DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

Social Guiding Principles Summit Opening Presentation by Joe Farris and Mark Bard
February 6, 2012 New York, NY

The following discussion took place on February 6, 2012 at the Digital Health Coalition Summit in New York, NY. Thank you to the team at ePharma Summit for partnering with us for this event and making the event, conversation, and subsequent innovations possible. The Digital Health Coalition, a nonprofit organization with 501(c)(3) status, was created to serve as the collective public voice and national public forum for the discussion of the current and future issues relevant to digital and electronic marketing of healthcare products and services.

DISCLAIMER The comments and opinions expressed in this document are the comments and opinions of the individuals and do not reflect or imply an official endorsement from any company, brand, or employer.

Copyright 2012 | Digital Health Coalition | All Rights Reserved

DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

JOE FARRIS:

I would like to welcome everyone to the Digital Health Coalitions Social Guiding Principle Summit. We have an action packed agenda for you this afternoon. Were going to go through the Social Meeting Guiding Principles that we just released today. You can keep up with the project and the DHC on Facebook and on Twitter @digitalhealthco as well. So feel free to tweet or re-tweet anything youve heard today. So before I turn it over to Mark, I just wanted to reiterate a few things. I think everybody in here is familiar with our mission and vision at this point but one thing I do want to restate clearly is that we are a 501(c)(3). That means we are a nonprofit and that we survive on your support as members. So if you havent considered supporting the DHC we welcome the support. The other thing I wanted to mention is, you know, when you read through our vision statement the important thing to keep in mind is that we have a lot of different voices represented. If you look around this room you can see a lot of the digital health industry represented in this room and its not just one group at the table. I think what makes us unique is that were not just a pharmaceutical group, not just representing the pharmaceutical companies and the agencies. We have a lot of diverse views and we want the DHC to be comprehensive. Thats one of the main points that we set out with from the beginning and the other point that we also want everyone to keep in mind is that theres one thing thats of utmost importance as we go through the conversation this afternoon, this is the patient. When we started this organization last year one of the first things that we did was we put together this document that represents what we believe as the Digital Health Coalition. And if you read through this document what youll find is that the patients are mentioned quite a bit, almost in every single one of the belief statements. And we think that is very important. We should always think of putting every project through the filter of the patient -- at the center of the system. And if you havent seen these DHC What We Believe statements you can go to our Facebook page to learn more. http://www.facebook.com/digitalhealthco So with that I want to turn it over to Mark whos going to talk a little bit about the changes that were going to see in 2012 with the Digital Health Coalition and then go through the guiding principles in the remaining ten minutes or so that we have.

Copyright 2012 | Digital Health Coalition | All Rights Reserved

DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

MARK BARD:

All right, thank you and Ill do my best to keep us on track. Were going to hopefully soon add a YouTube channel to that Facebook and Twitter mix. We just have to get more aggressive on video. Those of you who are interested in showing your lovely face on videos we are very interested in hearing from more members out there. You can do it on your web cam -- off your laptop. The idea is to try and get everyone sharing information. If you look around this room youre going to see its a little bit of a different and diverse mix. The DHC is about a third pharma and device manufacturers. We are about a third technology and media companies. Were also trying to get a lot of the independent thought leaders out there involved, folks who are ex-FDA, legal and regulatory -- the idea is to get people involved who are doing things today. I love asking the question at conferences will the legal and regulatory people please stand up? And they never show up at most digital events and we know why. Theyre in the room today. Youve got some of them in the room today. We had to convince them that this would be interesting and productive dialogue and we plan to deliver. What weve tried to do was pull in a lot of the legal and regulatory folks and its not about being an evangelist for digital. I love speaking with the contrarians as much as the people that believe digital is going to change the future as you can be a contrarian and say I dont know why were doing this but you ultimately agree that the world is changing. We need to put some guardrails in place that we can all agree on. It comes back to the frustration of why this group was created. We kept hearing everyone saying, why cant agencies come up with solutions? Agencies saying why cant pharma tell us what they want to do? And of course the agency saying we would love industry to propose practical solutions using technology solutions and approaches that are compliant. So we end up with this stand off in the industry. Its been that way for so many years. Thats really what were trying to do with the DHC, to get people talking. A lot of the people we are working with weve tried to bring into the fold for certain reasons. You believe in the future but you also believe that there are practical solutions and we dont have to spend two, three, four years trying to work around some of these solutions. I highly encourage you to talk with your colleagues throughout the day today. Youre going to see youve got a very diverse audience in here. Were trying to move the conversation forward. Very quickly and Im going to have to really speed up when I go through the principles that were going to come back to throughout the day. If you look at these columns here and this is just to give you a little background. I know that some of you are always interested in learning more and say Hey, Mark, whats going on with the DHC? Where is this group headed? When we started the idea was a third

