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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As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest.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

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

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

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

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

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

NIST Issues Draft Report Enumerating Risks and Protections to Consider When Evaluating Mobile Apps for Your Enterprise

As the world recovers from the excitement leading up to Tuesday’s Apple Live Event announcement of the new iPhone 6 and Apple Watch, mobile app developers are chomping at the bit to create software that leverages the new...more

Data protection authority investigates eHealth and wellness/fitness apps

eHealth and fitness/wellness applications are being investigated and potentially sanctioned by the Italian data protection authority that found half of them not compliant with applicable privacy laws....more

New FCC Rules for Medical Body Area Networks

On August 21, 2014, the Federal Communications Commission (“FCC”) released an Order with new and clarified rules to foster the development and deployment of Medical Body Area Networks (MBANs). The Order provides more...more

Driving Down the Cost of Health Care Through Next Generation Networks

Current and future health care delivery models are quickly outgrowing legacy communications architectures, which lack the structural flexibility and, more importantly, the control and security of Next Generation Networks, or...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

Capital Thinking: Technology and Communications

Legislative Activity - House Commerce SUBCommittees Will Hold Hearing ON 21st Century Technology for 21st Century Cures - The House Energy and Commerce Subcommittees on Communications and Technology and Health...more

FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media. One of the guidance documents addresses how...more

FDA Offers Guidance for Choosing Prescription Drug Names

If you've seen your share of prescription drug commercials, you've likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations...more

China’s National Auditing Office Notes Compliance Concerns with Sponsorship of Academic Conferences in the Healthcare Sector

In China, it is common industry practice for pharmaceutical companies to sponsor academic conferences. As long as such events are aimed at enhancing the practice of medicine and patient welfare, the practice has been allowed....more

Coveting Characters: Navigating FDA's Draft Guidance on Social Media

Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more

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