Health Care Social Media for Medical Device Manufacturers - FDA - Presentation at MassMEDIC
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Health Care Social Media in the Face of Continued FDA Regulatory Uncertainty for Medical Device Manufacturers, Presented at MassMEDIC conference 05 13 2011
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Health Care Social Media for Medical Device Manufacturers - FDA - Presentation at MassMEDIC
- 1. Health Care Social MediaIn the Face of Regulatory Uncertainty MassMEDIC May 13, 2011 David Harlow JD MPH The Harlow Group LLC blog • healthblawg.com twitter • @healthblawg
- 2. BREAKING: Pew Internet Project: The Social Life of Health Information 2011 @susannahfox e-patients.net pewinternet.org
- 3. “Why Do You Rob Banks?”Willie Sutton:“Because That’s Where the Money Is.”
- 4. Marcomm in the 21st century is radically different from the recent past
- 5. Facebook Nation is the third largest nation in the world global warming sex facebook
- 6. You can use social media effectively and stayon the right side of the law
- 7. Is social media right for health care?
- 8. The medical establishment is now getting wise to social media Monday, November 15 2010 AMA Policy: Professionalism in the Use of Social Media The Internet has created the ability for medical students and physicians to communicate and share information quickly and to reach millions of people easily. Participating in social networking and other similar Internet opportunities can support physicians’ personal expression, enable individual physicians to have a professional presence online, foster collegiality and camaraderie within the profession, provide opportunity to widely disseminate public health messages and other health communication. Social networks, blogs, and other forms of communication online also create new challenges to the patient-physician relationship. Physicians should weigh a number of considerations when maintaining a presence online: (a) Physicians should be cognizant of standards of patient privacy and confidentiality that must be maintained in all environments, including online, and must refrain from posting identifiable patient information online. (b) When using the Internet for social networking, physicians should use privacy settings to safeguard personal information and content to the extent possible, but should realize that privacy settings are not absolute and that once on the Internet, content is likely there permanently. Thus, physicians should routinely monitor their own Internet presence to ensure that the personal and professional information on their own sites and, to the extent possible, content posted about them by others, is accurate and appropriate. (c) If they interact with patients on the Internet, physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines just, as they would in any other context. (d) To maintain appropriate professional boundaries physicians should consider separating personal and professional content online. (e) When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions. If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities. (f) Physicians must recognize that actions online and content posted may negatively affect their reputations among patients and colleagues, may have consequences for their medical careers (particularly for physicians-in-training and medical students), and can undermine public trust in the medical profession.
- 9. Some day, the FDA will issue social media guidelines. Maybe.
- 10. Medical device manufacturers must plan effectively in order to communicate effectively <measure twice cut once kind of pic>
- 11. What is your target?
- 12. Influence requires trust, and trust requires engagement No shortcuts.
- 13. “On theInternet, nobody knows you’re a dog.”
- 14. So how do we do this? Charlene Li and Josh Bernoff, Groundswell: Winning in a World Transformed by Social Technologies, April 2008 Monitor, rinse & repeat 14
- 15. Authentic interaction vs. legal liability
- 16. Leadership may fear losing control of message
- 17. We need to ensure that the platforms for conversations are in place
- 18. Adopt a risk management mindset to understand risk and avoid liability
- 19. First: Understand Common Law Liability
- 20. Understand HIPAA or other potential privacy violation
- 21. Understand FDA potential concerns
- 22. Who will be judging me?
