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The FDA’s Consent Form Language – ‘Understandable’ or Not?

The FDA’s Consent Form Language – ‘Understandable’ or Not? | FDA Guidance | Scoop.it
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FDA offers new draft guidance on informed consent process

FDA offers new draft guidance on informed consent process | FDA Guidance | Scoop.it
For the first time since 1998, the US FDA is offering draft guidance
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FDA's social media guidance: Better late than never

FDA's social media guidance: Better late than never | FDA Guidance | Scoop.it

Not only are today's healthcare consumers and patients relying more on the Internet to seek out information, locate needed medical experts and keep up on latest research and treatments, they're also sharing what they learn through an increasing number of social media outlets, including Facebook and Twitter.

Social media technologies provide users with quick and fast sharing capability and the potential to reach a huge swath of other users. The sites also afford the same capabilities to healthcare providers, vendors, pharmaceutical companies, payers and everyone else within the healthcare industry.

 

To that end, it's nice to see the U.S. Food and Drug Administration (FDA) finally catch up with how consumers and patients are sharing information online, especially since medical device manufacturers, pharma companies and other healthcare professionals are are doing the exact same thing.

In drafting a new federal guidance document on social media use, FDA offers medical device manufacturers and pharmaceutical companies insight on how to share benefit and risk information on 23 electronics digital platforms, ranging from Twitter and blogs to online paid search programs. Specifically, it calls for a balance between risk and benefit information posted to online platforms.

The guidance arrived several months after the FDA announced its intention to track social media talk about product risks. "The objective of this requirement is to provide FDA with the resources needed to use social media to inform and evaluate FDA risk communications," a solicitation notice published to the Federal Business Opportunities website in March said.

Doctors, nurses, pharmacists and healthcare consultants from the U.S. make up most of the healthcare professionals who use Twitter, according to research by Creation Healthcare, a London-based research and training consultancy. U.S. healthcare professionals make up 31 percent of the 75,000 worldwide total of healthcare professionals who turn to the social media site to "tweet" information about healthcare policy, research, individual medicines and treatments for the disease.

Still, social media, in general--for med device and pharma companies, as well as health payers and providers--is about actively influencing consumers, educating and empowering them to drive measurable results, according to a Deloitte University Press article published earlier this year.

 


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Erado Press's curator insight, July 8, 7:43 AM

FDA offers medical device manufacturers and pharmaceutical companies insight on how to share benefit and risk information on 23 electronics digital platforms, ranging from Twitter and blogs to online paid search programs. Specifically, it calls for a balance between risk and benefit information posted to online platforms.

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FDA Twitter guidance greeted with caution

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Examples of Mobile Apps For Which the FDA Will Exercise Enforcement Discretion

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The growing influence of social media in healthcare

The growing influence of social media in healthcare | FDA Guidance | Scoop.it

Social media has established itself as a powerful channel for voices in the NHS, whether it is to create professional networks, raise safety concerns or seek support in self-management of conditions. Participation is no longer optional, writes Claire Read

A recent episode of the BBC documentary series Business Boomers focused on the amazing growth of Amazon, tracking its development from garage-based small business to multinational giant.

It was filled with an array of interesting tidbits but arguably the most memorable was a clip from a 1994 episode ofTomorrow’s World.

In it, the earnest presenter - surrounded by a collection of very bulky and very beige computers - explained how “something called the internet” was set to revolutionise the availability of information.

It was a stark reminder of just how far digital communication has come in a short time; a reminder that is particularly important within healthcare.

Foreword to the HSJ and Nursing Times Social Media Pioneers supplementSocial Pioneers interactive graphicThe mobile friendly list of our Social Media PioneersNow you’ve signed up, the real work beginsDean Royles: The path to picking our Social Media PioneersDownload a free PDF of the supplementHealth chiefs flock to Twitter to talk to staff and the public

A digital age

Those the NHS is recruiting today - the leaders of tomorrow - will never have known a world without the internet.

Paediatric and young adult patients will fall into the same category. And soon enough we will have a generation not only of “digital natives” but of social media natives.

‘Online networks seem likely to offer solutions to many of the current communication challenges the health service is facing’

It all means healthcare practitioners and organisations are likely to have no choice but to engage with social media. It is where their patients and colleagues will expect to have conversations, and so not to be there would simply not be sustainable.

The growing influence of social media in healthcare is associated with the sustainability of the NHS in a much broader sense, however.

Online networks seem likely to offer solutions to many of the current communication challenges the health service is facing, and provide an extremely positive reason for the growing influence of social media in healthcare.

 

Take sharing concerns. In the aftermath of the Francis report, much attention has been focused on ensuring staff can speak out without fear and safe in the knowledge that their worries will be suitably investigated.

Twitter provides a simple way to encourage this sort of open environment: a nurse tweeting his or her chief executive a concern seems far more transparent than other potential methods. It is no coincidence that Twitter has provided a natural home for the Nursing Times Speaking Out Safely campaign.

Online connections

There is also frequent talk of the importance of the NHS sharing knowledge and innovation more effectively. Here too social media networks are making a tremendous difference, allowing healthcare professionals to build connections both inside and outside their own organisations.

WeNurses is a tremendous example of this, bringing together nurses from across the world in Twitter conversations. Knowledge and views are being shared, and in some instances huge and valuable professional networks being built.

Let us not fall into the trap of thinking it is only healthcare professionals who are serving to increase the influence of social media in the NHS, however.

‘Patients have been the trailblazers, making electronic connections with fellow sufferers of a condition and coming together to raise concerns about standards of treatments’

In many ways, it is patients who have been the trailblazers (as our list of Social Media Pioneersdemonstrates). They began by making electronic connections with fellow sufferers of a condition, and continued by coming together to raise concerns about the standards of treatments at particular institutions.

Surely the next step will be for those working within the health service to fully employ social media to converse with service users?

This again will address many of the communication challenges currently being placed in front of health service managers: the question of how to build openness and a genuine dialogue with patients that is based on listening.

Twenty years ago, the internet was the new development. Few could now imagine our lives without it. It seems likely that, in 20 years time, we will be saying the same thing about social media. It has already influenced the health service - but it is only just getting started

 


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Paul Deemer's curator insight, June 6, 1:41 AM

The social media movement continues to gather pace in the NHS 

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FDA issues draft guidance on appropriate use of voluntary consensus standards in medical device submissions | Lexology

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