Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English)
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Following the Social Media Rules for Pharma and Medical Device Companies

Following the Social Media Rules for Pharma and Medical Device Companies | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it

"To tweet or not to tweet?" is often the question for pharmaceutical and medical device companies when it comes to advertising their products in the burgeoning social media environment.

The very specific rules the U.S. Food and Drug Administration has regarding marketing for drugs and devices makes it difficult to market products on platforms like Twitter, Facebook and blogs. Counsel representing these companies should be familiar with several interpretive guidance documents the FDA released last year that help explain the agency's thinking as it grapples with emerging and future social media platforms. The issuance of guidance on social media was required by the 2012 "Food and Drug Administration Safety and Innovation Act" (FDASIA), Section 1121. This required the FDA to, by August 2014, "issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by [the FDA]." The FDA complied and issued three sets of guidance related to social media in 2014, with two more still pending. Though these guidance documents are not regulations, they represent the FDA's current thinking and best practice is to follow and comply with them.

Spatially Challenged

One of the guidance documents addresses social media platforms with limited character spacing. The most common example of such a platform is Twitter, which is limited to 140 characters for a single tweet. The FDA guidance says that if an "accurate and balanced" presentation of both risks and benefits is not possible within the constraints of the specific platform, the company should reconsider using that platform. In other words, if a company cannot present both the benefits and the warnings and risks about a product in the space provided, it should not advertise it there.

The FDA rules on labeling govern how a company is allowed to market its product. The agency requires company advertising to meet several requirements: be truthful and non-misleading (FD&C Act 502(a), 201(n)); include certain information, such as the indicated use and risks (21 CFR 201.100(d), 201.105(d), 801.109(d)); be prominently placed on the label; and any advertisement that makes representations about drugs must include certain risk information (502(n), 21 CFR 202.1). Advertising on social media must be presented in a fair and balanced way.

Handling Misinformation

Most of us are familiar with Internet "trolls," those sometimes angry and often misinformed commenters to online articles or blog posts. What happens, however, when someone posts something online about your client's medical device or drug that is false? What if, say, this person posts that the drug is dangerous and caused Side Effect X and killed his elderly mother who had diabetes? What if the company knows the drug does not cause Side Effect X, or the drug was specifically labeled warning people with diabetes to not take it? It is these types of situations where a company may feel the need to say something—so others do not take the drug incorrectly and to protect its brand.

The FDA has issued guidance on this type of situation. The agency understands a company cannot be the sheriff of the Internet and correct, much less know about, each instance of someone saying something wrong about a company's product. Its guidance states a company is not responsible for user-generated content on social media platforms it does not operate or control. This means that if misinformation is generated in a tweet or Facebook post, the company has the option, but not the obligation, to post something and correct the misinformed poster. However, if the post is on the company's page, or in a forum the company hosts, then it is responsible for setting the record straight.

Whether the company is obligated to respond to misinformation or voluntarily chooses to respond, the FDA guidance sets forth the following specific things the company must do when responding.

1. Be relevant and responsive to the misinformation

2. Tailor the message to the misinformation

3. Be non-promotional in nature, tone and presentation

4. Be accurate

5. Be consistent with the FDA-required labeling

6. Be supported by sufficient evidence

7. Post in conjunction with the misinformation in the same area or forum

8. Disclose the person providing corrective information affiliated with the company that makes the product

Legal Implications of Social Media Rules

The FDA guidance leaves open the issue of liability faced by drug and device companies, even if complying with the rules. Specifically, "failure to warn" claims are possible for a company advertising on social media. Even if it complies with the FDA guidance, a company can still face liability over its labeling. If, for example, a company decides to tweet and tries to highlight the use of the drug with its risk, what if it only includes the most significant risk and not others? Will that expose the company to a failure to warn claim?

In addition to product liability, social media advertising raises the issue of competitors having the ability to bring suit under the Lanham Act (15 U.S.C. §1525). This law allows a private right of action so a party may sue a competitor for any false or misleading description or representation of fact which

" … in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person's goods, services or commercial activities." Pharmaceutical companies can face Lanham Act liability for many types of claims, including minimizing risks, broadening indications, overstating efficacy and making comparative claims in the absence of supporting head-to-head clinical data.