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

pharma and device companies, a third technology and media and we said a third other independent experts and thought leaders and patients. And of course a really important segment to include is the patients. The tough thing when trying to include patients -- and youve probably heard me say this if youve talked with me one-toone -- you cant have hundreds of patients as part of the coalition. We have been trying to find ways to bring a lot of these groups that represent patient advocates or patient advocacy. The e-Patients are out in the audience today as well. Were also working on a project with Klick Health, the e-Patient Bill of Rights. We can follow up with anyone interested in getting involved with the project. We know we need to bring patients into the conversation. Its an important point. The largest single segment of the DHC is technology and media companies -- and thats important. I think in many ways its the technology and the media vendors out there defining the future, youre the ones building the widgets. But youve got to build widgets and solutions that are compliant -- and youve got to talk with the manufacturers because ultimately we all have to find ways to say okay, were on the same page in terms of what were looking at here. I know I cant find a way to condense this to fifteen seconds but Ill try. When we started the DHC we took a different approach and decided to build a group with critical mass to build industry consensus. Taking that approach, you need to get the major pharma and media companies involved. So that was the one thing we looked at and we said -- lets do it, lets just ramp it up. Lets get everyone involved that we can on the pharma and device side. And then you also look and say obviously the patients, lets bring them into the mix. Tribes (by Seth Godin) is a really interesting book about how you get people that are passionate about causes to take action and coalesce around ideas and thats ultimately what were trying to do. What we saw happen -- weve ramped up to close to seventy companies now that are in the mix and you start to realize there are approximately fifteen or so of those companies really driving the agenda as expected. You find individuals that are really passionate and one of the cool things I think I learned reading Tribes is that the people you really want to latch on to from a leadership perspective are people that bring others into the group. Theyre people who really believe in what theyre doing. So weve really focused on that. Weve got a number of companies that have been very great for the DHC and its folks like, Alan Shapiro at EverydayHealth, John Kamp at The Coalition for Healthcare Communication, Joan Mikardos at Sanofi, Bill Drummy at Heartbeat, and Lee Segal at Klick. They believe this is the right thing to do. Lets figure out how to move this forward.

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

Social media in health is where we spend a lot of the time as a group. This is a tough one. You can take the approach to try and write a 400 page legal brief or you try and build consensus for macro themes, not tactical solutions but macro themes. As Im going to get into the social principles there are really two out of the seven that are really sticking points that we plan to spend most of our time on over the next couple of weeks and months. As you know, we are not able to issue a guidance document, but we can issue and promote guiding principles and we can build consensus -- not just from within the pharmaceutical industry but widespread consensus. I think youve got to keep coming back to that realization. We deliver a ton of value as a group if we can promote industry consensus opinions. This is collectively what pharma, agencies, technology and patients believe. Why is that important? Because those are documents and opinions and macro themes that you can take to FDA and regulators and engage them in conversation. Weve started those conversations and were working to define what is possible in proposing responsible social media, we want to move this industry forward. As I said, best practices, definitions, control and responsibility Im going to come back to that word a few times the draft represents our latest thinking as a group. We continue to the flesh this out and Ill explain to you what the next steps are as we start to put a little more meat on the bones to these individual principles. We need to do principles that the industry can collectively buy into. Our definition and control may not work for AstraZeneca, may not work for Lilly, may not work for Merck but we need an industry consensus on how we can start to define control. You want to go deeper; you want to throw a broader definition around control? Fine, but we need some industry wide definitions on this topic. As many of you are aware the guidances from FDA (OPDP) will continue to trickle out for the key theme areas. Weve seen off-label. We will see control and accountability and responsibility at some point. We think its critical for industry to promote consensus opinions on these topics. Why? Because we can serve as a voice of education and outreach and communicate what industry can do today and the definition of responsible social media. Im going to run through this very quickly and Im going to focus my time on two out of the seven.

