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

Mindmap of Social Media Use by Healthcare Communities

Transcript for February 16, 2010
All times are Pacific Time

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

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

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

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

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

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

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

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

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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