Health Communications & Media

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Changes of the Amended Regulations on Supervision and Administration of Medical Devices

The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

The FDASIA Health IT Report

On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by...more

The regulation of cosmetic interventions in the UK: toothless rhetoric or industry overhaul?

This Reed Smith client alert looks at the UK government’s response to the independent review of the regulation of cosmetic interventions in the UK. The key issues In recent years, cosmetic procedures have become widely...more

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

Mobile Medical App Regulations on the Move – Proposed Bills To Further Alter the Regulatory Landscape of Mobile Medical...

Apple’s apps store lists close to a 100,000 health apps. Together with wearable technology, direct-to-consumer testing services, and greater consumer participation in the decision to purchase health insurance, the healthcare...more

After Arkansas Supreme Court Reverses $1.2 Billion Medicaid False Claims Verdict, Will State Attorneys General Rethink the Use of...

On March 20, 2014, the Arkansas Supreme Court reversed a $1.2 billion judgment against Johnson & Johnson and its related companies over alleged Medicaid fraud stemming from the off-label marketing of the drug Risperdal. This...more

How Much Are You Willing To Pay For Privacy?

How much are you willing to pay for personal privacy? 50% off a McDonald’s hamburger? 20% off groceries? Participation in the $1 Billion NCAA Tournament Bracket Challenge?...more

Your smartphone is NOT a medical device

Wearable technology issues relating to the potential qualification of such products as a medical devices have become popular on the press following the presentation of the first smartphone with a heart rate sensor, quickly...more

FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of...

The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more

FTC Settles Case With Medical Transcription Company

The Federal Trade Commission (FTC) recently announced that it had settled its data privacy case against medical transcription firm GMR Transcription Services, Inc. (GMR) following allegations that GMR had failed to adequately...more

Draft FDA Guidance on Real-Time Promotional Statements Made Via Social Media

In January 2014, the US Food and Drug Administration (FDA) gave the pharmaceutical industry another glimpse of its thinking on social media marketing. The agency’s draft guidance, titled “Fulfilling Regulatory Requirements...more

@FDA Gives Little Guidance 2 #Pharma re Social Media

The way that we communicate has changed. Technology and social media have altered how we keep in touch with friends and family. Whether it is a text message that you will be late for dinner, a Tweet about breaking news, or an...more

FDA Revises Draft Guidance Concerning Distribution of Scientific and Medical Publications for Drug and Device Manufacturers

Updating policies established in a 2009 Guidance, the Food and Drug Administration (FDA) has released a draft version of a proposed 2014 Guidance addressing the use of medical publications in promoting "off label" uses of...more

FDA Seeks Public Comment on Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved...

On March 3, 2014, the U.S. Food and Drug Administration ("FDA") made available for comment a revised draft of its "Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended...more

Food Labeling Client Alert: FDA Proposes Changes to Iconic Nutrition Facts Label

The U.S. Food and Drug Administration (FDA) recently proposed an update to the iconic Nutrition Facts label for packaged foods. In light of new scientific evidence about human health and nutrition, dietary recommendations of...more

FDA Updates Guidance Addressing Distribution of Scientific and Medical Publications on Unapproved New Uses

On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.” The draft guidance,...more

FDA Updates Reprint Guidance, Reiterates Narrowness of Off-Label Safe-Harbor

FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more

Some Things Better Left Unshared: Social Media and Medical Identity Theft

The Washington Post recently published an article reminding individuals not to tweet or otherwise share information concerning their medical conditions on social media, warning that disclosing such information publicly “is...more

FDA Releases Revised Draft Guidance on the Distribution of Scientific and Medical Publications About Unapproved Uses: Guidance...

On March 3, 2014, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (“Revised Draft...more

New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

FDA Issues Revised Draft Reprints Guidance

On February 28, 2014, the Food and Drug Administration (“FDA”) released a revised draft guidance for industry entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“Revised...more

Marketing to Medicaid Beneficiaries: Texas Proposed Rule Highlights Pitfalls for Providers

Earlier this month, the Texas Health and Human Services Commission (Commission) released a proposed rule, 1 TAC § 354.1452 that prohibits certain marketing activity by Medicaid and CHIP providers. The proposed rule has been...more

A Guide to FDA Postmarketing Submission Requirements and Reporting Interactive Promotional Media

As part of existing FDA postmarketing reporting requirements, manufacturers, packers, and distributors that are FDA applicants or that act on behalf of FDA applicants (for simplicity, “Applicants”) are required to submit all...more

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