#1 Regulated healthcare companies should endeavor to participate in social media as a means to promote public health, improve patient outcomes and facilitate productive patient/physician relationships.

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

Lets jump into the principles and start with one of the big ones #1, do it for the right reason. I have heard a few of the contrarians look at this principle and say you know what? This is mom and apple pie. Pharma sells pills thats it. Your pharma members can support the idea that social is for public health but you ultimately have to believe that the patient is at the center of this. This is important. Some of the European regulations that came out very clearly stated, hey, if you do social -- do it for the right reasons. Right, we believe this does have to be at the front. This is why the patient is at the center. Youre doing it for the right reasons. If youre doing it for promotional reasons its another game. Weve got regulations for advertising. I dont think anyone disagrees with this principle but we feel its an important one to start the conversation.

#2 Regulated healthcare companies are not responsible for user-generated content online that they do not control. Regulated healthcare companies are deemed to control health and medical content if (i) it owns such health and medical content and has material editorial authority or (ii) it paid for the creation of such content and has material editorial authority over such content.

Im going to spend most time on this second - #2, control. Control was the big issue coming out of conversations over the past several months. This is the critical question -- how do we define control as an industry? One definition a few years back was absolute control. Basically, if you have the kill switch for the site you are in control. I think a lot of us realize thats not realistic based on the nature of digital, social, and publishing platforms today. There are shades of grey in social. We have to start with a responsible definition of control. This principle was circulated and debated with the various pharma members. As you know, the agencies will support any definition of control. They just want a definition of control so they can get to work. So the current definition the concept of owned content and material editorial authority and paid for content and material editorial authority. There is also another concept related

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

to control that we are discussing, as a group, that we think is incredibly important. Either it goes here or it goes in another one on transparency, is when a regulated company inserts a compliant post into social media. Obviously youre responsible for the post. Our position -- and I believe its the position of ninety percent plus of the members -- is that you are not liable, you are not responsible, and youre not in control of the subsequent conversation following that post. The subsequent conversation is free speech. Were trying to put some concrete language around that example. Obviously theres the issue of spirit and intent, which is critical here. If youve made twelve posts over a twelve-month time frame and those posts have the same spirit and the same type of content these are issues I think we need to look at as a group from the best practices perspective. What weve heard from a lot of folks in the industry is we have to come up with a better definition of control. Its up to this group to really start to surface this and expand this. The one thing were doing right after this meeting is that were forming what were calling The Control Commission. Its a very Bat Man sounding name, right? What were doing is surface and promote the best practices specific to control. The tough thing is adding anything to the we have control column. Youre fighting a lot of companies that dont want anything else in that we have control column. We need a better definition around third party posts in social media. We want your examples where control has not been established and we want to build consensus around those situations.

#3 Regulated healthcare companies have a responsibility to report adverse events they become aware of. Regulated healthcare companies should follow the existing adverse event reporting rules in place at the FDA.

The next principle - #3, adverse events. What were realizing is that if youre in pharma youre probably in agreement with this principle. This is what were hearing in the market. End of the day, this is not a regulatory issue, it can be handled and addressed. Its not a technology issue. You just have to invest in infrastructure and track it. The challenge in this space is that you could be compliant from a regulatory point of view but your legal is going to shut it down. Thats probably about half the industry thinking today. Its a great conversation. Were not going to solve it here. Its a product liability issue. Youre probably hearing it if youre in a pharma company. You

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

may have also heard it on the agency side. If you have legal concerns from a product viability perspective I dont think this group is going to be the one to convince your general counsel that you should be doing this because its the responsible thing to do. I think about half the industry is taking what we would argue is the responsible path.