- 23. You can limit liability by clearly defining roles and responsibilities in social media policies and procedures
- 24. You must observe – religiously – all the shalts and shalt nots
- 25. Case Studies
- 26. The Case of Too Much Information
- 27. patientslikeme Health care social media beyond Facebook, Twitter, YouTube & blogs
- 28. NLRB overturns employer’s “social media gag rule”
- 29. Markets are conversations Markets are conversations MICROSITE: www.accu-chekdiabeteslink.com
- 30. Adopt a risk management mindset to understand risk and avoid liability Facebook, Twitter – With Links to Microsite Microsite links to RSS, Facebook, Twitter, YouTube
- 31. Adopt a risk management mindset to understand risk and avoid liability Contrast: Birmingham Hip, Smith&Nephew Only interactive option: “email a friend”
- 32. Walled gardens
- 33. Social contagionis a powerful marketing strategy
- 34. Health Care Social Media of the Future
- 35. Your social media strategy is ready to evolve
- 37. for contact info in an sms txt dharlow to 50500 harlowgroup.net healthblawg.com twitter.com/healthblawg david@harlowgroup.net Thank You David Harlow JD MPH The Harlow Group LLC
Editor's Notes
- 1 in 4 internet users have:watched an online video about healthtracked their weight, diet, exercise routine or other health indicator onlineconsulted online reviews of drugs or medical treatments (but very few post such reviews)The survey finds that, of the 74% of adults who use the internet:80% of internet users have looked online for information about any of 15 health topics such as a specific disease or treatment. This translates to 59% of all adults.34% of internet users, or 25% of adults, have read someone else’s commentary or experience about health or medical issues on an online news group, website, or blog.25% of internet users, or 19% of adults, have watched an online video about health or medical issues.24% of internet users, or 18% of adults, have consulted online reviews of particular drugs or medical treatments.18% of internet users, or 13% of adults, have gone online to find others who might have health concerns similar to theirs.16% of internet users, or 12% of adults, have consulted online rankings or reviews of doctors or other providers.15% of internet users, or 11% of adults, have consulted online rankings or reviews of hospitals or other medical facilities.Of those who use social network sites (62% of adult internet users, or 46% of all adults):23% of social network site users, or 11% of adults, have followed their friends’ personal health experiences or updates on the site.17% of social network site users, or 8% of adults, have used social networking sites to remember or memorialize other people who suffered from a certain health condition.15% of social network site users, or 7% of adults, have gotten any health information on the sites.
- Why go on the internet – because where the people are
- .. Or at least from the past that we know. Thru most of human history:We’ve shared info thru Word of Mouth19th-20th C. – Mass Media – Now On the waneHyperlocal, or hyperspecialized … & socialized – back to WOM
- What are we going to do today? Learn some do’s and don’tsThink of social media as a power toolIf you don’t know how to use the tool properly, you could get hurt
- How?You need to think clearly about your goalsYou need to figure out – very concretely – what you’re going to do to achieve those goalsYou need to focus on your goals and staying out of troubleThis requires advance planning
- Yes! Why? Bcs: 2/3 of ppl look online for health infoOver ½ of ppl expect to get info fr HCPs on HC products & services, expect that HCPs will help the lead healthier lives===People are flocking online to find and share health information using a variety of tools, as illustrated by Brian Solis’ Conversation PrismWhat are they doing on line?2009 Pew research study - 61% of adults in the U.S. look on line for health information (66% in 2010)Runaway leader – ahead of health care professional, family, friends, print and broadcast media52% of all searches are on behalf of someone else42% of all adults say they or someone they know has been helped by health information found on the internet (up from 25% in 2006)Edelman Health engagement barometer 2010:56% expect health care providers to educate the public on health topics (products or services)53% expect health care providers to help employees and their families to lead healthier lives52% expect health care providers to support the health of local communities
- In late 2010 -- The AMA adopted a “professionalism in the use of social media” policy that is refreshingly commonsensical for the most part.Most elements of the policy are commonsensical, and represent the extension of existing norms into the social media space:Don't post identifiable patient information online.Safeguard physician personal privacy online, understanding that anything posted may remain online indefinitely.Consider separating personal and professional profiles on line.*"What happens in Vegas doesn't stay in Vegas," or, Don't post material that may reflect poorly on the profession.At least one portion of the policy, though, could potentially impose significant obligations on individual physicians active in social media:When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions. If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities.
