FDASM Forum: Report Out – Report for the FDA on UM Health Community Use of Social Media

– Ted Hanss provided a background about OER and relayed local faculty
concerns about social media risks and accountability.
– Anuja Jain revealed concerns about professionalism and transparency
as potentially conflicting aspects of social media.
– Melissa Levine said one of the most important things I heard – to
not be afraid of contributing comments to the federal docket but to
think of it more along the lines of a marketing survey for the
government.
– Mary Kratz told wonderful stories and showed an amazing video
illustrating the power of social media use for communities and
interventions in Africa and as a support for mobile health.
– Brenda Jones talked about research from the patient point of view,
and how patients are both passionately using research in participatory
medicine, but also contributing to crowdsourcing efforts to gather
important data.
– Jessica Soulliere spoke on the concerns of the balance between too
much and too little regulation, and the importantance of individuals
who represent the institution having permissions to do so, being aware
of the institutional context and mandates before speaking, and being
aware that even as a private individual what you say may be
interpreted as representing your institution.

And from that, and the ensuing community conversation was distilled the following report for the FDA’s docket on social media.

FDASM Forum Report Out: Overview

Yesterday’s public forum on the FDASM was absolutely wonderful. I felt like a miracle was happening, and I really wished we could have recorded it for more people to see. We had 32 people, with seven presenters, each of whom spoke for slightly less than 10 minutes. A handful of the attendees were already present in social media, while most of them were interested in finding out what’s the big deal – what’s going on and why is it important.

I was asked for electronic copies of the handouts, ditto for the notes, and ditto for whatever document we end up with that assembles the pieces. Rather than send those to individuals, I’ll try to put things here so that they are accessible to a wider audience. I am hoping that some of the presenters might be willing to share their prepared remarks, and will include those in the final document if possible.

To start, here are the slides for my introduction to the issues, followed by the twitter stream for the event as made available by WTHashtag, with retweets edited out (repetitions of what one person said) and tweets on the FDASM that were not from our event.

Introduction to the FDASM: Campus Forum, February 16, 2010: http://www.slideshare.net/umhealthscienceslibraries/introduction-to-the-fdasm-campus-forum-february-16-2010

www.mindmeister.com/41914191/health-communities/

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#fdasm
wthashtag.com/fdasm
Transcript for February 16, 2010
All times are Pacific Time

* INTRO *
3:48 pm jesssoul: @jesssoul will be tweeting the #fdasm forum today from noon – 1:30 p.m. in Dow Auditorium @UMHealthSystem.
3:53 pm jesssoul: You can find some background info here: http://fdasm.com/ #fdasm
3:57 pm jesssoul: And the news release about today’s fourm: http://ow.ly/16m1N Back at noon! #fdasm
4:57 pm jesssoul: Before we begin. The FDA is specifically seeking input on five questions: #fdasm
4:58 pm jesssoul: 1) For what online communications should manufacturers, packers or distributors be accountable? #fdasm
4:58 pm jesssoul: How can manufacturers, packers or distributors fulfill regulatory requirements in their Internet and social media promotion? #fdasm
4:59 pm jesssoul: 3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties? #fdasm
4:59 pm jesssoul: 4. When is the use of links appropriate? #fdasm
5:00 pm jesssoul: 5. How should Internet adverse event reporting take place? #fdasm
5:01 pm jesssoul: We are also seeking input on additional issues/concerns the audience has. Please tag your questions, suggestions to participate w/ #fdasm
5:08 pm MLibraryHealthy: FDASM University of Michigan Campus Forum will be starting shortly http://bit.ly/b4UfTk #fdasm

