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Regulation and healthcare in social media: a quick primer

stethoscopToday I’m giving a talk at the National Association of Medical Communicators Media Skills Workshop in Chicago titled “Understanding Legal Risk, Ethics and Privacy”. Communications professionals working in the healthcare arena face more regulations specific to them than those working in perhaps any other field. Very generally speaking, the regulatory landscape differs for two key groups: those representing hospitals, and other organizations and employers of healthcare professionals; and those who represent pharmaceutical and medical device firms.

In the first group, the primary concern is ensuring compliance with the Health Insurance Portability and Accountability Act (HIPAA), which protects patients’ privacy rights. The guidelines for ensuring compliance with HIPAA in social media outreach are fairly straightforward: don’t identify patients by name or upload photos of video of them to social sites without a signed consent form. In a sense, this is a no-brainer. Would any responsible communications pro use patient names and images in more traidtional forms of marketing without permission? Of course not.

As we’ve advised here before, healthcare professionals who want to engage online with seekers of medical information who are not their patients should keep the discussion general in nature; offer links and resources; avoid offering anything close to a diagnosis or treatment regimen; and use a disclaimer along the lines of those included by many healthcare professionals in the emails they send.

For the pharma and medical device group, things are somewhat less clear cut. Pfizer’s PR chief complained in August that The Food and Drug Administration has not offered pharma companies enough guidance on what they can and cannot do in social media. Two FDA regulations in particular are potentially applicable to social outreach online: 1) adverse event reporting requirements, which state that when a pharma or medical device company encounters a description of side effects by a user of their products, they must report the incident to the FDA, and 2) “fair balance” guidelines, which require pharma companies in all communications, including advertising, to describe side effects in fair balance with the description of good, intended effects of a drug. If your evening of television viewing has ever been interrupted by a graphic description of side effects in a TV commercial, you have this FDA guideline to thank for it.

Legal counsel at various healthcare institutions and pharma companies have different opinions of the extent to which they encounter messages requiring regulatory reporting when they monitor social media. A Nielsen Online study found that due to requirements that the user of a drug must be identifiable, less than 1 percent of social media messages were subject to FDA adverse event reporting guidelines.

As for fair balance requirements, a golden rule of social media marketing is to listen, converse and offer helpful information, rather than pitch your product. If healthcare marketers take that to heart, they may not be faced with the impossibility of trying to describe a long list of side effects in a 140-character tweet.

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