Tag Archives: social media

Concerns & Clarification on the FDA Guidelines for Social Media (#FDAsm)

FDASM: FDA on Social Media

Last Tuesday afternoon, there was a Twitter chat on the new FDA guidance on social media that was hosted by the medical librarians group (#MedLibs), but which engaged an audience that also included healthcare professionals, lawyers, and communication specialists. It was a very interesting chat that touched on concerns, assumptions, misunderstandings, clarifications, and resources. You will find many of these excerpted from the full conversation and highlighted below. First, though, here is a high level summary.

Concerns included the potentail for a “chilling effect” that might impact on education, innovation, professional and patient public communications, research and clinical trial recruitment; responsibility (who is responsible for what/when/where/how with respect to health social media communications); effectiveness of social media controls for their intended purposes and the costs/benefit assessments; the role of identity, honesty, and transparency in health social media communication; and whether the guidelines will promote inclusion or foster exclusion of relevant voices in useful conversations.

Clarifications sought: plain language summaries of the guidelines; description of the potential and expected impacts on various communities of practice, including health education and patients; the relationship and responsibilities of employers and employees in their social media identity management and communications; and the issue off-label use conversations outside of pharma entities.

Clarifications which appeared during the chat (but which are note from the FDA, and therefore not the authoritative word with respect to these issues): who is covered by the guidance; community and individual efforts to create plain language distillations of the guidance; context; and a reminder that freedom of speech does not equal freedom of consequences for that speech.

For Medical Librarians: role for medical librarians in supporting and demonstrating best practices in Twitter chats; role for medical librarians in supporting education around the FDA’s guidance for their institutions as well as for patients and the public; and a caution about medical librarians being potentially excluded from social media as part institutional image controls as well as potentially as an impact of the guidance.

Takeaways: how to format an FDA-style tweet; avoid creating branded accounts for free conversation; encourage individuals to create personal accounts that are not branded and are distinct from the brand; consider correction of health misinformation as an opportunity; avoid perception of “practicing medicine” on social media, but discussions are alright; consider commenting on the FDA draft guidelines before September 17.

In addition, the conversation included discussion of best practices for identifying tweets as representing personal opinion, as well as a rich collection of resources.

CONCERNS

CLARIFICATION NEEDED

CLARIFICATION RECEIVED

FOR MEDICAL LIBRARIANS

TAKEAWAYS

FURTHER QUESTIONS

RESOURCES

FDA On Social Media: Time to Pay Attention, Take Two

FDASM Campus Forum Feb 16SL: Virtual Ability: Introduction to the FDASM
FDASM Transcripts Wordle23andMe, reduced

Remember five or so years ago when we put together a campus event about the FDA call for input on social media guidance? I blogged about it a lot. I’m sure many of you are already aware of the new FDA Social Media draft guidelines that were, at long last, released last month.

Recently I heard an interview with David Harlow about the new draft guidelines. I was very surprised when I heard him say that the FDA sent a warning letter to a company for clicking “like” on a patient’s Facebook post. That seemed a bit over the top to me, although I confess I haven’t yet found the original warning letter. I had been inclined to just trust that after thinking about this so long, the FDA would come out with something helpful, but it sounds like that isn’t what happened. Responses from the drug companies seem to be along the lines of just avoiding the whole problem, if the FDA is going to be so challenging and confrontational. Responses from folk working actively in HCSM are that the FDA is not getting the point or purpose of social media engagement, and that the guidelines are sufficiently restrictive as to make it impossible to adhere to the specifications.

I know that I need to know more about this, and I believe that readers of this blog do also. The period for public comment is over in September, so there is very little time to respond. My fault — I should have paid closer attention to this sooner.

BACKGROUND

For context, I’d like to first remind people of the comments we filed with the FDA during the original call for comments. Where it sounds like things have broken down is with respect to our third point (#3): “the potential to be perceived as interfering with free speech of the public or creating an undue and insupportable burden for industry and the healthcare communities,” and to the concerns about use of social media within an educational framework.


