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OCR Alerts Listservs About Fake Phishing Email to Covered Entities and Business Associates

On November 28, 2016, the Office for Civil Rights (OCR) issued an Alert to its listservs that a phishing email is being circulated on “mock HHS Departmental letterhead under the signature of OCR”s Director, Jocelyn Samuels”...more

Beware of Phishing Email Disguised as Official OCR Audit Communication

The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) has posted an alert (and a follow-up alert) warning health plans, health care providers, and their vendors of a mock communication...more

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

FTC Addresses Homeopathic Drug Advertising

The Federal Trade Commission (“FTC”) recently released an enforcement policy statement regarding marketing claims for products in the over-the-counter (“OTC”) homeopathic drug market. Long permitted to fly under the FTC’s...more

FDA Hosts Public Meeting on Off-Label Communications

The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more

FDA to Study Social Media Promotion

On November 7, 2016, FDA announced in the Federal Register its plan to research methods for including risk information about pharmaceutical and medical device products in promotional Internet communications that have...more

Managing the Transition to Transformation: Digital Health Solutions: Essential Ingredients in Alternative Health Care Delivery and...

INTRODUCTION - Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the...more

HHS Designates Cloud Service Providers as Business Associates Under HIPAA

Cloud service providers that process electronic protected health information (ePHI) are business associates under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), even if the PHI is encrypted and the...more

Cybersecurity and Data Privacy: Federal Agencies Issue New Guidelines and Rules for Data Breaches and Online Security (11/16)

After recent high profile data breaches and threats to online privacy—ranging from Yahoo Inc.’s data breach of approximately 500 million accounts to the hacking of Hillary Clinton’s campaign manager, John Podesta’s email...more

Malware Attacks Against Healthcare Sector Rose 67 percent in Q3 of 2016

The NTT Security Q3 Quarterly Threat Intelligence Report states that the healthcare industry is the fifth most targeted industry for ransomware (behind financial services, retail, manufacturing and technology) for all cyber...more

HHS Publishes New Guidance on HIPAA and Cloud Computing

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has issued a new guidance regarding HIPAA compliance and the use of cloud computing solutions. The guidance is intended to assist covered entities...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

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

The Tech Industry’s Next Frontier?

Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more

OCR Releases HIPAA Guidance on Cloud Computing

On October 6, 2016, the Department of Health and Human Services Office for Civil Rights (OCR) released HIPAA guidance on cloud computing (Guidance). The Guidance is intended to help covered entities and business associates...more

Ransomware? Don’t Pay It, Says FBI

What should companies do when ransomware hits? The FBI says: (a) report it to law enforcement and (b) do not pay the ransom. Given the recent onslaught in ransomware attacks—such as a 2016 variant that compromised an...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

Yuba Sutter Medical Center Hit With Ransomware

Yuba Sutter Medical Center in California (Yuba Sutter) has notified its patients that it has suffered a recent ransomware attack that caused parts of its network to be incapacitated. As a result, patient files were unable to...more

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

Manatt Digital - September 2016

Digital Health Continues to Grow - Investment into the digital health market topped $4.5 billion in 2015, and we are seeing an acceleration of investment in 2016. According to StartUp Health, investment into the digital...more

Health Care E-Note - September 2016

In an article published in the September 2016 MASA Newsletter, Jim Hoover and Angie Cameron Smith discuss how physicians should properly respond to subpoenas and requests for patients’ health information. They stress how...more

POM Wonderful Returns – Lanham Act False Advertising Claim Against Home Pregnancy Tests Not Precluded by FDCA

On September 9, 2016, the Court of Appeals for the Second Circuit issued an interesting decision in a false advertising case involving a dispute between competitors in the home pregnancy testing market. Church & Dwight Co. v....more

FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to...more

Health Alert (Australia) August 29, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 23 August 2016 - Secretary, Department of Health (as successor to the Secretary, Department of Social Services) v DLW...more

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

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