Consumer Protection Science, Computers & Technology Health

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Hospital Text Messaging Rules Placed on Hold by Joint Commission

The Joint Commission, which accredits hospitals and other health care organizations, hit pause on its prior May 2016 announcement to allow secure text messaging in hospitals and other health care organizations. The use of...more

2.7 Million Dollar HIPAA Settlement

Last week, Oregon Health & Science University (“OHSU”) agreed to pay $2.7 million to resolve potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule, Privacy Rule, and...more

Breaking News: FTC Vacates ALJ’s Ruling and Finds LabMD Liable for Unfair Data Security Practices

In a ruling issued this morning, the Federal Trade Commission found that LabMD, the defunct Atlanta-based cancer detection lab, failed to protect patient information and is liable for unfair data security practices. The...more

Boosts in Ransomware Attacks Spark Multiple Government Agency Responses

Following a recent U.S. government interagency report indicating that, on average, there has been an alarming 300 percent spike in daily ransomware attacks since early 2016 as compared with 2015, the U.S. Department of Health...more

HHS OCR Guidance on Ransomware Attacks: They Constitute a “Security Incident” and Are Likely a Data Breach

On July 11, 2016, the HHS Office of Civil Rights (OCR) released guidance on HIPAA covered entities’ responsibilities in a ransomware attack, a type of cyber-attack that has targeted the health care sector extensively in...more

Is encryption the key to your data security?

With the increased rate of data breaches targeting personal information, an increased public awareness of online privacy, and an increasingly demanding regulatory landscape, large and small businesses are looking to...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

Breach of ePHI Results in $2.7 Million Fine

Oregon Health & Science University (“OHSU”) has paid $2.7 million to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) to settle allegations that it violated the Health Insurance Portability...more

Cybersecurity News & Notes – July 2016 #3

In Case You Missed It: Court certifies class in suit against Apple. On July 15, 2016, U.S. District Judge Jon S. Tigar certified a class of users of the mobile app Path, who allege that Apple facilitated the app’s access...more

Entity Fined $650,000 in First HIPAA Settlement with a Business Associate

The possibility of business associates potentially being audited, investigated, and ultimately fined is now a reality. On June 24, 2016, the United States Department of Health and Human Services’ Office of Civil Rights...more

“Your Money or Your PHI”: OCR Releases Guidance on Ransomware

On July 11, 2016, the Office for Civil Rights (OCR) released important new guidance on ransomware for hospitals and other healthcare providers and finally addressed the question of whether electronic protected health...more

FDA Regulatory and Compliance Monthly Recap – June 2016

FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions - The draft guidance will amend the FDA’s 20-year-old policy for categorizing devices...more

Business Associates Beware! OCR Is Coming For You

Last week, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced the first HIPAA settlement involving a business associate. Catholic Health Care Services of the Archdiocese of Philadelphia...more

Analysis of Health Care Data Breach Litigation Trends

Companies that have a breach involving protected health information ("PHI") worry not only about fines and penalties imposed by the Department of Health and Human Services ("HHS"), but about class action lawsuits. The risk...more

FDA Issues Final Rule on Use of Symbols in Labeling

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Business Associate Settles HIPAA Investigation for $650,000

The U.S. Office for Civil Rights (OCR), the agency responsible for enforcing the HIPAA Privacy and Security rules, has just sent a strong message that business associates are not immune from scrutiny. On June 24, 2016, in a...more

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

HIPAA Compliance: Navigating a Health Care Minefield

In the two decades since its original passage, complying with the federal Health Insurance Portability and Accountability Act (HIPAA) hasn’t gotten any easier. Enacted with the primary goal of protecting the confidentiality,...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

OCR Warns of HIPAA Risks in Third-Party Apps

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently issued a warning regarding vulnerabilities in third-party applications used by entities covered by HIPAA. The OCR warning applies...more

Practice Fusion and FTC Settle Complaint Over Deceptive Statements About the Privacy of Consumer-Generated Online Content

Last week, the Federal Trade Commission (FTC) announced (press release) that Practice Fusion, the largest cloud-based electronic health company in the United States, has agreed to settle FTC charges over deceptive practices...more

Cybersecurity News & Notes – June 2016 #3

In Case You Missed It: Illinois strengthened its data privacy and security law, with the amendments going into effect in January 2017. The amendments include expanding the definition of “personal information” to include a...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

PowerPoint Slides: Could My Company's Website Violate the Americans with Disabilities Act?

Under the Americans with Disabilities Act (ADA), places of public accommodation must ensure equal access to the goods and services they offer to disabled individuals. Is a company website subject to the ADA? The answer to...more

Wrap-Up of Federal and State Chemical Regulatory Developments, June 2016

TSCA/FIFRA/IRIS/NTP/TRI - TSCA Reform Bill Is Sent To President Obama For Signature: It has been reported that on June 14, 2016, House Speaker Paul Ryan (R-WI) and Senate President Pro Tempore Orrin Hatch (R-UT) signed...more

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