* PATRICIA ANDERSON *
5:12 pm jesssoul: Patricia Anderson, emerging tech librarian explains the FDA process and development of guidelines. Pharma has been shaping the convo. #fdasm
5:13 pm jesssoul: FDA wants more patient/public input – as many voices as possible. Guidelines should empower us rather than constrain. #fdasm
5:13 pm MLibraryHealthy: Everything about the FDA, Internet and Social Media http://www.fdasm.com/ #fdasm
5:14 pm jesssoul: Looking at med products they ALREADY regulate. #fdasm
5:15 pm jesssoul: Affects broad range of communications – peer-to-peer, provider-to-patient, etc. Is personal conversation relevant? #fdasm
5:16 pm MLibraryHealthy: Patricia Anderson, UM Emerging Technologies Librarian, opening speaker for the #FDASM forum http://bit.ly/amJLYL
5:17 pm MLibraryHealthy: FDA Questions: 1.Accountability, 2.regulatory requirements best practices, 3. corrective info, 4. links, 5. adverse event reporting #fdasm
5:18 pm jesssoul: Are the previously mention 5 questions all they should be paying attention to? Are these the right topics? #fdasm
5:20 pm jesssoul: Example:article: Health Insurers Caught Paying Facebook Gamers Virtual Currency to Oppose Reform Bill – Zynga scandal. #fdasm
5:21 pm jesssoul: Article link: http://ow.ly/17UUE #fdasm
5:22 pm jesssoul: Concerns about semi-private conversations, outbound links, spurious content – who is allowed to decide who says what? #fdasm
5:23 pm MLibraryHealthy: Mindmap of social media uses by healthcare communities #fdasm http://bit.ly/aqXnY1
5:23 pm jesssoul: FDA put out internet marketing letters last year for the first time. Big companies got scared. #fdasm
5:25 pm 2healthguru: Well Done!! >> Mindmap of social media uses by healthcare communities #fdasm http://bit.ly/aqXnY1 via @MLibraryHealthy
5:25 pm MLibraryHealthy: Who can talk about offlabel use? Need to find a better way to distinguish independent journalism from mere marketing strategies. How? #fdasm
5:25 pm jesssoul: Off-label use discussions are a big issue. Bloggers talking online, licensure to speak about are at issue. #fdasm
5:27 pm jesssoul: What do YOU want the FDA to do? #fdasm
5:28 pm jesssoul: Why do we need specific guidelines and instructions in the first place? Why is this different than what we already have? #fdasm

* TED HANSS *
5:30 pm MLibraryHealthy: Ted Hanss, Director for Enabling Technologies at UMMS, second speaker at #fdasm forum http://sitemaker.umich.edu/enablingtech/about_us
5:30 pm jesssoul: “Emerging platforms for online collaboration are fundamentally changing how we work.” #fdasm
5:30 pm jesssoul: Guidelines for convos in the cafeteria don’t translate exactly to a online chat room. #fdasm
5:31 pm jesssoul: Doctor patient relationships – is it appropriate to friend patients and discuss medical information on FB? Blogging anonymously? #fdasm
5:32 pm DaveBenjamin: @jesssoul I thought HIPPA laws prevented private information becoming public? #fdasm
5:33 pm jesssoul: UMMS is working on open courseware, open medical school, use FB, Twitter, Blogs, etc. What risk are taking by putting online? #fdasm
5:33 pm jesssoul: @DaveBenjamin It should, but people’s misperceptions of privacy online may cause leaks. #fdasm
5:36 pm jesssoul: @DaveBenjamin These R discussion topics. It is unethical,decidedly, 4 physicians to friend their patients, discuss med info online. #fdasm

* ANUJA JAIN *
5:37 pm jesssoul: Anuja Jain, medical student, talks about students using social media as an outlet. We’re all young and want to have fun. #fdasm
5:37 pm jesssoul: But now, a patient you care for the next day sees you at the bar the night before drinking a few beers? #fdasm
5:37 pm jesssoul: Our lives are no longer private, and it’s all over the internet. #fdasm
5:38 pm jesssoul: We’re struggling with 1) how do you define professionalism? Med School, patients, students, physicians? #fdasm
5:39 pm MLibraryHealthy: How does social media affect the professional reputation of doctors? Seeing your Dr. in less-than-professional activities on youtube? #fdasm
5:39 pm jesssoul: 2) No way we can get away from Facebook, YouTube or Google. How do we protect ourselves? #fdasm
5:39 pm jesssoul: 3) Who are our role models? #fdasm
5:41 pm jesssoul: Talking about study using various types of status updates: Having docs, patients, students rate how professional situations are. #fdasm
5:42 pm jesssoul: Study will help create policies to address professionalism for medical students online. #fdasm

