Communications & Media Health

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

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

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

Drug Treatment Centers Must Walk a Fine Line With Respect to Marketing

A recent New York Times article entitled “How Staten Island’s Drug Problem Made It a Target for Poaching Patients,” details how recruiters for treatment centers as near as Long Island and upstate New York, and as far away as...more

Locky Ransomware Continues to Hit Health Care Entities

FireEye Labs has reported that the Locky ransomware continues to hit the health care industry hard, and has increased in the month of August. Although the telecommunications, manufacturing and aerospace/defense...more

Agencies Encourage New Privacy Regulations to Close the mHealth Black Hole and Keep Pace with Evolving Technologies

On July 19, 2016, the ONC submitted a report to Congress which suggests that health privacy regulations soon may be revised to catch up with the universe of mHealth technologies that now use and share personal health data....more

Nursing Facilities to Face Surveyors’ Review of Photo and Video Policies

The Centers for Medicare and Medicaid Services (CMS) this month took aim at the unauthorized taking and sharing of photos and videos – including through social media – in nursing facilities. In response to media reports and...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

Hold it, Doctor! Don’t Hit the Send Button!

The Joint Commission made a big splash when it issued its “Update: Texting Orders” back in the spring. That Update rescinded the accrediting organization’s long-standing prohibition on sending physician orders via text...more

Final Order against Practice Fusion Approved by FTC

On August 16, 2016, the Federal Trade Commission (FTC) approved the final order resolving its privacy complaints against Practice Fusion. The complaint alleged that Practice Fusion “misled consumers by soliciting reviews for...more

CMS Cracks Down On Social Media Abuse By Nursing Home Staff

On August 5th the Centers for Medicare & Medicaid Services (CMS) issued a memorandum to all state survey agencies requiring that during the next standard survey of a nursing home, whether a Traditional or Quality Indicator...more

Your daily dose of financial news - The Brief – 8.18.16

A SDNY jury has found former JPMorgan banker Sean Stewart guilty of insider trading based on allegations that Stewart was leaking confidential information about health care company mergers to his dad....more

Brewers’ Voluntary Disclosure Initiative Introduced

As the food and beverage industry trends toward products and practices that promote consumer choice and transparency, the Beer Institute has recently announced a new Voluntary Disclosure Initiative (the “Initiative”), which...more

You Wear It Well (or Do You?): FDA Objects To These Skincare Companies’ Unapproved New Drug Claims

In the 1972 hit, “You Wear it Well,” Rod Stewart sang about a woman and offered the classic line, “Madame Onassis got nothing on you.” The tune came to mind when reading four Warning Letters issued by the Food and Drug...more

CMS Issues Warning to Nursing Homes Regarding Abuse of Residents Via Social Media

On August 5, 2016, the Centers for Medicare & Medicaid Services (CMS) issued guidance to nursing homes in a letter to state survey agencies that addresses nursing homes’ obligations to protect residents. The Letter focuses on...more

President Obama Signs Federal GMO Law, Preempts Vermont Law

On July 29, 2016, U.S. President Barack Obama signed into law the first U.S. federal law requiring food manufacturers and distributors to label products that contain genetically modified organisms (“GMO”).[1] The law...more

Mobile Apps - Has the Marketplace Downloaded Potential Product Liability Risk?

For many consumers, it is hard to remember performing a daily routine without using a mobile application. App usage starts almost immediately - with a morning alarm that wakes you up slowly or with a coffee waiting for you at...more

FCC Launches Mapping Tool to Drive Broadband Healthcare Solutions

This Tuesday, the FCC’s Connect2Health Task Force unveiled its Mapping Broadband Health in America tool which permits users to “visualize, overlay, and analyze broadband and health data” at the national, state, county and...more

FDA Issues Final Guidance on General Wellness Products

On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate “general wellness products,” including software applications, provided they present a...more

JCAHO Delays Decision Allowing Physicians To Text Orders

We previously reported that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) lifted its ban on allowing health care providers to use texts for physician orders....more

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