Science, Computers & Technology Consumer Protection Health

Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:
News & Analysis as of

University of Mississippi to Pay $2.75 Million for Alleged HIPAA Violations

On July 21, 2016, the Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) announced a settlement with the University of Mississippi Medical Center (UMMC), stemming from a 2013 breach of...more

FDA Issues Final Guidance on General Wellness Products

On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate “general wellness products,” including software applications, provided they present a...more

FTC Holds That Disclosure of Sensitive Medical Information Due to Lax Security Violates the FTC Act

Last week, three commissioners from the Federal Trade Commission (FTC) held in In the Matter of LabMD, Inc. that a company’s failure to implement reasonable security measures to protect sensitive consumer information on its...more

AMA Adopts Ethical Guidelines for Telemedicine Providers

At its annual meeting on June 13, the American Medical Association (AMA) adopted ethical guidelines for the use of telemedicine, affirming the organization’s support of the use of telemedicine technologies within the confines...more

FDA Issues Final Guidance for General Wellness Devices

The final guidance confirms FDA’s enforcement discretion for many fitness and wellness technologies but raises issues for certain testing services. On July 29, the US Food and Drug Administration (FDA) announced the...more

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

592 Results
|
View per page
Page: of 24

Follow Science, Computers & Technology Updates on:

JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×