HIPAA Regulatory Alert

EPIC warns about DTC marketing databases

Concern over targeting vulnerable groups

The Electronic Privacy Information Center (EPIC) West Coast Office has told the U.S. Food and Drug Administration (FDA) it is concerned about an issue in direct-to-consumer (DTC) medical marketing that it believes has received inadequate attention — use of databases of personal information to target individuals with medical ailments through direct mail or other forms of direct marketing.

"We are concerned that heightened attention to traditional mass-circulation print and broadcast advertising will result in marketers increasing information collection efforts for targeted solicitations," EPIC senior counsel Chris Hoofnagle said in comments to FDA.

EPIC said there are several reasons why a shift to more direct marketing presents risks to privacy and consumer welfare. First, it said, data brokers (companies that amass personal information and sell it to marketers and others) can enable targeting of DTC advertising to vulnerable populations. That risk is exacerbated by the fact that, unlike mass-circulation print and broadcast advertising, targeted solicitations are harder for public health authorities to monitor.

Second, according to EPIC, medical information often is gathered in a deceptive fashion, such as consumers being presented with product warranty or registration cards that solicit medical information, with the false implication that completing the card is necessary to have protection for a product. And finally, EPIC said medical information is being gathered outside the protections of HIPAA's privacy regulation since individuals who give their medical ailment information to marketers have no ability to opt out of the data collection, to access their data or correct it, or to order that the data be deleted.

EPIC urged the FDA to consider risks posed by an increase in use of personal information to target DTC advertising. It said new database technology makes it simple for marketers to target vulnerable groups.