FDA-2009-N-0441 Docket Comments, University of Michigan Public Forum: http://www.slideshare.net/umhealthscienceslibraries/fda2009n0441-docket-comments-university-of-michigan-public-forum

Here are my slides from five years ago, just to provide context for the background of the conversation.


FDA Social Media Guidelines – Introduction http://www.slideshare.net/umhealthscienceslibraries/fda-social-media-guidelines-introduction

Now, here are some links about where things stand today, plus the presentation by David Harlow, which I encourage you to watch.

DAVID HARLOW


FDA Social Media Changes that May Affect Healthcare https://www.youtube.com/watch?v=aEutmz0kFsM

#FDAsm – FDA Releases Draft Social Media Guidance Five Years After Public Hearing http://www.healthblawg.com/2014/06/fdasm-fda-releases-draft-social-media-guidance-five-years-after-public-hearing.html

FDA Social Media Guidance – Hangout on Air http://www.healthblawg.com/2014/07/fda-social-media-guidance-hangout-on-air.html

PUBLIC HEARINGS

2009: Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htm

July 10, 2014: Social Media Guidance Webinar – July 10, 2014: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm403810.htm

FDA ANNOUNCEMENT

FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-issues-draft-guidances-for-industry-on-social-media-and-internet-communications-about-medical-products-designed-with-patients-in-mind/

Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability http://www.gpo.gov/fdsys/pkg/FR-2014-06-18/html/2014-14221.htm

NOTE: This is where to file comments >>
[Docket No. FDA-2014-D-0447] Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability https://www.federalregister.gov/articles/2014/06/18/2014-14221/draft-guidance-for-industry-on-internetsocial-media-platforms-correcting-independent-third-party

DRAFT GUIDELINES

Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf

Guidance for Industry : Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401079.pdf

Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Jan 2014) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf

Pubmed is LIVE on Social Media – Hashtags of the Week (HOTW): (Week of July 21, 2014)

Pubmed Social Media Icons
PubMed Update: Social Media Icons Added. NLM Tech Bull. 2014 Jul-Aug;(399):b2. http://www.nlm.nih.gov/pubs/techbull/ja14/brief/ja14_pm_social_media_icons.html

Have you been straddling the fence deciding whether or not social media is “a thing” in healthcare? Well, maybe this will tip the balance. Pubmed now includes social media sharing icons at the article level, as shown in the image above. This is in addition to NIH’s own active life on social media. Unfortunately, when I was testing it out, every now and then what it shared was not the link to the article, but a link to the search strategy from which I found the articles. Hopefully, they’ll get that fixed, but usually it was good. Here’s what it looks like when sharing something to Twitter.

Pubmed Social Media Sharing Example: Twitter

In honor of this noteworthy change, I thought I’d divert from actual hashtags to seeing what people are sharing from Pubmed this week. If you really want hashtags, take a look at what hashtags they are ADDING to the posts, since Pubmed doesn’t automatically add any.


First posted at THL Blog: http://thlibrary.wordpress.com/2014/07/21/pubmed-is-live-on-social-media-hashtags-of-the-week-hotw-week-of-july-21-2014/

20 Ways to Reuse Repository Content (Infographic of the Week)

20 ways to reuse repository content
Image source: Ayre, Lucy and Madjarevic, Natalia (2014) 20 ways to reuse repository content. In: Open Repositories 2014, 9-13 June 2014, Helsinki, Finland.

Last week, I was pleasantly surprised to find an infographic within a research article. This week is less surprising, but still a very practical application of infographics — a research poster! I can absolutely see using this idea myself, and actually saw a number of infographic/posters at a recent convention. The take home lesson from that is that infographic design and best practices are becoming a core competency for academics of all stripes.

This particular infographic struck my fancy because it provides interesting insights into ideas and strategies for maximising the impact of academic products. Create your research article and deposit a copy with the local institutional repository (which is, here, Deep Blue).