* MELISSA LEVINE *
5:44 pm jesssoul: Melissa Levine, copyright officer, U-M Library, thinks marketing needs to be more transparent. #fdasm
5:44 pm MLibraryHealthy: Melissa Levine, UM copyright officer, http://www.lib.umich.edu/copyright/ discusses intellectual property and regulating speech #fdasm
5:45 pm jesssoul: We are dealing with the issue of speech – corporate or private – and to the degree it’s going to be regulated. #fdasm
5:45 pm jesssoul: The ecosystem of $ is so complicated, and whether funding for research is going to sway his decision to rx a drug. #fdasm
5:48 pm MLibraryHealthy: An introduction to FDA Social Media Guidelines http://bit.ly/bBJmZ7 #fdasm
5:50 pm jesssoul: The federal register process is easy – you go online, look at the questions, identify yourself and answer them with examples. #fdasm
5:51 pm MLibraryHealthy: “WHO can say WHAT to WHOM WHERE online about health” http://bit.ly/dsJDK8 #fdasm

* MARY KRATZ *
5:52 pm jesssoul: Mary Kratz, senior advisor, Health Informatics discusses how fed gov uses social media. #fdasm
5:54 pm jesssoul: Kratz emphasizes need for posts that lead to conversation and transparency. Not regurge of PR. #fdasm
5:55 pm MLibraryHealthy: Mary Krantz, health informatics pres. emergency plan for AIDS relief: Partnership for an HIV Free Generation http://bit.ly/bJVsLf #fdasm
5:56 pm MLibraryHealthy: RT @jesssoul: Kratz emphasizes need for posts that lead to conversation and transparency. Not regurge of PR. #fdasm
5:58 pm jesssoul: Kratz showcases online video HIV education/prevention through pub-private partnership for HIV-free Generation #fdasm
5:58 pm jesssoul: Video: http://hivfreegeneration.warnerbros.com/ click Game, Launch Video #fdasm
5:59 pm MLibraryHealthy: Checking out the #fdasm page at @wthashtag http://wthashtag.com/fdasm

* BRENDA JONES *
6:03 pm jesssoul: Brenda Jones, managing director of the medical innovation center. Impact of SM on research from patient point-of-view. #fdasm
6:03 pm MLibraryHealthy: Brenda Jones, Managing director of Medical Innovation Center, discusses impact of social media on research http://bit.ly/cNBEz1 #fdasm
6:03 pm jesssoul: Discusses Health 2.0 conference – first launched in 2007 – crystalizes what is happening in Health 2.0 #fdasm
6:04 pm amednews: RT @2healthguru Well Done!! >> Mindmap of social media uses by healthcare communities #fdasm http://bit.ly/aqXnY1 via @MLibraryHealthy
6:04 pm jesssoul: Patients are more in control of the information they receive. Exert influence over health care and research being carried forward #fdasm
6:05 pm jesssoul: Discusses @23andme and @patientslikeme, @Curetogether. – input info to track own health. #fdasm

* JESSICA SOULIERE *
6:08 pm MLibraryHealthy: @jesssoul Jessica Souliere, Pub Relations Rep and SM communications, discussing UMHS marketing through social media #fdasm
6:10 pm MLibraryHealthy: Who will be responsible for misinformation posted by community members? How can an organization protect itself? #fdasm
6:10 pm jesssoul: These sites won’t supplant typical clinical research, but clinicians, researches and institutions need to harness rich info. #fdasm
6:11 pm jesssoul: I’ve just presented, and so now on to discussion. #fdasm

