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

20 Days Left to File Your Annual HIPAA Breach Report

Did your organization experience a HIPAA breach involving fewer than 500 individuals in 2015? If so, remember to submit your mandatory report to the Secretary of HHS no later than February 29, 2016, through the online breach...more

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

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing...more

Electronic Monitoring Notification and Consent Form Released

The Illinois Department of Public Health has released the Electronic Notification and Consent Form on Friday, January 29, 2016. The Authorized Electronic Monitoring in Long-Term Care Facilities Act (Public Act 099-0430)...more

Postmarket Cybersecurity Recommendations for Medical Devices Issued by the FDA

We’ve blogged about medical device cybersecurity topics. The topic is in the news yet again with the FDA issuing a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity...more

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity.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On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details...more

FDA Releases Draft Guidance for Medical Device Cybersecurity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

FDA Proposes Public Notification of “Emerging Signals”

The Food and Drug Administration has proposed a new policy for earlier public notification of medical device safety issues. These notifications will be in addition to the recall notices, safety communications, and press...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 Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...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

Texas Medical Board Appeals Immunity Ruling

In a notice of appeal filed on January 8, 2016, the Texas Medical Board appealed the Western District of Texas’s ruling that the Texas Medical Board was not entitled to state action immunity in an antitrust suit involving...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

Laboratory Developed Tests Emerging in FDA Regulation

Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer,...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

Henry Schein Settles FTC Charges of Deceptive Advertising of Dentrix G5

Data encrypted in accordance with the Advanced Encryption Standard (“AES”) gives dentists a “safe harbor” in the event of certain breaches of patient information. However, those relying on Henry Schein’s Dentrix G5 software...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

FDA Regulatory and Compliance Monthly Recap — December 2015

Pacira secures expanded marketing for painkiller medication as FDA agrees to settle lawsuit, revoke warning letter - The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses,...more

Federal Spotlight Continues to Shine on Physician-Owned Distributorships

A recent Senate Finance Committee hearing investigated the effects of physician-owned distributorships (“PODs”) on costs of care and patient safety, suggesting that the momentum for greater oversight of such business...more

Quest Defeats Claims that It Conspired with Health Insurers

On November 25, District Court Judge William Orrick (N.D. Cal.) dismissed all claims in Eastman v. Quest Diagnostics, finding that the plaintiffs, a class of Northern California consumers who had utilized Quest's services,...more

473 Results
|
View per page
Page: of 19

Follow Science, Computers & Technology Updates on:

"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.
×