- Listening session 18 mos ago, no sign of rules, recent announcement of study, 60 day comment pd, then who knows how long to conduct studies – and they’re very technology-specific in their design, so the information gleaned will not be very generalizable. http://j.mp/FDAstudy0411 Meanwhile FDA is ruling by warning letter ….
- This Old House: Measure Twice, Cut Once
- Docs? Leading Docs? Patients? Key influencers? Bloggers? Need to adjust tactics accordingly. Different rules apply depending on the target audience.
- On the Internet, nobody knows you’re a dog. This cartoon is almost 20 yrs old and reflects an internet ethos of an earlier timeAnonymityToday - flamers &trolls aside - There is a decided preference for owning one’s online presence.. Particularly in the realm of SoMeThere are some anonymous bloggers, but for the most part, since authenticity is the name of the game, anonymity is out.
- Sounds great, but …By developing the right consensus docuemnt, within the broader rules we have to live with, you can enable authentice interaction.Air force flow chart of policy on commenting on blog post …..There’s always the question of legal laibilityHCPs want authentic interactions with patients and prospectivce patents – who wouldn’t??Just need to go about it carfefully
- In addition to privacy and other regulatoy concerns, social media, is of course open to criticism by traditional managers – even in less regulated industiries -- as being too open – folks live in fear of losing control of the message … but as we know, you have already lost control of your message.
- Hardware, software, human capital, Policies and prrocedures developed thru an inclusive process(not just execs – incl SoMe users throguhgout org – folks who are excited about this stuff, and who can help communicate the rules informally once they’re adopted)
- Sharpen your pencils, folks, put on the green eyeshade, and put yourself in the shoes of the most risk-averse folks you know within your organizations.Need to internalize that perspective in order to be able to identify , avoid and manage risks
- A duty that one party has to another partyA breach of that dutyHarm to the second partyCausal link between the breach of the duty and the harmExample: A physician has a duty to provide services according to a standard of care; if she provides lesser services and her patient is injured as a result, that’s malpractice
- A patient can release his or her own private information, protected health information, but nobody else can w/o consentIf you violate the letter of the law (or regulation), and disclose or use information in ways you should not . . . you are liable to the federal governmentFinesState AGs can file suit under HITECH ActUnder state law there may be liability to patients as well for violating confidentialityAnd remember, patient claims that go to court will be heard by a jury
- Regulatory and compliance safeguardsSuccessful communities must embody organizational standards for handling HIPAA, off-label, adverse event, intellectual property rights, information security, and more – FDA sanctions can include fines and more.
- Patients and potential patientsReferral sourcesRegulatory bodiesA jury of your peers?Think about what policies and procedures you want to have on the books and fully implemented before you end up on trial in front of a jury made up entirely of twentysomething Facebook users who expect everyone to live their lives online 24/7
- Patient consent where relevantNotice of Privacy Practices (HIPAA NPP) should address social mediaHow it is usedDegree of privacy that may be expectedExpress notice not to use for emergencies; statement that channel is not monitored 24/7NPP and internal P&P should be consistentRemember: the fact that a patient-provider relationship exists is itself PHIEmployee training – clinical and non-clinicalGood judgmentDo not practice medicine on line . . .Unless the patient has given informed consent in advance (and even with consent, clinical interactions should not be in a public forum)Emergency exceptions? Similar to what we would do “IRL”Do not try to establish clinician-patient relationship online . . .Unless through a secure, private portal Clinician-patient communication should end up in HERRegulatory and compliance safeguardsSuccessful communities must embody organizational standards for handling HIPAA, off-label, adverse event, intellectual property rights, information security, and moreHave an established pathway for regulatory review of text of ads, etc., so that you have green-yellow-red zones identified. This will reduce the time it takes to get creative material out the door and on the web
- Therefore . . .Must clearly define the roles and responsibilities of different groups: HCPs company reps, patients; “official” tweeters; social media usersTerms of ServicePolicies and Procedures Must be tailored to your organizationMust stay within the bounds of that relationshipShaltsShalt Nots
- There are many informative examples of social media use gone awry in health care. Let’s look at a few and examine what went wrong – or – in some cases - what went right.