Deep Blue, 2014

Then you are done, and on to the next project. Right? Or not. One thing I’ve learned is that talk to a researcher around campus and most of them have a story about their favorite project that never got the attention they think it warranted. This infographic is chock full of ideas for what to do about that. Placing a copy in the repository is only the beginning.

#Kellergate — Hashtags of the Week (HOTW): (Week of January 20, 2014)

The Beginning of Kellergate

If you were busy last week, you might have missed what has become known as “Kellergate.” It erupted with an article in the Guardian by Emma Gilbey Keller, which was shortly followed by a companion piece in the New York Times by her husband, Bill Keller. Both pieces were about about famed breast cancer blogger Lisa Adams.

Emma tweeted about her post right away, and Lisa replied quickly. As of today, there are 40 replies to that initial tweet, and it is enlightening to click through and read through the initial dialog.

Keller, Emma G. Forget funeral selfies. What are the ethics of tweeting a terminal illness? The Guardian Wednesday 8 January 2014 13.40 EST. Original link: http://www.theguardian.com/commentisfree/2014/jan/08/lisa-adams-tweeting-cancer-ethics Archive link: https://web.archive.org/web/20140109033020/http://www.theguardian.com/commentisfree/2014/jan/08/lisa-adams-tweeting-cancer-ethics

Bill Keller also tweeted out when he published his piece on Lisa Adams, a tweet which has 39 replies at the time of writing this, again with many upset responses.

Keller, Bill. Heroic Measures. Op-Ed. New York Times JAN. 12, 2014. http://www.nytimes.com/2014/01/13/opinion/keller-heroic-measures.html

What both Kellers seemed to not understand is the role of patient communities in social media, and that the breast cancer community is one of the largest, most active, and most passionate of Twitter patient communities. Both posts were perceived as an attack on Lisa (justifiably), and the community reacted. The authors, at least Emma, seemed genuinely surprised.

Now, you know something is really controversial when ‘comedians’ start to pick up on it. And then when people start to make parodies of other replies!

I’ve just come from a phenomenal presentation given by Phyllis Meadows for Martin Luther King Day celebrations here at the University of Michigan. Much of what she was saying reverberated in my head, echoing aspects of what I’ve been hearing in the many conversations about Kellergate. For starters, Phyllis Meadows (a researcher on public health in communities) said earlier today, “Sometimes our intent and our impact are very different.” Clearly, this is the case with Kellergate. I’d like to frame some of this post in the context of Dr. Meadows’ MLK Day presentation. [Please note, I am working from my notes of the presentation, not a transcription or recording, so may have inaccuracies in my quotations.]

The extremely abbreviated background on Kellergate is that two journalists wrote public pieces commenting on intimate details of the life of a cancer patient (Lisa) who has chosen to share much of her life online. The first journalist (Emma) has since admitted that the article included excerpts from content that was shared with her through private modes (direct messages and email) without either notifying Lisa nor requesting permission to share them. The second journalist (Bill) had several errors of fact in his piece resulting from inadequate research, including such easily discoverable bits as the number of Lisa’s children, which is stated on her homepage. The first was a clear breach of professional ethics, and the second creates questions about professional practice, but both have actually become almost a red herring in the larger context of the conversation, which focuses on community, context, communication, caring, compassion, and comprehension (ie. listening).

Dr. Meadows emphasized the role of elitism in creating health disparities and creating barriers to finding solutions relevant to the community.

“Who speaks.
Who listens.
Who is expected to listen.
Who is responsible.
Who is blamed.
Who makes decisions.”

Clearly, both of the journalists and their parent publications were expecting to speak, and be listened to, but were not expecting to have so very many people talk back. Commentary on the posts includes both those who criticize the Kellers and those who support them …

… , although the former seem to FAR outweigh the latter.

Kellergate Responses

The phrase / hashtag #Kellergate emerged after the second essay was published.

At this point in time, there are literally HUNDREDS of responses to Kellergate, both within the official media as well as in the blogosphere, and several thousands more if you count tweets. Phyllis Meadows, in the question and answer portion of her MLK Day talk, commented, “Most people don’t know how to talk to each other. Discourse begins by seeking clarity, asking WHY you ask that question, rather than answering based on assumptions from my mental model.”