* DISCUSSION *
6:12 pm MLibraryHealthy: Please file your own comments and concerns through FDA. Comment deadline Feb 28 11:59pm ET http://bit.ly/diSmaI #fdasm
6:14 pm jesssoul: Transparency. Is there a recommended disclaimer? Disclaimers may be problematic because they may not include all possibilities. #fdasm
6:15 pm MLibraryHealthy: Q: Recommended procedures to improve transparency? Issues with disclaimers? #fdasm
6:15 pm jesssoul: Disclaim not to insulate but to disclose who you are and your association with information. #fdasm
6:17 pm jesssoul: Disclaimers don’t work for broadcast media really either. #fdasm
6:18 pm jesssoul: Information on health literacy should be tied to social media. #fdasm
6:19 pm jesssoul: Question to the audience: What would you tell the FDA? #fdasm
6:20 pm jesssoul: Map out in detail, who can say what to whom – instead determine existing categories that this already applies to ie: public speech… #fdasm
6:21 pm jesssoul: Map to type of speech to existing law. #fdasm
6:22 pm jesssoul: Can social media be put into categories of speech? Lawyers may feel we have enough laws, just new ways to implement. #fdasm
6:24 pm jesssoul: How do lay people get the info about FDASM? FDA communicated through standard docket and not in social media. #fdasm
6:24 pm jesssoul: This is a very complicated topic that the FDA did not do a good job of communicating about to the public, yet they want public info. #fdasm
6:25 pm jesssoul: The FDA is here to protect patients. They clear or approve labeling information. Make sure manufacturer is being accurate. #fdasm
6:27 pm jesssoul: Is the cell phone a med. device when a photo is taken and sent to a doctor for diagnosis? FDA draws the line at commerc. dist. svc. #fdasm
6:31 pm jesssoul: Are we talking about the snake oil salesman or health literacy? #fdasm
6:32 pm jesssoul: We are the 1st gen where something looks very official, but it’s not so line becomes blurred, health info online is a new world. #fdasm
6:33 pm jesssoul: What’s the balance between FDA and self-correcting aspects of social media? #fdasm
6:35 pm jesssoul: Don’t underestimate importance of health literacy – particularly on the internet. #fdasm
7:31 pm jesssoul: Thanks all for the good discussion. Remember, Please file comments, concerns through FDA by Feb 28 11:59pm ET http://bit.ly/diSmaI #fdasm
8:05 pm pfanderson: Back from AMAZING #fdasm forum here at #Umich. Blew my mind. Gr8 presenters, good questions. Need to blog it.

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FDASM Public Forum: Allons Dansez, Colinda!

I’ve been gearing up for this for months – our local FDASM forum. Which was utterly AMAZING, in case there was any doubt. There shouldn’t have been (doubt, that is), but a number of things had gone wrong with trying to arrange the event, so please forgive me if I was a fair bit nervous. The event had been rescheduled a few times, and it didn’t really register in my mind that the final date was, um, Mardi Gras (!!!) until I was in the hallway outside the venue. I couldn’t believe that I had mentally MISSED that it was Mardi Gras! My mother’s side of the family is Cajun, and not just Cajun but according to my sister’s research, we are actually descended from Joseph Broussard, better known as Beausoleil. THAT Beausoleil, yes, the original Cajun. Certain portions of my family take a great deal of pride in this, and Mardi Gras is a serious business for us.

What does that have to do with the FDASM, you may well ask. Just let me tell the story — I was getting to that!

So, here I am, walking down the main drag hallway in the hospital, lost in my own thoughts of Mardi Gras, singing to myself. My absolute favorite Cajun song stuck in my head from when I was a child is “Allon Dansez, Colinda“. I’ll give the lyrics at the end of the post (count yourself lucky I’m not singing this to you, which I have actually done in public, so it is a genuine risk). My super short English language paraphrase of it goes like this.

“Hey, pretty girl, let’s go dancing,
skin to skin, cheek to cheek,
like we’re glued to each other;
let’s make all the old ladies angry.
Don’t worry! Your mama’s not watching.”

I realized this is to some extent where social media is in healthcare, and pretty much in general! It’s social, it’s this grand party. A lot of people are just having the time of their life. A bunch are milling around wondering why they are there and when will the band start playing again so they don’t have to talk. Some folk are shy and don’t want to dance, others are worried who’s watching or that they’ll get in trouble. Some are there to cause trouble and take great delight in making folks angry or misleading people. Did you ever go to a party when you were young that you really didn’t want to have to explain to your parents? Maybe you still haven’t told your parents about it. (I don’t think I ever did, and it is 40 years later for me!) Some are thinking, “What can I get away with while Mama’s not watching” while others are thinking, “I can’t! What if Mama finds out?”

And this is what the FDASM is about. Mama is headed over to the party. Are we ashamed at what she might find out? Are we trying to hide before she gets there? Are we having a fine time and are grown up enough that we don’t want our parent interfering or embarrassing us? Are we worried that if someone else gets in trouble it will make trouble for us even though we didn’t do anything wrong? Or that Mama will jump to conclusions and think we did something wrong just because Mama doesn’t understand what parties are like for teens these days?

I told the folks at the event about the song. For myself, I was as proud as could be to stand on stage with that brilliant, insightful, thought-provoking crew of folk who are doing some really deep thinking about what can, could and should be done with social media as regards healthcare. I will try to share bits and pieces of the event over the next few days as I organize thoughts for the official record. For tonight, Mardi Gras night, as just a little bit of lagniappe, let me go back to Mother’s, my favorite breakfast joint in New Orleans.

