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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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more
Earlier this month, the FDA released proposed two-part Guidance on Internet and social media intended to assist prescription drugs and medical device manufacturers to accurately communicate online about their products. The...more
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