#4 Employees of regulated healthcare companies should disclose their material company relationship when posting comments/content or engaging in an online conversation relating to a company product or relevant healthcare issue.

The next principle - #4, transparency. Basically if youre employing people, posting comments, fully disclose that relationship. Heres an interesting one and this one is related to posting a third party comment. Imagine someone at Roche decides to post a comment into a third party community -- theres the issue of transparency. What we may also build into this definition is the concept that the post must be compliant but then also limit control and responsibility to just that post. We think thats an issue of control but we may actually end up addressing that in more detail under this post as well. Hopefully theres a lot more conversation we get going throughout the day on this issue.

#5 Regulated healthcare companies should endeavor to respond to questions on sites they control within a reasonable period of time, and to implement reasonable measures to enable timely responses to crisis and emergency situations.

The next principle - #5, endeavor to respond to questions in a timely manner. This is where the legal folks heads explode as well. What is a reasonable time? We think we have to get to this as an industry first and then as individual companies and partners second. I think it was Sanofi that mentioned they were monitoring social. If you are in it you are in it and you are monitoring it.

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

Reasonable time is not your definition of reasonable time. Right, youve got crisis, emergency and canned responses. Lets get some best practices and agree to that as an industry.

#6 Regulated healthcare companies should endeavor to make reasonable efforts to correct misinformation that is factually incorrect.

The next principle - #6, reasonable efforts to correct misinformation. This is probably one of the most loaded yet shortest principle. Its interesting because I think it forces you to have a lot of difficult conversations. This also touches on issues like Wikipedia among other things. Yes, we do have widespread support for this principle today. I think a lot of the agencies still come back and say your pharma companies support this? They do. Of course the devil is in the details. Endeavor is chosen for a specific reason, endeavor to correct misinformation. An important point here if you are going to make changes, if you do go down this path of correcting misinformation you better do it across the board. Be fully prepared. Have a filter in place, unique visitors per month, traffic filters, and content filters. For example, make it clear --here are the sites were tracking. Dont cherry pick sites and content it will not end well. You cant have your cake and eat it too on this one. If youre going down this path youre going down this path.

#7 Regulated healthcare companies should endeavor to appoint employee(s) tasked with the role of patient liaison focused on representing the best interests of the patient online.

The last principle #7, representing the best interests of the patient. We are trying to bring back in that patient-focused concept we mentioned at the beginning. This one is really the other bookend to the first principle do social for the right reasons -- public health. A key question here is can a pharma or device company really have someone represent the best interests of the patient? This is tough because we actually had a fair amount of push back on this from pharma and device companies. One of the

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DIGITAL HEALTH COALITION: SOCIAL GUIDING PRINCIPLES SUMMIT

key questions Are we really supposed to represent the best interests of the patient? Ill say it another way. Were a contributing factor in this conversation but we cant possibly be in charge of representing their best interest as a liaison. So this is one I think we need to debate and discuss and figure out what are some of the best ways to put this into practice as a principle. Is pharma simply a contributing factor? On the implementation and tactical front, there are companies that do employ people to represent the interest of the patient in social today. Of course that is not the norm. I can count on one hand the companies that are doing that today. Its normal in other industries. If youre going to engage in this how are you thinking about the end customer? You have to put some resources against it. So that concludes the seven principles. We look forward to hearing your feedback and continuing the process to refine, promote, and evolve the principles. As mentioned, our ultimate goal is to build widespread industry consensus specific to responsible social media. We will also continue to engage with regulators in an effort to educate them about the latest thinking within the industry defined as all players in the industry and also continue a mutually beneficial and respectful dialogue with the end goal of fostering an environment where innovation can flourish for the benefit of the patient, physician, pharma, and the technologists seeking to build a better future.

Digital Health Coalition www.digitalhealthcoalition.org www.facebook.com/digitalhealthco www.twitter.com/#!/digitalhealthco

Mission The Digital Health Coalition, a nonprofit organization with 501(c)(3) status, was created to serve as the collective public voice and national public forum for the discussion of the current and future issues relevant to digital and electronic marketing of healthcare products and services.

Copyright 2012 | Digital Health Coalition | All Rights Reserved

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