Allons dansez, Colinda;
Dansez coller, Colinda;
Allons dansez, Colinda,
Pour faire fâcher ces vieux femmes.

Allons dansez, Colinda;
Dansez coller, Colinda;
Allons dansez, Colinda,
Par ta mama n’est pas là.

FDASM Podcast Now Available

Before tomorrow’s big event, I wanted to share last week’s brief presentation at the School of Dentistry on this important topic.

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

Podcast of slides with audio available at the School of Dentistry iTunesU (WARNING – clicking on the link below will launch the iTunes application on your computer, but the download is free).

http://deimos3.apple.com/WebObjects/Core.woa/Browse/umich-public.1545249956.01545249960.3339296267?i=1545573508

While you are at it, you might want to also check out the School of Dentistry Youtube channel, which was recently ranked #2 most viewed of all educational channels in YouTube. They do good stuff with online media.

http://dent.umich.edu/featured-news/engaging-the-world

Medlib’s Blog Carnival 2.1: Free Speech in Health Information, and More

WARNING: After this entry was originally posted, it came to my attention that I had not received all of the early entries for this round of the Carnival. The following post was edited to reflect these updates.

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In the context of the looming deadline for comments on the FDA’s development of social media guidelines, the Medlib’s Blog Carnival theme this month was on free speech in health information. Briefly, the FDA has a long history of managing and establishing guidelines to prevent unethical publication of inaccurate or misleading health information from persons or corporate entities promoting the use or sales of drugs or medical devices. The flip side of this is to encourage informed decisionmaking based on high quality unbiased health information. There were few submissions this month, but those received were sound contributions looking at various aspects of this complicated issue.

Laika provided not one, but TWO excellent posts. The first one, “NOT ONE RCT on Swine Flu or H1N1?! – Outrageous!,” discusses the issue of popular news and hype as opinion influencers in comparison with actual research. Taking H1N1 as an example, she begins with a Twitter post and popular press, then discusses when it is appropriate to expect what kind of evidence in support of a question, simple tips for finding better quality evidence, as well as specific scientific and clinical contextual issues that beautifully illustrate not just issues of scientific research and methodology, access to information and information quality assessment, but also quite a bit of useful information about H1N1 itself! Laika provides a strong voice for clear reason and balanced information, but at the same time respects the importance of scientific dialog and communication in shaping the evolution of what we know about any given topic.

Laika’s MedLibLog: NOT ONE RCT on Swine Flu or H1N1?! – Outrageous!. http://laikaspoetnik.wordpress.com/2009/12/16/not-one-rct-on-swine-flu-or-h1n1-outrageous/

In her second post for this Carnival, Laika again zeroes in on the issue of dialog in science, and the broader issue of respect. This is true not just for dialog between scientists, as in the example she discusses, but even more so among the public and news media. The life lessons learned by Laika in her tale of disrespect and influence among scientists are ones we should all keep in mind when observing disagreements about science. I wanted to cheer when I read her excellent, methodical review of the limits of evidence-based medicine, and when one should or should not apply its finding to a given situation. While EBM is a very useful tool, I also have encountered worrisome instances in which a useful, low-risk, low-cost intervention is not used because there are not yet sufficient RCTs or because it is being researched for XYZ use but hasn’t yet been approved for it by the FDA. When EBM becomes a barrier to good clinical care, we have a different problem. I particularly liked the example she gave of a systematic review finding insufficient evidence to support the use of parachutes when jumping from a plane, and the selection of quotations from comments. My favorite, succinct and clear, was this line from a clinician at my institution, “RCTs aren’t holy writ, they’re simply a tool for filtering out our natural human biases in judgment and causal attribution. Whether it’s necessary to use that tool depends upon the likelihood of such bias occurring.” Read, read, and read this post again.

Laika’s MedLibLog: #NotSoFunny – Ridiculing RCTs and EBM. http://laikaspoetnik.wordpress.com/2010/02/01/notsofunny-ridiculing-rcts-and-ebm/

Dr. Shock’s post about BioMedSearch focused on “free” as in free access to quality healthcare information. A related concept in his post were the barriers traditional search methods provide to discovery of quality health information, and if it is time for a change. While you are visiting his blog, you might want to take a look at another recent post on “The Hidden and Informal Curriculum During Medical Education,” which talks about overt and covert concepts and communications in medical education. While the specific example was about narratives in a secured online space, the concepts are perhaps even more important when thinking about healthcare communications in unsecured social media spaces.

