office for Civil Rights (“OCR”), which enforces federal privacy standards for protected health information (“PHI”), settled an enforcement action...more

UCLA Health System announces data breach affecting 4.5 million patients and medical providers

Adding to the long list of cyber hacking victims, the UCLA Health System announced on Friday (July 17, 2015) that it confirmed on May 5, 2015 that a cyber-attacker had accessed parts of UCLA Health’s network back to September...more

Rhode Island Governor Signs Comprehensive Identity Theft Protection Act

On June 26, Rhode Island Governor Gina Raimondo (D) signed into law Senate Bill 0134, the Rhode Island Identity Theft Protection Act of 2015 (the Act), which clarifies data security measures, expands protection to health data...more

HIPAA Settlement Regarding Use of Internet Applications

On July 10, 2015, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced a settlement agreement with St. Elizabeth's Medical Center (SEMC) in Brighton, Massachusetts, regarding potential...more

Hospital Pays $218,400 to OCR for HIPAA Violations

St. Elizabeth’s Medical Center (“SEMC”), a tertiary care hospital in Brighton, Massachusetts, has agreed to pay $218,400 to the Office for Civil Rights (“OCR”) to settle alleged violations of the Health Insurance Portability...more

Recent HHS Settlement Highlights Risks of Electronically-Sharing Protected Health Information

On July 10, 2015, the United States Department of Health and Human Services Office for Civil Rights (OCR) announced its second settlement of the year for violations of the Health Insurance Portability and Accountability Act...more

Use of File-Sharing Service Leads To $218,400 Fine For HIPAA Violations

Internet-based file-sharing services such as Dropbox and Google Drive can be easy and convenient to use, whether via the touch of an app on a mobile device or by opening a browser on a PC. Healthcare professionals are often...more

Connecticut Imposes New Data Security Obligations

New law will require consumer breach notice within 90 days, identity theft protection for consumers,“kill switch” for smartphones, and implementation of data security programs for certain health providers, state agencies and...more

FDA Regulatory and Compliance Monthly Recap – June 2015

In This Issue: - FDA draft guidance explains benefit-risk considerations for IDE applications - Allergan warned by FDA over unapproved marketing of SERI Surgical Scaffold - FDA provides guidance on...more

FAS Russia official recommendations on the commercial policies of manufacturers of pharmaceuticals and medical devices holding a...

On June 30, 2015 on its official site FAS Russia published recommendations for entities holding a dominant position on pharmaceuticals markets and medical devices markets (hereinafter together “pharmaceutical companies”) to...more

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

Oregon Expands Data Breach Law

The modified law will expand the definition of personal information to include medical information and physical characteristics, and require notification to the state Attorney General. Businesses with customers in Oregon...more

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

A New Era of HIPAA Enforcement

Traditionally, HIPAA enforcement is assigned to the Department of Health and Human Services’ Office for Civil Rights (OCR). In November 2013, Health and Human Services’ Office of Inspector General sharply criticized OCR’s...more

Upcoming HIPAA Audits May Target Financial Institutions—Here’s How to Prepare

Much like a tornado watch, the conditions appear to be right for a coming storm: the upcoming Phase 2 HIPAA audits. The Department of Health and Human Services Office for Civil Rights (OCR) has begun verifying contact...more

Connecticut Legislature Passes Bill Mandating Identity Theft Protection Services Following Data Breach

Connecticut’s legislature has passed a bill that imposes strict new timing requirements for entities conducting business in the state that experience a data breach, which Governor Malloy reportedly intends to sign into law. ...more

Advocate Health data breach class action suit dismissal upheld by Appellate Court

In August of 2013, four computers of Advocate Health and Hospitals Corporation (Advocate Health) were stolen from one of its offices. The computers contained the names, dates of birth, Social Security numbers, health...more

Medical Informatics Engineering discloses data breach

Electronic health record (EHR) vendor Medical Informatics Engineering and its subsidiary, NoMoreClipBoard, which is a personal health record (PHR) product, notified its EHR clients and PHR individuals that it has been the...more

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