Read more: http://www.therecorder.com/id=1202721749266/Following-the-Social-Media-Rules-for-Pharma-and-Medical-Device-Companies#ixzz3VZElZUQy

 


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Social Networking Could be Used to Tackle Depression

Social Networking Could be Used to Tackle Depression | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Still in development stage, the platform Panoply created "significant benefits."

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PR to pharma: up your dosage of social media

PR to pharma: up your dosage of social media | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Many pharma companies remain concerned about running afoul of the regulators with their online activities and therefore have not yet fully embraced new channels. However, increasingly patients want and expect them to engage, and those that have are...
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Take Two Aspirin And Tweet Me In The Morning: How Twitter, Facebook, And Other Social Media Are Reshaping Health Care


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Over 50% Of Mobile Health Apps Are Downloaded Less Than 500 Times

Over 50% Of Mobile Health Apps Are Downloaded Less Than 500 Times | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
That's the finding of a new report on mobile health apps by IMS Institute for Healthcare Informatics (free PDF here).  In true mobile fashion, it's also available in the iTunes store (here). Some of the other results of the recent study included these: 1. Every app categorized as "health and wellness" or "medical" [...]

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Genetic testing: The next employee benefit?

Genetic testing: The next employee benefit? | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
SOURCE December 17, 2014 Organizations often look to their benefits for innovative ways to differentiate themselves from others as they compete for talent. A look to recent developments in the very competitive U.S. technology sector had Apple and Facebook covering the cost of the elective cryogenic freezing and storage of eggs for female employees. In response (or retaliation), Google announced that its plan would also include a new benefit for all employees: genetic testing. Beginning in January, Google’s benefits plan will include coverage for two DNA tests from Foundation Medicine that look specifically for solid tumours, pediatric cancers and blood malignancies, and help oncologists make decisions on chemotherapy regimens based on a patient’s genetic profile. While this addition is specifically focused on cancer and cancer markers, there are certainly murmurings of interest in providing broader spectrum genetic testing as part of a benefits plan. One of the questions in this year’s
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Will 2015 Be the Breakout Year for mHealth? mHealth Summit | 2015 | HealthWorks Collective

Will 2015 Be the Breakout Year for mHealth? mHealth Summit | 2015 | HealthWorks Collective | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
While on the one hand, many are proclaiming 2015 to be the year that mHealth finally becomes mainstream, the opening day keynote at the mHealth Summit last week at the Gaylord National Harbor Convention Center seemed to suggest we are in the trough of disillusionment.
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Pharma companies want to add an app to your next prescription

Pharma companies want to add an app to your next prescription | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Pharmaceutical companies reported to be establishing a digital health collaborative; may add apps to your next prescription.
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Pharma Marketing Blog: Is IMS Health's Mobile Health App Certification Program Doomed to #FAIL?

Pharma Marketing Blog: Is IMS Health's Mobile Health App Certification Program Doomed to #FAIL? | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
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In-Depth: News, novel quotes, and notable trends from the mHealth Summit 2014 | mobihealthnews

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Hype Around Healthcare Wearables Runs Into Reality

Hype Around Healthcare Wearables Runs Into Reality | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it

Makers and boosters of wearable technology have had a few reality checks lately.

Late last month, while we Americans were enjoying the long Thanksgiving weekend and/or indulging in the Black Friday retail frenzy, Juniper Research over in the UK was putting out a report forecasting that fitness devices, not true health monitors would “dominate the wearables market” worldwide until at least 2018. Those likely will be of limited use in the wider picture beyond fitness.

“The key is making the devices provide meaning as well as data—counting steps is all very well, but will not keep consumers interested unless that information can be contextualized and made useful for them,” Juniper Research Analyst James Moar said in an interview with FierceMobileHealthcare.

On Tuesday, Dr. Joseph Kvedar, director of the Center for Connected Health at Boston-based Partners HealthCare, opened the annual mHealth Summit in Oxon Hill, Md., with a caution about “irrational exuberance,” according to several published reports.

As mHealth news reported, Kvedar said that nobody has figured out how to make consumers — patients — care about mobile health technologies. “And if we don’t [figure that out], m-health will be another tech bubble,” Kvedar was quoted as saying.

That is not far off from what Dr. Matt Patterson, president of AirStrip Technologies, a San Antonio-based maker of mobile patient monitoring software, said last Thursday at the 11th annual (and likely final, due to declining interest) Healthcare Unbound conference in San Diego. ”I can tell you right now doctors do not care about your Fitbit data,” Patterson said.

