Social media and social networks provide an increasingly popular way for consumer and companies to engage and interact. Consumers are not bound by regulations in the way they communicate. They are free to discuss their healthcare issues with anyone they want. Whether sharing advice on medications and their off-label uses or talking about a weird thing that happened to them medically and “oh-by-the-way” I was taking this medication when it started happening, consumers are free to share this information when and how they want.

For pharmaceutical and insurance companies, these same conversations can cause severe cases of heartburn for regulatory and compliance departments if these topics were to be brought up on a social networking site sponsored by said company. Off-label uses cannot be condoned by the pharma company and allowing a C2C conversation to happen without correcting it may be considered condoning it if brought into legal proceedings. The “oh-by-the-way” discussion could be considered an Adverse Event (AE) and would therefore need to be registered into an AE database that is regulated by the FDA.

As you can see these relatively benign instances that happen all over Facebook, Twitter and other social networks every day fall directly into a regulatory grey area for pharmaceutical and insurance companies. Without direct legislation and regulation, many companies have chosen to stay away from social media for the time being. The problem is that social media is not going away and that social engagement could pave a potentially lucrative path to new revenues and new opportunities for those companies who can figure out how to harness the power of social.

Understanding what regulations are in place and applying them to social we help shape a foundation by which to develop better guidelines for participation in social media and social networks.

Be Clear in Conversations
The range and depth of biotech, pharma and health care regulations are vast. They cover a wide range of areas spanning how you manage clinical trials to manufacturing to sales and control of patient information. While discussing the talking points in this document let’s be clear that our assumptions are that:
     * You are using your social network to manage outreach to bring interested parties into the fold to inform them of where to get information, gather their ideas, priorities and interests, and connect them with other professionals with related interests and expertise. This might include:
          o Foster greater collaboration on new products
          o Improve internal processes
          o Increase the effectiveness and efficiency managing regulatory compliance
          o Enable doctors and patients to more easily access needed information
          o Increasing the efficiency in the delivery of health care through innovation and collaboration
          o Strengthen post-marketing pharmacovigilance their products

     * You are not using your social network to manage clinical trial subject data; drug, biologic or medical device manufacturing data; or safety data

What are the Regulations that Need to Be Considered?

     The two primary bodies of regulation to watch are:
1. Title 21 CFR Part 11 - Title 21, Part 11 of the Code of Federal Regulations (CFR) which deals with the FDA guidelines on electronic records and electronic signatures
2. HIPAA Title II – Health Insurance Portability and Accountability Act (HIPAA) protects the ability for workers and their families to gain access to health care when the switch employers or jurisdictions (i.e., when they move). Title II of HIPPA contains something called The Privacy Rule that governs the use and disclosure of Protected Health Information (PHI).

The other area to understand is how to manage Adverse Events which falls under the term Pharmacovigilance.
1. Pharmacovigilance: Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines

     How to Incorporate These Regulations into Social
The following talking points are meant to address how we can meet regulatory guidelines by implementing technology in very particular ways to mitigate regulatory concerns and still engage stakeholders in a meaningful way.

First, there are two over-riding recommendations when incorporating social media. They are:
1. Separate social networking infrastructure from regulated legacy systems. You do not want to unduly subject your social networking infrastructure to all of the regulations that fall under regulated systems therefore it is absolutely critical to ensure you separate the social networking components of your Health 2.0 infrastructure from your other enterprise systems.
2. House all UGC in a true enterprise data warehouse. By pulling social networking UGC into a enterprise data warehouse and providing your safety monitoring team access to this, you are providing them a new channel to mine and monitor safety information.

With regard to specific regulations, here is how they can be incorporated into social media:

Title 21, Part 11 of the Code of Federal Regulations (CFR) that deals with FDA guidelines on electronic records and signatures. With social engagement, we recommend three key elements:
1. Never Delete: data needs to be Archived or turned “Inactive” not deleted.
2. Use secure, electronic signatures: which relates to only letting authenticated users contribute content (no anonymous contributions).
3. Documentation of Compliance: be able to demonstrate that you have designed, built and tested a system that does the above. This includes documenting requirements, design, test cases and successful completion of those test cases. It also includes demonstration that your configuration management processes ensure that the code you have in production has completed full documentation of the above before going to production.

HIPAA Title II: specifically the Privacy Rule that governs the use and disclosure of Protected Health Information (PHI). We recommend three key elements:
1. Closed Groups – create specific areas that can be closed from general populations (ie.HIV, Diabetes, etc groups). To create even tighter requirements you can apply white list/black list rules to enforce group requirements (even blacklisting insurance domains).
2. Strict Adherence to Profile Information – Do not capture any PHI data fields. Strongly encourage Display Names to not include names or other identifiers (this includes either prohibiting Avatars or only allowing members to pick from a list generic Avatar icons). Finally, encrypt all profile information (and – to assure Part 11 compliance – never delete past profile information.)
3. Moderate all UGC – this is limiting in participation and taxing on resources however there is a mix of moderation and publication that can limit a user’s exposure (through the use of coordinate inputs for instance).
Pharmacovigilance: pertains to patients reporting adverse drug effects. There are a couple of items here including moderation and having a true data warehouse to store your social content and easily mine and manage information and content.

Source: Much of this content was pulled or modified from http://www.exsecutus.com/haughwout/2009/07/health20-ugc-mgmt which is the work of Jim Haughwout.

So now we’ve covered the regulatory side of the issues that pharma faces in social.  So what can they do?  That is what our moderator this week is going to help us figure out.  Moderating this week is Steve Woodruff.  Steve is one of the leading minds in helping to figure out social in regulated industries.  The topic this week and the questions are:

Topic:  Does Pharma REALLY have anything to offer in social networking?

Q1:  I think pharma companies are generally evil and I don’t want to hear from them. Am I right?

Q2:  I have health questions and would really like to hear from these companies. Can they talk?

Q3:  What are pharma companies actually doing in the social space, and is it worth anything?

Join us on Tuesday 9/21 at noon ET for the #socialmedia chat by following #sm78 from your favorite Twitter client or simply follow our LIVE site at www.hashtagsocialmedia.com/live.