What happens on social media doesn’t stay on social media, and other lessons learned at the #HCCAci

Social media was the issue of the day at the Health Care Compliance Association’s Compliance Institute (CI), which was held in Law Vegas, Nevada this year. Throughout the four-day event, health care compliance professionals tweeted, pinned, and “Instagram-ed” their way through the lectures, discussions, and networking events, while at the same time, ironically, learning a great deal about the growing popularity of social media and the dangers it may pose when it comes to your compliance program.

Even before the CI began, attendees were invited to follow the CI Pinterest page and begin to tweet and post pictures to Instagram using the hashtag #HCCAci. During the conference, social media savvy professionals were invited to network in a “Tweet Up” event; even after the conference was essentially over, participants let loose and posted pictures of their adventures in the City of Lights. As such, the role that social media plays in our current professional and personal realms was plain to see simply through the role it played at the CI this year alone.

At the general sessions that kicked off the conference both Dan Levinson, Inspector General (IG), and Leslie Caldwell, Assistant Attorney General of the Criminal Division of the Department of Justice (DOJ), noted that areas of health information security and privacy were among the most important areas to watch. In many of these arenas, according to Caldwell, the government is often behind the learning curve. As such, it would behoove compliance officers to look beyond the guidance put out by these agencies and into the future, with an eye to what new technologies are available and how they are being used.

Donald A. Sinko, Chief Integrity Officer at the Cleveland Clinic and a presenter at this year’s CI, once said that, “One of the greatest risks of social media is ignoring social media.” Presenters at breakout sessions at the CI took heed of that sentiment and focused many of their lectures and discussions on the role that social media and social media-related issues are playing in the compliance world. Most notably, Frank Ruelas, in a presentation “#HIPAA: How Social Media Impacts HIPAA Compliance,” drew lines between how many people use social media, for what purposes, and how those practices can lead to HIPAA breaches in the health care provider environment.

Ruelas encouraged audience members to volunteer their own stories about how social media affected their compliance officers, noting that it makes sense to think about social media–which is often driven by the youth population–and HIPAA together because HIPAA is a teenager itself. Ruelas concluded by urging compliance officers to “codify, illustrate, and judiciously enforce expectations” when it comes to social media use in the workplace in order to get closer to an effective compliance program. In a related presentation on emerging challenges in mHealth, David Holtzman and Web Hull, discussed how mobile health apps and wearables are playing a larger, and in some cases more concerning, role when it comes to health data privacy and security. As Hull put it, the biggest challenge concerning mHealth “is that what we are dealing with now is just the beginning.”

The second day of general sessions brought about a seeming round up of the issues discussed in the previous day’s general and breakout lectures from a somewhat surprising source. Cam Marston, a researcher of generational trends in the workplace and marketplace, spoke to the CI crowd about how individuals in different generations (baby boomers, “Gen Xers,” millennials, etc.) differ in terms of their backgrounds, the ways they were raised, how they act in the marketplace, and, most importantly, how their work attitudes and styles differ. The biggest gap between the generations with regard to work environment and marketplace is perhaps the issues involved with the advance of technology, including the growing popularity of the reliance on social media in our personal and professional lives.

In Ruelas’ social media discussion, one compliance officer in the audience mentioned that one of her employees was found to be taking pictures, that were perhaps in violation of HIPAA, and posting them on Snapchat, an image messaging app and social media outlet. She explained that in order to truly understand the problem she had asked younger people in her family to help explain Snapchat to her and had obtained the app for herself and started using it in an effort to understand how it functions. In this way, we can see how it possible to bridge the divide caused by social media use and embrace its existence in a health care setting. Ruelas explained to his audience, social media “runs through the veins” of its users and, therefore, assuming that they will not use it at work without having policies that explicitly prohibit or explain proper use of it is not a good avenue to go down.

As the role of social media takes up more of our lives, it takes more of our work as well. As such, it is promising to see how compliance professionals are embracing it as both a tool for their own networking and knowledge spreading and recognizing it as a potential outlet for compliance issues in the workplace. Although what happens in Vegas may stay in Vegas, what happens on social media is for the world to see, and, as such, compliance professionals should be on notice of that.

FTC hopes helping health app developers will protect consumers

It should be easier for creators of health-related mobile applications (apps) to find applicable federal laws and regulations, thanks to a new interactive tool released by the Federal Trade Commission (FTC) in cooperation with HHS, the FDA, the Office for Civil Rights, and the Office of the National Coordinator for Health Information Technology (ONC). Along with the new tool, the FTC simultaneously released a best practices document for mobile health app developers, focused on privacy and information security.

Health apps

There are hundreds of thousands of mobile health apps available in the iTunes and Google Play app stores, including apps for creating tailored training plans, running, social media, and tracking food and sleep. PricewaterhouseCoopers identified health apps used as medical devices, and do-it-yourself health care as top health industry issues of both 2015 and 2016. The information used by health apps may implicate a number of federal laws, including the FTC Act (15 U.S.C. §§41-58), the Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191), and the federal Food, Drug and Cosmetics Act (FDC Act) (21 U.S.C. §301 et seq.).