The Keller pieces both struck a raw nerve. I don’t know if the New York Times or the Guardian are interested in healing the breach that this has created between them and the large breast cancer social media community, but if they are, perhaps they might want to create an open honest space for continued dialog around this topic. I am delighted to see the POWER of the #BCSM community, and delighted that the world can now witness that power, but I am hoping that the conversation doesn’t detour into blaming on both sides and a repetitive recreation of the injury, but rather serves as a springboard for healing. Let the journalists learn more about our communities and how to communicate with them. Let the questions they were trying to raise become a healthy honest part of the social media communities and their conversations.


First posted at the THL Blog: http://thlibrary.wordpress.com/2014/01/20/kellergate-hashtags-of-the-week-hotw-week-of-january-20-2014/

“How Many Hives?”: Social Media Can Prevent a Crisis with Storytelling, Engagement, & Training

Michigan RenFest 2010

This post is about food allergies and communication strategies. But let’s step back a bit and see how I got here.

Yesterday morning early (for me, but not for most docs), I attended the local Pediatrics Grand Rounds with presenter Joyce Lee. Joyce was talking on Twitter uses for clinicians and researchers. That will be another blogpost, once I have a chance to work through some of the content presented. For today, I wanted to highlight one particular bit that Joyce presented about kids with food allergies. I had somehow previously missed this, and it is too good to miss! I am particularly interested in this since both my son and I also have food allergies.

Joyce is a pediatrician (I’m oversimplifying), and a mom of kids with pretty severe food allergies. She’s also very engaged in new technologies and is interested in new learning modalities and social media. That gives a bit of context for how she and her son came up with these phenomenal and effective ways for him to both learn and communicate what he needs to have for health care crisis prevention and support from the people around him. Frankly, from what I’m seeing here, he is MUCH better at being aware of his needs and communicating them than I am. This is also a very cool idea that I wish I had thought of when my kid was in need of this. I have a lot to learn here, and this strategy would have prevented a whole boatload of problems & events for our family over several years. This is GENIUS, pure and simple.

Joyce’s son, “B,” has severe food allergies. Note that they use a letter “B” instead of his name? This is to protect his privacy on social media. This is a good best practice, and one the kids should learn and adopt as well as the parents and teachers. And family friends, and pastors, and acquaintances, and … EVERYONE! Please, DON’T use a kid’s real name online!

The problem with food allergies, which I’ve faced, is at school other kids and teachers don’t understand and can inadvertently poison the poor kid. I remember how I wept with anger and frustration when I discovered that the school therapist my son was seeing was rewarding him for good behavior with foods that triggered undesirable behavior, and then sending him back into the mainstream classroom. I bet his main teacher wasn’t too happy either, and Lord alone knows how much school he missed from the migraines triggered by the dangerous foods. For B, a mistake like that could kill him.

PART ONE

So now, Joyce’s son has a blog.

I Have Food Allergies
I Have Food Allergies:
http://ihavefoodallergies.tumblr.com/

On his blog, he has his Youtube videos. This is the storytelling part of the post. Part One describes how to tell if he’s having a reaction, and what to do. Part Two describes how to avoid poisoning him, since it isn’t always obvious (as I am STILL learning, with my own food sensitivities). Here is the first video. When she showed this in Grand Rounds, the entire room full of doctors and nurses and other hospital staff were ooohing and aaahing and laughing. It is a very charming and effective way to deliver this lifesaving content. That’s the training part.


Allergy Action Plan (Antihistamine versus Epipen) http://www.youtube.com/watch?v=6Ymah1199xo

Joyce wrote a separate blogpost that explained the background, mechanics, theory, and how this was made.