Consumers eventually stop caring, too. ”Surveys have found that half who use mobile fitness trackers to keep tabs on their workouts or diets stop using the programs within six months,” said a recent Los Angeles Times story on smartphones in healthcare. (It would have been nice for the Times to cite its sources, but the point is taken.)

Patterson suggested that consumers and providers alike still do not see much value in such technologies, a common reason for apathy toward some technologies in healthcare. ”I think innovation in healthcare results from clinical transformation where the economics of value and incentives are aligned,” he said.

Data has to “take a lot of work out of the situation” and be actionable for physicians to care about it, and it has to be aligned with the incentives, Patterson said. At the moment, Fitbit data does not do that, he suggested.

All these wearable and mobile products, touted as “disruptive,” “revolutionary” or “groundbreaking” by so many vendors and Silicon Valley cheerleaders still haven’t proved value to healthcare providers or large number of consumers. Eventually, they will have to, or Kvedar will be right about a bubble.

 

 


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Apple HealthKit sparks security concerns | Healthcare IT News

Apple HealthKit sparks security concerns | Healthcare IT News | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Despite what seems to be some sustainable momentum beyond the initial rush of excitement, worries remain about Apple's HealthKit platform -- with security concerns and its potential to flood doctors with unnecessary data topping the list. Could the latest big thing eventually go the way of Google Health?
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A Social Network Designed to Combat Depression | WIRED

A Social Network Designed to Combat Depression | WIRED | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Panoply is a crowdsourced website for improving mental health, created at MIT.
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Infographic: SXSW Health Tech Trends - HIT Consultant

Infographic: SXSW Health Tech Trends - HIT Consultant | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Phillips illustrates how data, connectivity and innovation are changing the healthcare landscape, as well as the key health tech trends throughout this year
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PwC Report : Global health’s new entrants Meeting the world’s consumer (march 2015)

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Why health wearables will shift from the wrist to the ear

Why health wearables will shift from the wrist to the ear | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
While wearables primarily are buckled to consumers' wrists at this point, they'll soon find a new home: the ear, says Craig Stires, associate vice president for big data, software and analytics at IDC Asia Pacific. And they might even get a new moniker: hearables.
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When medical apps do more harm than good

When medical apps do more harm than good | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Replacing clinic visits with smartphones can be a risky move. Here's why.
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Fitness Trackers Are Everywhere, but Do They Work?

Fitness Trackers Are Everywhere, but Do They Work? | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
In other words, the accuracy really makes little difference; the point is to keep us aware, to gamify our efforts. In that way, these bands really work. You wind up parking farther away, getting off the bus a stop earlier, going for a walk down the block to bring your 9,374 daily step count up to your 10,000-step goal.

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Healthcare dominates Google's venture investments in 2014

Healthcare dominates Google's venture investments in 2014 | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Healthcare accounted for 36 percent of Google Venture investments in 2014 in 12 companies spanning diagnostics, predictive analytics, telemedicine.
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5 digital health trends you'll see in 2015

5 digital health trends you'll see in 2015 | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
As funding for health-minded technology skyrockets, innovators are turning medical knowledge into usable tech.

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10 social media events that changed healthcare in 2014

10 social media events that changed healthcare in 2014 | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
This month, Daniel Ghinn reviews some of the key online happenings that have had an impact on healthcare over the year. The year 2014 has been incredible for social media in healthcare. Consumers and patients have taken on industry and regulators...

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How The American Diabetes Association Is Using Social Media

How The American Diabetes Association Is Using Social Media | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Find out how the American Diabetes Association is using social media to reach their community of patients.
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Can A Virtual Clipboard Automate the Patient Intake Process?

Can A Virtual Clipboard Automate the Patient Intake Process? | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
Healthcare reps meet to discuss developing a "virtual clipboard" that will “create an industry blueprint around how to automate the patient intake process.
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Why Is Measuring Data About Your Condition Worth It?

Why Is Measuring Data About Your Condition Worth It? | Health, Digital Health, mHealth, Digital Pharma, hcsm latest trends and news (in English) | Scoop.it
This is not a new story but I'm always fascinated when I read it again and again. Doug Kanter measured data about his life, his condition, blood sugar levels and every details that could have been ...
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