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As we have previously reported, in less than two weeks the FTC will host its anticipated workshop on big data and discrimination.  Today the FTC announced a full agenda and panelists for the September 15th event, “Big Data: A Tool for Inclusion or Exclusion?” which will take place in Washington, D.C., at the Constitution Center.  The workshop is open to the public, and registration begins at 8 a.m.  The following provides a full schedule of speakers and panels.…
Continue Reading Schedule of Panelists for FTC’s Upcoming Big Data & Discrimination Workshop

This morning, the FTC announced that it would host a public workshop in September entitled “Big Data: A Tool for Inclusion or Exclusion?” in order to examine the increasing use of big-data analytics and its potential impact on low-income, diverse, and underserved American consumers.  The FTC noted that while predictive-analytic techniques produce tremendous benefits by enabling innovation in medicine, education, and transportation, and in improving product offerings, manufacturing processes, and tailored ads, there is concern that insights from big data also “may be used to categorize consumers in ways that may affect them unfairly, or even unlawfully.” 

The FTC gave examples of such practices that could limit certain populations of consumers’ access to higher quality products or services, including:  (1) rewarding frequent customers with better service or shorter wait times; (2) offering a discounted mortgage rate to a consumer who has a checking, savings, credit card, and retirement account with a competitor; (3) providing offers for “gold level” credit cards to high-income consumers while offering low-income consumers subprime credit cards; (4) circumventing the requirements of the Fair Credit Reporting Act by assessing credit risk through unregulated “aggregate scoring models,” which are based on aggregate credit or demographic profiles of groups of consumers who shop at certain stores, rather than the credit characteristics of individual consumers.  Although these types of uses of big data may be thought to bring about convenience, efficiency, and economic opportunity for some, consumer advocates have urged businesses and regulators to ensure that such techniques be implemented to respect the values of equality and opportunity for all.

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Continue Reading FTC to Examine Impact of “Big Data” on Low-Income and Underserved Communities

Earlier this month, we blogged about the California Senate’s passage of the bill titled “Privacy Rights for California Minors in the Digital World”, which prohibits certain targeted advertising to California minors and requires that minors be allowed to delete materials they have posted online.  Yesterday, California Governor Jerry Brown signed the legislation, and it…

On September 19, HHS released additional guidance on the “refill reminder exception” in HIPAA, which allows — in some circumstances — paid communications regarding a drug or biologic currently prescribed to a patient.

Background

In January 2013, HHS finalized new restrictions on marketing as part of the final omnibus rule implementing changes to HIPAA under the HITECH Act.  The new rules modified how and when covered entities and business associates may receive financial remuneration from a third party for making communications about a drug or biologic currently prescribed to an individual (i.e., “the refill reminder exception” to the marketing prohibition).  We previously discussed the new restrictions here.  In short, the new rules prohibit any financial remuneration above and beyond what is reasonable.  HHS indicated that reasonable remuneration would include  the costs of labor, supplies, and postage to make the communication.  These restrictions appeared to prohibit a covered entity or business associate from generating a profit to make these subsidized communications.

As we discussed earlier, these new restrictions were challenged in a lawsuit filed earlier this month by Adheris, Inc..  Since the filing of the complaint, HHS announced that it would promulgate additional guidance on the refill reminder exception.

HHS Guidance

The new guidance describes both the scope of communications that fall within the exception and what third party payments are considered “reasonable” under the statute and regulations for making such communications. 

What communications are included in the exception?

HHS explains that the following communications are permitted under the exception:

  • Refill reminders.
  • Communications about generic equivalents of a drug being prescribed.
  • Communications about a recently lapsed prescription (one that has lapsed within the last 90 calendar days).
  • Adherence communications encouraging individuals to take prescribed medicines as directed.
  • Where an individual is prescribed a self-administered drug, communications regarding all aspects of a drug delivery system.

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Continue Reading HHS Issues Guidance on Refill Reminders under HIPAA

This post is part of our series on key aspects of the final HITECH omnibus rule issued by the U.S. Department of Health and Human Services (HHS) on January 17, 2013 (available here), and scheduled to be published in the Federal Register on January 25.  Previous posts are available here.  The regulations are effective March 26, 2013, but covered entities and business associates have until September 23, 2013, to comply with most new requirements.

The final HITECH omnibus rule significantly tightens the HIPAA marketing restrictions.  As described below, HHS has modified the proposed approach to require authorization for almost all treatment and health care operations communications where the covered entity receives, from a third party, financial remuneration for making the communication.  This change will have major implications for the design of medical messaging programs.

Background.  The HIPAA Privacy Rule generally requires that a covered entity obtain prior written authorization from an individual before using that individual’s protected health information for marketing purposes.  Prior to the HITECH Act, certain communications, including those related to treatment and care coordination, were excluded from the definition of marketing.  But under the HITECH Act, if a covered entity or business associate receives direct or indirect payment in exchange for making certain communications (including those related to treatment and care coordination), the covered entity generally must obtain prior authorization–unless the communication qualifies for a limited exception for communications about currently prescribe drugs or biologics where the payment received is reasonable in amount.

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Continue Reading HITECH Update #5: HHS Tightens HIPAA Marketing Requirements

Earlier today, members of Congress and regulators gathered for a symposium on “The Impact of Media on the Health & Well-Being of Children.”   Participants included Congressman Edward Markey (D-MA), Congresswoman Debbie Wasserman Schultz (D-FL), Senator Richard Blumenthal (D-CT), Jon Leibowitz, Chairman, Federal Trade Commission, and Mignon Clyburn, Commissioner, Federal Communications Commission, as well as researchers and members of the public interest community.  In response to a question, Chairman Leibowitz informed the audience that the FTC expects to issue a revised Children’s Online Privacy Protection Act (“COPPA”) Rule by “the end of the year and hopefully sooner.” 

During their remarks, Congressmen Markey and Wasserman Shultz each expressed support for the Do Not Track Kids Act of 2011 (H.R. 1895), which we have blogged about here.  The bill would expand privacy protections for minors under the age of 18, including a prohibition on the use of personal information for targeted marketing to minors and a requirement that website operators provide “eraser buttons” to enable the deletion of personal information shared publicly by minors.  Senator Blumenthal also indicated that he was supportive of the legislative proposal, which he described as “common sensical,” although he stated that there likely would be substantial concern among advertisers and other stakeholders about implementation issues.

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Continue Reading Members of Congress Examine Impact of Media and Marketing On Children

The Federal Trade Commission recently announced a preliminary agenda for its upcoming public workshop called Advertising and Privacy Disclosures in a Digital World.  The goal of the workshop is to discuss revisions to the Dot Com Disclosures, the FTC’s current guidance document on online advertising disclosures, which was published in 2000. The Dot…

On July 13, the Personal Data (Amendment) Bill 2011 was introduced to Hong Kong’s Legislative Council for final approval.  The Bill, which is designed to implement the recommendations of a April 2011 government report on privacy reform, aims to address a spate of recent concerns about the prevalence of direct marketing-related data sales and transfers…