- In the end, these cases are all about too much information – No matter what the platform, there will always be some folks who want to use it, and those who don’t – HCP examples: pol in on a Sunday, clinic staffed up, staffer fired for tweet.PHI – RI doc on FB – anonymous but still identifiable based on other public informationFlea – The doc who liveblogged his own malpractice trial a while back …Ppl posting photos fr ED on Fcbk w/ OTHER ppl in background“I’m CA-free 1 yr later” (on FB, website)
- PLM: Nielsen scraping botAnti—terms of serrvice so easy for plm to ban Nielsen botEvent highlighted for some the fact that PLM does what Nielsen was trying to do ….Could’ve been a disaster if plm hadn’t been prepared with relevant material in its PnPGrpn, 4sq – own issues ….. Short form, fair balance, couponing???
- Once in a while – the rules require MORE social media, not less ….Case in point – American Medical Response of Connecticut, Inc. and International Brotherhood of Teamsters, Local 443, Case No. 34-CA-12576 (NRLB - Region 34), involves a complaint filed against American Medical Response for firing an emergency medical technician for among other things violating the company's policy of negatively depicting the company on Facebook or other social media sites. American Medical Response had denied the labor board's allegations and claims that the employee was discharged on various other grounds. The complaint contains the full language of the employer social media policies involved in the matter.For those unfamiliar with the National Labor Relations Act, "protected concerted activity" is an employee right under the National Labor Relations Act that protects employees from employer retaliation for discussing working conditions. The National Labor Relations Act provides employees the right to associate together to improve working conditions, self organize, assist labor organizations and bargain collectively. The Act applies to activities by union and non-union employees.
- The Cluetrain ManifestoBlogger summitsFacebook content – tips, interviews, videos – not about the device, about the condition and living with it
- Some companies, using CRM tools and a plugged-in slaes force can quantifth e value, the ever-elusive ROI on a presence like this. For an AED mfr … [Cardiac Science] SoMe generated leads, almost 1/3 closed sales w/in 15 mos, generated $2-2.5m For a co. like Roche, likely talking much, much more.
- Doesn’t cut it
- Alt to DTC approach … inviting docs to the party, or paying to eavesdrop. PhRMA does this, MedDevice can too. – many of the issues present in DTC advertising go away …
- Nicholas Christakis – “Connected” – MIT – now a startup co. -- talk to the nodes in the network. They’ll help you hit your targets faster, better, cheaper … different approach to social networking – can be online, can be in rela life … important to thinkabout both at the same time … since of course online social networking ultimatleydsdoesn’;t mean much in this business unless you take it offline, into the real world
- On the health care provider side … We’re getting to the point where there are more & more external reasons to engage in health care social mediaPatient Engagement and Patient-centered care are part of the ACO statuteCan build something like Virgin Health Miles – health promotion , incentives, teams, wewigh loss diet exercise, all opt-Iin w disclosuresSimilarly On the device side … think about what kinds of conversations you want to create, and with whom
- It’s a journey, not a destinationPolicies and procedures will be revisited and revised As you gain experienceAs your comfort level increasesAs technologies and their uses evolve
- To sum up –You can join the vanguard by being smart:Plan what you want to do, understand why you’re doing it, and write the policies and procedures up front You can stay on the right side of the lawStick to your guns –Respect the lawRespect your constituenciesRespect the power of the tools you useThink about the framework and the case studies we’ve looked at todayPlan for the future – changes are coming, and it’s better to be ahead of the curve than to play catch-up
- happy to entertain questions if we have some time-- Be careful out there … TY