Dr. Shock, A Neurostimulating Blog: BioMedical Search on BioMedSearch: http://www.shockmd.com/2009/11/28/biomedical-search-on-biomedsearch/

In an oblique connection, Novoseek, the innovative biomedical web search engine covering Medline, grants and online publications, offered a post on their new feature, allowing searchers to limit by publication type. While this doesn’t directly connect to free speech (rather the reverse) it does directly connect to quality of health information and control through peer review, both of which are implied contextual issues. Being able to use a health specific search tool automatically focuses results on a narrower and higher quality subset of the information available on the web. Being able to limit by publication type enables the searcher to slice the search even more finely, focusing on just the highest quality health information available.

Novoseek: Tip #1 to improve searches in novoseek – Filter results by publication type. http://blog.novoseek.com/index.php/resources/tip-1-to-improve-searches-in-novoseek-filter-results-by-publication-type.html/

PS. While you are taking a look at that blogpost, you might want to also take a look at an earlier post from Novoseek called The importance of context in text disambiguation. It is a kind of geeky, technical post, but the fundamental concept is central to how humans (as well as computers) identity quality when they see it.

FDASM University of Michigan Campus Forum

UPDATE: The date has been changed. Please see below for details.

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FDASM = The FDA’s process to develop guidelines for health information in social media and online spaces. I think of it as this:

WHO
can say WHAT
to WHOM
WHERE online
about health information.

EVENT
February 16, 2010, Tuesday
12 noon to 1:30pm
Dow Auditorium, Towsley Center
Directions: http://www.med.umich.edu/meded/towsley/
WikiMapia Directions: http://wikimapia.org/2163107/Towsley-Center-for-Continuing-Medical-Education

SPEAKERS
* Patricia Anderson, Emerging Technologies Librarian, Health Sciences Libraries
* Ted Hanss, Director for Enabling Technologies, UMMS
* Anuja Jain, Medical Student, Social Media Research Project, UMMS
* Brenda Jones, Managing Director, Medical Innovation Center, UMHS
* Mary Kratz, Senior Advisor, Health Informatics, President’s Emergency Plan for AIDS Relief, U.S. Naval Health Research Center & UMMS
* Melissa Levine, Copyright Officer, University Libraries
* Jessica Souliere, Senior Public Relations Representative and Social Media Communications Coordinator, UMHS
* and YOU!!!

ABSTRACT
February 16, noon-1:30 in Dow Auditorium, there will be a campus public forum on the FDA’s guidelines for health information in social media. These guidelines will influence who can say what to whom where online regarding health information. Examples of potential impact areas include communications between clinicians with peers or patients, recruitment for clinical research, promotion of research findings or clinical guidelines, and much more. Learn how you can influence the FDA in their process to develop these guidelines by sharing your thoughts, hopes and concerns with your peers here and with the FDA.

PRESS RELEASE

Feb. 4, 2010
For more information, contact:

Jessica Soulliere, jesssoul@umich.edu
734-764-2220

For immediate release
U-M hosts forum on use of social media, Internet to promote FDA-regulated medical products
Public invited to give input for recommendations to FDA

ANN ARBOR, Mich.—The University of Michigan Health System invites members of the public to attend a free community forum to discuss how industry should be allowed to use social media and the Internet to promote Food and Drug Administration-regulated medical products such as prescription drugs for humans and animals, prescription biologics and medical devices.

The event, which includes a panel of experts from UMHS, will take place from noon – 1:30 p.m. Tuesday, Feb. 16, in Dow Auditorium, Towsley Center, 1500 E. Medical Center Dr.
On Nov. 13 and 14, 2009, the FDA hosted a 15-part hearing encompassing 76 presentations entitled, “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools,” to begin gathering input from the public on how future policies in this area should be developed.

The FDA is specifically seeking input on five questions:
1. For what online communications should manufacturers, packers or distributors be accountable?
2. How can manufacturers, packers or distributors fulfill regulatory requirements in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications?
3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
4. When is the use of links appropriate? And
5. How should Internet adverse event reporting take place?

Public participation is encouraged from any interested party, including consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies and the regulated industry.

Recommendations developed during the Feb. 16 forum will be submitted to the FDA for consideration in making future policy decisions on this issue.

