Consumer Protection Health

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Additional Clarification regarding HHS OCR Phishing Email Alert

More information from HHS OCR about the phishing threat... ..On November 28, 2016, the HHS Office for Civil Rights issued a listserv announcement warning covered entities and their business associates about a phishing...more

OCR Provides Additional Clarification on Phishing Scam

As we reported earlier this week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights described a phishing campaign that is attempting to convince recipients of their inclusion in OCR’s Phase 2...more

HHS OCR Alert: Phishing Email Disguised as Official OCR Audit Communication

This alert just in from HHS OCR: “It has come to our attention that a phishing email is being circulated on mock HHS Departmental letterhead under the signature of OCR’s Director, Jocelyn Samuels. This email appears to...more

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

Health Update - November 2016

Post-Election Analysis: Healthcare Antitrust in a Trump Administration - In a Republican sweep of all the elected branches of the federal government, Donald Trump won the presidential election and Republicans retained...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

Appeals Court Decisions Strengthen FTC's Hand in Hospital Merger Challenges

The fall of 2016 has proved to be a difficult time for hospitals seeking to complete mergers in the face of antitrust challenges brought by the Federal Trade Commission (FTC). After failing initially to persuade federal...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

FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade...more

FTC's Winning Streak Restored: Seventh Circuit Reverses Denial of Preliminary Injunction in Chicago Hospital Merger, Competition...

Recent appellate decisions confirm the uphill battle hospitals face when merging with other hospitals. On October 31, the U.S. Court of Appeals for the Seventh Circuit overturned the district court’s ruling in Federal Trade...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

Into the Cloud: New Guidelines for HIPAA Covered Entities and Business Associates

The advent of cloud computing has raised questions about how companies subject to HIPAA can take advantage of the technology while still complying with their privacy and security obligations under federal law. In response,...more

CMS Releases the First Comprehensive Overhaul of Nursing Home Conditions of Participation in Over 25 Years

On October 4, 2016, the Center for Medicare and Medicaid Services (CMS) published a final rule to revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. CMS...more

TCPA Update - October 2016

We are pleased to present the latest edition of Monthly TCPA Digest, bringing you insights on TCPA regulatory and legislative updates, class action developments, and trends. If you have suggestions for content you would like...more

FTC Scores Another Victory in FTC v. Advocate Health Care Network

The Federal Trade Commission (FTC) won another decisive victory in its effort to fight health care provider consolidation when the U.S. Court of Appeals for the Seventh Circuit reversed a district court’s decision denying 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

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