Communications & Media Health

Read need-to-know updates, commentary, and analysis on Communications & Media issues written by leading professionals.
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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

Is Marriage a “Material Connection”? The FTC Challenges an “Independent” Expert Based on Marital Status

Medical endorsements can be powerful selling tools for health care products. But if a medical professional has a connection to the company marketing the products that would be material to consumers in evaluating the...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

Ten Things to Know About the CMS Long-Term Care Requirements Final Rule

Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more

Don't Post That! Protecting Patient Privacy in the Age of Social Media

Social media has great utility for urgent care centers, providing invaluable opportunities to connect with the local community, and offering a host of educational tools for providers and patients. The explosion of myriad...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

Amendments to Ontario’s Calorie Disclosure Requirements

Ontario’s Ministry of Health and Long Term Care recently announced amendments to the regulations (Regulations) under the Healthy Menu Choices Act, 2015 (Act), which, among other things, add new categories of items exempt from...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

California Legislative Update: Which Bills Made the Final Cut?

Although the California Legislature sent Governor Jerry Brown bills on bed bugs, powdered alcohol, and making denim the official state fabric, the laws enacted in 2016 affecting the state’s private-sector employers were...more

FTC Bureau Director Highlights Continuing Health-Related Enforcement, Homeopathic Guidance, and ROSCA at NAD Conference

Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, highlighted the agency’s enforcement priorities at the National Advertising Division’s annual conference earlier this week. Key mentions included the...more

Part I - TCPA: Regulatory - Calls By or on Behalf of the Federal Government

A number of organizations filed comments and/or reply comments regarding the National Consumer Law Center (“NCLC”)’s Petition for Reconsideration of the Broadnet Declaratory Ruling, which asks that the FCC reconsider its...more

FDA to Redefine “Healthy;” Requests Public Comment and Issues New Guidance

FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.” Today, it announced the beginning of the formal process to make changes to the definition of the...more

Dialing for Dollars Yields Conviction for Home Health Telemarketer

Sundae Williams, the owner of Serenity Marketing Inc., made unsolicited phone calls to recruit patients, including Medicare beneficiaries, for contracted home health agencies. Williams and Serenity then referred those...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

CMS Warns Against Social Media Postings Involving Nursing Facility Residents

In an August 5, 2016, Survey and Certification memorandum to state Survey Agency Directors, the Centers for Medicare and Medicaid Services (CMS) directs surveyors of nursing facilities on matters relating to the use of social...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

Summer Vacay? Not for FDA.

While you were (hopefully) lounging at the beach or hiking mountains, the FDA was hard at work in Washington D.C. churning out final rules and guidance documents that impact food companies in various, and sometimes...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

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