For a complete primer on the issue, including links to Web casts of the original hearings, industry commentary and new developments in the conversation, visit http://fdasm.com/.

Map to the Towsley Center: http://www2.med.umich.edu/healthcenters/gmaps/medcenter.cfm

MORE INFORMATION

FDASM: http://fdasm.com/

ETechLib: FDASM: http://etechlib.wordpress.com/tag/fdasm/
Event (this page): http://etechlib.wordpress.com/2010/02/01/fdasm-university-of-michigan-campus-forum/
Downloadable & embeddable copy of the poster here: http://www.slideshare.net/umhealthscienceslibraries/fdasm-event-poster-feb16

CDC in Social Media: http://www.cdc.gov/socialmedia

FDA in Social Media: http://www.fda.gov/socialmedia

FDA: About the Hearings: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm

Comments currently in the docket (Docket ID: FDA-2009-N-0441) at Regulations.gov: http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2009-N-0441

Introduction to the FDASM (slides from a presentation given in Second Life on December 13th): http://slideshare.net/umhealthscienceslibraries/introduction-to-the-fdasm

“Why not Google Earth for my Body?”

This video should be required viewing for doctors, nurses, healthcare students, healthcare consumers, patient advocates, pharma industry, librarians, IT experts (especially healthIT), health reform activists, government … need I go on? EVERYONE!

Briefly, ePatient Dave Bronkart (known as @epatientdave on Twitter) here talks about how technology, social computing, personal health data, pharma corporation websites, web searches, Google Health, Google Docs, mashups and more all contributed to his being alive and able to talk to us today, and the impact of these for the future and participatory medicine.

The Quantified Patient: http://vimeo.com/8411312

The Quantified Patient from e-Patient Dave deBronkart on Vimeo.

Social Media Policies & Issues – Two New Resources

Last August I worked on the Enterprise Social Media series, which continues more slowly, and recently I’ve been working largely on the FDASM series about new policy guideline development there. I recently stumbled on a couple resources I wanted to share with you here, and which relate to both of these main topics.

The Social Media Governance site has a LOT of things relevant to the whole Enterprise 2.0 topic. Worth exploring in general, but if you are doing either implementation or administration of any social media initiative, you MUST check out the Policy Database. This collects social media policies and guidelines from various organizations, and groups them by type of industry. Absolutely essential reading. The Healthcare section (shown here) has a collection of types of social media guidelines already being used in different places, from clinical environments to academia to insurance to pharma. It absolutely should be reviewed by anyone involved in the FDASM process.

Social Media Governance: Policy Database: http://socialmediagovernance. com/policies.php?f=4

On a related note, the whole question of the balance between transparency and privacy in social media is core to all of our lives these days. Here are two very useful taxonomies also relevant to the policy development process, and which could be applied to determining levels of privacy for different types of information and audiences in healthcare (as well as others).

Taxonomy of Social Networking and Privacy: http://www.schneier.com/blog/archives/2009/11/a_taxonomy_of_s.html
(via CIS Cyberlaw at Stanford)

Mechanical Poetry: Another Categorization of Social Networking Data: http://mechpoe.blogspot.com/2009/11/another-categorization-of-social.html

FDASM Transcripts as a Wordle Visualization

I’ve been concerned about the archived videos of the FDASM webcast disappearing this week. I’ve heard from so many people that they don’t have time to watch them, and that it is too hard to find the interesting parts in the two eight-hour chunks of video currently available. Perhaps the transcripts will be a little more accessible? It is still a thousand pages of content, but perhaps easier to skim. The transcripts can be downloaded here (bottom of the page):

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

In the meantime, here is a Wordle visualization of the most frequently repeated terms from the transcripts. Click through for higher resolution versions.

FDASM Introduction

Since this discussion has come up about how the FDA might regulate conversation within social media, I’ve been talking about it to everyone who stands still briefly. Basically, I think this is IMPORTANT.

So when I was asked to talk about FDASM in Second Life to an international group of health care consumers, educators and advocates, I said, “When? This weekend?”

There was a great discussion there, which will take me a little time to pull together, so that will come in a few days, I hope.

I figured anything I put together for them would be useful for other groups as well, so put the slides in Slideshare and here, thinking they might be useful for background in preparing for our campus forum on the FDASM the last week of January. More info on that coming soon, but in the meantime, here are the slides.