Online Peer to Peer Education or shall we call it Peer to Teacher Education?
http://joycelee.tumblr.com/post/31910454867/online-peer-to-peer-education-or-shall-we-call-it

This is pretty cool stuff. Even more cool, the school decided to show the video to all of the kids in the school, 700 of them, and all the teachers. That’s the engagement part. Even more engagement, a blogpost by Wendy Sue Swanson (a.k.a. Seattle Mama Doc) brought more attention to this. Would this video help others understand food allergies? Does this training from this one young boy extrapolate to other kids and families?

Bring Paperwork To Life: Food Allergies:
http://seattlemamadoc.seattlechildrens.org/bring-paperwork-to-life-food-allergies/

PART TWO

Now, for comparison, let’s take a look at what a food allergy action plan normally looks like.

Food Allergy Action Plan
Food Allergy Research & Education (FARE) (www.FoodAllergy.Org): Food Allergy and Anaphylaxis Emergency Care Plan: http://www.foodallergy.org/document.doc?id=234

I’ll tell you, this is vastly more attractive, clear, and engaging than what they had when my now-college-age son was in school. Still, despite the vast improvements, it is a little scary to read through, especially if you are the one responsible for saving the life of someone else’s kid. It gives you the information, but it doesn’t make you laugh, or hear the kid’s voice when they describe how it feels for them when things go wrong.

The second video is my favorite. Less dire, but it covers all the information I need so desperately to communicate to my colleagues, restaurants, and friends. How do you not poison me? Wash the table, wash your hands, be wary of tricky foods. I especially love the part about tricky foods.


Allergy Action Plan, Part 2 (Please don’t poison me) http://www.youtube.com/watch?v=EGG6_EuK3oM

I wish so much I could make every restaurant employee in the country watch this video. And have it translated into other languages. My family spends a lot of time embedded in Japanese cultural activities, which includes Japanese restaurants. My main problem is with gluten, and you’d think I’d be safe there since their cuisine is based heavily on rice. You’d have trouble believing some of the bizarre experiences I’ve had in Japanese restaurants because of the language barrier — servers who bring me the gluten-free soy sauce, and then bring my food already doused with regular soy sauce. Oh, miso? Yes, it has wheat in it. (After I’ve eaten it and my mouth is tingling and swelling.) So why did you bring it to me? [Imagine a cranky face. More than cranky.]

Here Joyce explains more of the outcomes from the first video and considers aspect that might explain why it has proved so effective.

Allergy Action Plan Part 2: http://joycelee.tumblr.com/post/36728442953/allergy-action-plan-part-2-its-been-a-while-since

PART THREE

Did they stop there? Of course not!

One of the challenges of food allergies is that despite massive fine-tuning of your lifestyle, education of others, and so forth, there is no point at which you are completely safe, no point at which you can stop being aware, when you can rest and relax and trust that you are safe. But all of us have times when we’re tired, worn out, just not on top of our game, and must trust others to watch out for us when we aren’t quite doing such a great job ourselves. Something always happens. It is just when you get to the point of feeling safe, let down your guard, and that’s when it happens.

The videos are awesome and amazing, but what about when you aren’t online, when the class is outside or on a field trip? Joyce and B have made nametags, bookbag lists, and collaborated on making a booklet with his information. Kind of a quick reference as a backup for the content in the videos. Even better, they’ve made the original files available free online for other families and parents to use.

DESIGNING FOR HEALTH: A PEDIATRIC PROTOTYPE FOCUSED ON ALLERGIES http://joycelee.tumblr.com/post/50507408498/designing-for-health-a-pediatric-prototype-focused-on

Check out the blogpost for the other file links, but here is the PDF of the insides of the booklet.

Allergy Booklet: https://dl.dropboxusercontent.com/u/1112237/nametag/allergy%20booklet_51213.pdf

MORE

Joyce is not the only parent using social media to get out their story about food allergies, trying to get people to understand what it’s like. The more people understand, the safer life will be for those of us with food allergies and sensitivities. Here is another post from Seattle Mama Doc to round out the information in the post, and provide more context. These aren’t part of Joyce’s official story, but I bet she’s familiar with this stories. I know I am.

