Rush to Social Media Exposes Health-Care Companies to New Legal Risks
Providers in the heavily regulated health care industry are exposing themselves to new legal risks by racing into social media -- sometimes without needed guidance from agencies and sometimes oblivious to the rules that come along with virtual equivalents to conventional offline activity, speakers said Wednesday on an American Bar Association webcast and teleconference. More than 500 hospitals have Twitter accounts, almost as many have Facebook pages, members of the industry have more than 500 YouTube channels to themselves and almost 90 host active blogs, said Rosemary Plorin, a marketing consultant. The numbers would be even higher if not for the “reticence and outright resistance” of health care and life sciences companies scared off by legalities, said lawyer Michael Manthei of Holland & Knight.
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Hospitals and other industry bodies use social media for e-commerce, registration and clinical trials, in addition to broad marketing and the promotion of expertise in specialties, Plorin said. Biotechnology and life sciences companies use social sites to send customers warnings and recalls narrowly or broadly, often to comply with government requirements, she said. Surgeries have been tweeted live, she said.
The coverage of Food and Drug Administration rules on ads and labeling is broad enough to include “almost anything in writing about a product,” including statements on social media, Manthei said. “The FDA has no specific regulation on Internet promotion or the use of social media.” The Communications Decency Act would seem to give health companies, like others, immunity for statements by others that they post, but “the FDA basically doesn’t acknowledge it,” he said. Many life sciences manufacturers have websites, but all comments are attributable to them, and that has “stunted the use of social media,” Manthei said. “This to me is a problem,” considering how central Web 2.0 technology is in the world, he said.
In response, many companies finance others’ sites, such as those about particular diseases, Manthei said. But “I'm not sure this necessarily solves the problem” of legal responsibility for the statements of others, he said.
Recent FDA hearings on the subject show that the government “is trying to respond” to the problem, Manthei said. But “there has been no further activity” by the FDA in the months since, he said. So the hearings have simply confirmed the legal risks, Manthei said. The FDA put “up for debate” a one-click principle that manufacturers have relied on in the belief that required disclosures are adequate if they're within a click of a mention of a product, such as on a banner ad with little space for legal notices, he said.
Meanwhile, companies are overlooking the need for compliance concerning online activities that are the equivalent of offline conduct well-known to be regulated, Manthei said. These include dealings by life sciences companies with purchasing hospitals, prescribing physicians and the websites of academics and patients, he said. Payments to these players raise issues under fraud and abuse laws and federal regulations just like those with the conferences and other conduits they're replacing, Manthei said.