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OCR Warns of Phishing Campaign Disguised as Official OCR Communication

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Monday describing a phishing campaign disguised as an email from OCR. The email is being circulated on mock HHS...more

FTC Announces New Guidance on Ransomware

On November 10, 2016, the U.S. Federal Trade Commission (FTC) released new guidance for businesses and consumers on the impact of, and how to respond to ransomware. Ransomware is a form of malicious software that infiltrates...more

More on HIPAA Audits for 2016 and 2017–Desk Audits and On-Site Audits

As part of the ongoing HHS OCR HIPAA audit initiative, it is conducting “HIPAA desk audits.” These audits don’t involve auditors coming in your facility. Instead, covered entities are being asked to submit documents on...more

Cybersecurity 2017 – The Year In Preview: HIPAA Compliance

Editor’s Note: This is the third in a continuing end-of-year series. The year ahead promises to be a busy one for those with responsibility for HIPAA compliance, as the Office of Civil Rights (OCR), charged with...more

Awful Missouri Venue/Joinder Ruling Offers Way Out – Take It!

Even after having read it through twice, we find the result in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), hard to fathom, and even harder to stomach. For several years after...more

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

OCR Guidance Underscores Importance of Authentication under HIPAA

In its tenth OCR Cyber Awareness Newsletter of the year (Newsletter), the Office for Civil Rights (OCR) reminded HIPAA-covered entities and business associates of the importance of selecting an appropriate authentication...more

OCR Reminds Companies that Authentication is Key

In non-election news, the Office for Civil Rights (OCR) at the Department of Health and Human Services recently released its November Cyber Awareness Newsletter. This month’s newsletter focuses on the topic of...more

2016 Security of Things® Forum

The third annual Security of Things® Forum (SECOT) in Cambridge, Massachusetts fostered discussion on a variety of cyber-security related topics ranging from a standards-based approach to security connected devices to...more

Confusing Joint Guidance published by OCR and FTC on HIPAA Authorization Forms

There are arguments that there is a dearth of guidance by both the Office for Civil Rights (OCR) and Federal Trade Commission (FTC), so when guidance comes out, we listen. But the most recent guidance jointly issued by the...more

DOJ/FTC Joint Guidance for Human Resources Professionals Suggests Broad Antitrust Risks

Provisions restricting the hiring of another company’s employees are often included in vendor agreements and a variety of corporate transactions and licenses. And it’s not unusual to see similar constraints adopted in...more

Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

Federal Court Finds That 2015 TCPA Safe Harbor Applies to Automated Flu Shot Reminders

A recent decision from a federal court in California found that a retail pharmacy’s “flu shot reminder” calls to mobile phones fall within the FCC’s TCPA safe harbor for exigent health care treatment messages. But the holding...more

Sharing Consumer Health Information? Look to HIPAA and the FTC Act

Does your business collect and share consumer health information? Check out these tips from the FTC for complying with HIPAA and the FTC Act....more

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

HHS-OCR Announces Guidance On HIPAA Compliance And Cloud Computing

On October 6, 2016, the Department of Health and Human Services Office for Civil Rights (“OCR”) issued guidance on complying with HIPAA privacy, security, and breach notification rules when using cloud computing technology...more

New OIG Studies Reveal Clinical Lab Test Payment Trends and CMS’ Progress in Implementing PAMA

Last week, the OIG released two new studies analyzing what and how Medicare pays for clinical laboratory tests (“lab tests”). The first study, Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of...more

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes”

On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more

FDA Proposes to Modify Good Laboratory Practice Regulations, Broaden Application and Authority

On August 24, 2016, the US Food and Drug Administration (FDA) issued a Proposed Rule on Good Laboratory Practice for Nonclinical Laboratory Studies (Proposed Rule), which broadens the application and authority of Good...more

Better Healthcare Newsletter from Patrick Malone - October 2016

That electronic device in your palm has become more than your best friend. Half the adults around the world have become so addicted to their smart phones that wags say we are a new species: Phono sapiens. Can our phones...more

FDA Regulatory and Compliance Monthly Recap — September 2016

FDA issues final rule modifying regulations for drug establishment registration, listing requirements - The final rule, which comes nearly 10 years after changes were initially proposed, updates the regulations to...more

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

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