Four Hours on a School Bus: http://seattlemamadoc.seattlechildrens.org/four-hours-on-a-school-bus/

Here is a little more information. The basics, all in one small tidy package, and a couple useful links to learn more.

Don’t Be Shy About Food Allergies http://seattlemamadoc.seattlechildrens.org/dont-be-shy-about-food-allergies/

Food Allergy Research and Education (FARE): http://www.foodallergy.org/

Kids with Food Allergies: http://community.kidswithfoodallergies.org/pages/community

#CoolToys: Lifestreaming

Today’s Cool Toys Conversations group met to learn more about lifestreaming (not livestreaming, as some attendees thought). Britain Woodman was our fearless leader for the day, and folk were encouraged to also look at how Shawn Sieg lives the lifestreaming life. Here are a few highlights from the meeting.

What’s Lifestreaming?

“A lifestream is a time-ordered stream of documents that functions as a diary of your electronic life; every document you create and every document other people send you is stored in your lifestream.”
The Yale Lifestreams Project Page, Circa 1996: http://cs-www.cs.yale.edu/homes/freeman/lifestreams.html

Why Lifestream?

Other reasons discussed included adding value for others, transparency, making yourself and your personal brand more discoverable, ease of discovery for others as well as for yourself, as an external memory aid, simplifying your content production, searchability, safety (crime prevention), and more. One motivator for some is to connect various information streams to discover new insights, especially in the context of quantified-self and self-tracking for health. MakeUseOf posted about incentives that drive lifestreaming. There was an interesting conversation around Robert Scoble’s post on this back in 2009, but evidently the original post has disappeared or moved with the loss of Posterous.

The new billion-dollar opportunity: real-time-web curation. (Read the comments on this). http://friendfeed.com/scobleizer/db61f306/new-billion-dollar-opportunity-real-time-web

What is StoryTlr?

StoryTlr

Storytlr is a very useful tool for aggregating and (partially) archiving your own content from various cloud-based services and social media streams into a personal space on your own server. It primarily archives the text in an SQL database format, with thumbnails for images, and links to the full images and videos. It does not archive the full images or videos. It also facilitates creating stories from your various media around a particular event or day. Storytlr is open source, with the source code on GitHub.

“You can import from 18 popular sources, easily post your own updates, pick from a range of styles and create compelling stories from your content.”

What if I don’t have my own server?

More Info About Lifestreaming & Lifelogging

Lifeloggers from Memoto on Vimeo.

Lifestream Blog: Lifelogging: Resources: http://lifestreamblog.com/lifelogging/

THEN

Lifelogging, An Inevitability (2007): http://www.kk.org/thetechnium/archives/2007/02/lifelogging_an.php

Karapanos, Evangelos, PhD. Blog http://www.ekarapanos.com/blog.html
[NOTE: Fascinating entries such as "Supporting Diary Studies with Lifelogging" and "Lifelogging tools for patients suffering episodic memory impairment."]

Krynsky, Mark. Understanding the Value of Lifestreaming (2009): http://lifestreamblog.com/understanding-the-value-of-lifestreaming/

Stanford Students Design for Lifelogging (2011): http://quantifiedself.com/2011/03/stanford-students-design-for-lifelogging/

NOW

How Lifelogging is Transforming the Way We Remember, Track Our Lives (2013) http://www.wired.com/insights/2013/06/how-lifelogging-is-transforming-the-way-we-remember-track-our-lives/

I always feel like somebody’s watching me: The effect of wearable cameras (2013): http://connect.dpreview.com/post/8900204429/wearable-camera-affect

‘Life logging’ app Saga lets you share every single moment of your life (2013): http://venturebeat.com/2013/07/30/life-logging-app-saga-lets-you-share-every-single-moment-of-your-life/

Logging our lives with wearable tech (2013): http://www.deccanherald.com/content/339162/logging-our-lives-wearable-tech.html

Using a Smartphone’s Eyes and Ears to Log Your Every Move | MIT Technology Review (2013) http://www.technologyreview.com/news/516566/using-a-smartphones-eyes-and-ears-to-log-your-every-move/