Health Communications & Media

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Patient Medical Records Stolen from New Jersey Storage Facility – Tribeca Medical Center is notifying patients that their protected health information may be compromised. According to a privacy notice posted on Tribeca...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

Refill Reminders and the TCPA

The Telephone Consumer Protection Act (“TCPA”) presents another challenge as health care providers continue to engage patients and seek to meet Meaningful Use reminder objectives. Over the past year, there have been several...more

FDA Issues Much Anticipated Final Rules on Menu and Vending Machine Nutrition Labeling

The U.S. Food and Drug Administration (FDA) recently published the long awaited final rules on menu and vending machine nutrition labeling. The rules implement section 4205 of the Patient Protection and Affordable Care Act...more

Florida, No Grants For You!

In November 2014, the federal government’s Distance Learning and Telemedicine (DLT) program awarded over $10 million in grants to support telemedicine and rural health research. The list of 65 DLT grant recipients included...more

October Digital Health Investments Dominated by Diagnostics and Therapeutics

Digital health companies raised just over $730 million through venture, private equity and angel investments in September, according to our latest analysis, bringing the total for the third quarter to approximately $1.3...more

Final Menu Labeling Rules Released by FDA

The U.S. Food and Drug Administration (FDA) released two final rules for menu and vending machine labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive...more

Health Update - November 2014

“Healthcare-Related” Calls: Ambiguity at the Intersection of HIPAA and TCPA - Editor’s Note: The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer...more

Will the Mid-Term Elections Help Telemedicine Reimbursement?

Our recent survey of senior-level health care executives reinforced that lack of reimbursement remains the primary barrier to providers in adopting telemedicine services. Of our respondents, 41 percent indicated that their...more

The New Promotional Rules: “There Are No New Promotional Rules”

There is resounding evidence that physicians and patients rely on the Internet—including social medial platforms—to research and communicate health information. FDA, however, has been slow to adapt even though the potential...more

The Employment Law Authority - October/November 2014

In This Issue: - Employee Benefits. Recent IRS letter reminds employers about issues associated with offering “free” parking - State Round-Up. Learn about the latest employment law news in your state -...more

Privacy Tuesday – November 2014 – Five Things to Start Your Week

Welcome to Privacy Tuesday – here are five privacy & security bits and bytes to start your week: 1) California AG’s Data Breach Report: Who Is Handling Your Patients’ Confidential Health Information? - The...more

Whistleblowers Must Have Independent Knowledge to Actually Blow the Whistle

To bring a valid qui tam action and overcome the so-called “public disclosure bar” under the False Claims Act (“FCA”), a whistleblower must have direct knowledge of the alleged fraudulent activity, independent of already...more

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical Companies to Find Users?

Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma)...more

mHealth Technology – Development in an Uncertain Regulatory Climate

The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more

Status Updates - October 2014 #8

..Doctor in the mouse. What if you could input a list of your current symptoms to Google, and quickly be connected with a doctor for a brief consultation? For a limited trial period, Google seems to have set up such a system...more

‘Health Care’-Related Calls: Ambiguity at the Intersection of HIPAA and TCPA

The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer Protection Act (TCPA) for health care messages regulated under the Health Insurance Portability and...more

Recent 11th Circuit Cases Provide Important HIPAA Guidance - Healthcare Providers Should Be Proactive by Reviewing Their HIPAA...

On Oct. 10, 2014, the 11th Circuit opinion in Murphy v. Dulay provides significant guidance regarding HIPAA authorization forms. One of the most important provisions of the opinion focuses on the fact that HIPAA...more

Eleventh Circuit Holds That Debt Collector Had “Prior Express Consent” From Debtor Whose Wife Provided Number on Hospital...

This week the Eleventh Circuit held that a debt collector had “prior express consent” from a debtor whose wife had provided his wireless number on a hospital admission form. Mais v. Gulf Coast Collection Bureau, Inc., No....more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

Health Reform + Related Health Policy News - September 2014, Issue 1

In This Issue: - Top News ..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections ..Physician Supervision Requirement for Small and Rural Hospitals ..CMS Offers Hospitals...more

Mobile Health Technologies Rake in Largest Digital Health Investments of August

The top five digital health investments in August accounted for nearly half of the venture, private equity and angel investments in the sector during the month. Five companies raised $139 million of the $286.8 million...more

Dot-com: A Health Professional's Website Is Not Just Another Website

Many physicians and other health professionals maintain a robust Internet presence, including websites and portals to provide patients with information. However, I was recently reminded of how easy it is to overlook the...more

NIST Vetting Guidance Valuable for Health Care Organizations Seeking to Use Third-Party Apps

The mobile app and wearables market in health care is booming, most recently evidenced by Apple’s entry into the market with its widely-anticipated “HealthKit,” a purportedly secure platform that allows mHealth apps to share...more

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