Interactive tool

The tool is an interactive website that asks developers a series of high-level questions about the nature of their app. The questions cover the app’s function, the data it collects, and the services it provides to users. The guidance tool then points the developer toward detailed information about applicable federal laws and regulations based on the answers. The tool defines terms like “identifiable health information,” “HIPAA covered entity,” and “personal health records provider.” Questions include the following:

  • Do you create, receive, maintain, or transmit identifiable health information?
  • Do consumers need a prescription to access your app?
  • Is your app intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease?
  • Do you offer health records directly to consumers (or do you interact with or offer services to someone who does)?

Best practices

The FTC provided mobile health app developers with guidelines on best practices to build privacy and security into apps and comply with the FTC Act. It recommends determining whether the app needs to collect and retain health information, noting, “if you don’t collect data in the first place, you don’t have to go to the effort of securing it.” The best practices also suggest limiting the app’s access to unnecessary consumer information, such as the mobile user’s contacts list, choosing privacy-protective default settings for users, and making sure to be simple, clear, and direct in communicating notice to users about the data collected and stored.

PhRMA and MIWG Challenge the Constitutionality of the FDA’s Twitter Guidance

By Vaughn Bentley, DePaul University College of Law-

The Food and Drug Administration (“FDA”) recently released a draft guidance for pharmaceutical companies looking to advertise on Twitter, Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. The guidance makes it illegal to advertise only positive benefits of drugs on social media without having a negative effect in the same posting. Since the release of the guidance in the June of 2014, the pharmaceutical companies have responded with a chorus of objections and outcry. One of the more interesting objections the pharmaceutical industry has raised is that the draft guidance is unconstitutional.

Pharmaceutical Research and Manufacturers of America (“PhRMA”), a trade group that represents the country’s leading biopharmaceutical researchers and biotechnology companies, is one of the groups challenging the constitutionality of the draft guidance. According to PhRMA, the FDA is not applying the same standard to manufacturers as it would apply to any federal agency. PhRMA illustrated its argument by pointing to a tweet posted by the FDA, regarding a new diabetes drug, that would not have passed muster under the draft guidance. The tweet in question simply stated that the FDA had approved the new drug with a link to the news release about the approval. PhRMA noted that 60 people had retweeted the news. The draft guidance suggests manufacturers could be punished for retweeting the news. The trade group went on to comment the FDA could not punish the retweeters for simply repeating what the FDA had said. PhRMA suggests this violates First Amendment logic and law by claiming the FDA using Twitter in a seemingly advertising way is truthful, while a manufacturer doing substantially the same would be misleading.

The Medical Information Working Group (“MIWG”), a coalition focused on pharmaceutical promotion, is challenging the draft guidance on separate, but still related First Amendment grounds. MIWG argues that the guidance is “tantamount to a ban on the use of space-limited communications.” MIWG draws support from Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011). In IMS Health Inc., a Vermont statute restricted the sale, disclosure, or use of pharmacy records revealing the prescribing practices of individual doctors. This included the marketing of pharmaceutical products to individual physicians, which is made easier if the manufacturer knows the physician’s prescription practices. The Supreme Court held speech in aid of pharmaceutical marketing is a form of expression protected by the First Amendment. MIWG draws comparisons between the marketing restriction held unconstitutional in IMS Health Inc. and the marketing restricted under the draft guidance. The MIWG claims the draft guidance is unconstitutional because it targets manufacturers, a specific class of speakers, and truthful statements about medical products, a specific type of speech.

Others are claiming that the draft guidance amounts to the FDA criminalizing the use of Twitter by pharmaceutical companies. The guidelines state that if a manufacturer cannot fit the required benefits and risks into the character limits imposed by Twitter, the manufacturer should reconsider using Twitter or other social media platforms. While characterizing this policy as ‘criminalizing’ may be extreme, at minimum, the FDA’s guidance has the potential to discouraging social media use.

Nevertheless, the guidelines are still in a draft form and the FDA may still decide to alter the guidance to operate closer to “dot com disclosures.” Under a FDA guidance from last year, pharmaceutical manufacturers can make a disclosure of the risks clear and conspicuously on the page linked to in a space-constrained ad. The FDA could apply the same logic to tweets from the manufacturers.

It is unclear how the FDA will proceed in light of these constitutional challenges. Some commentators have speculated if the FDA will continue to push forward with the draft guidance in light of these recent objections. For the time being, the comment period has been expanded until October 29. Regardless, it will be interesting to see how the FDA, in the coming months, adjusts its policies in light of twenty-first century media.
Vaughn Bentley is a student at DePaul University College of Law, and is expected to graduate in May of 2016. Vaughn attended State University of New York, College at Oswego and is the DePaul Health Law Institute Vice Chair of Marketing, a writer on the Journal of Health Care Law and the DePaul Health Law Institute E-Pulse. Vaughn is a Johnson Law Scholarship recipient and was on the Dean’s List in the Fall of 2013 and the Spring of 2014.

Stop Smoking Campaigns: Hit Teens Where They Live

Whether anyone knows it or not, November 20, 2014, marked the 39th anniversary of the American Cancer Society’s (ACS) Great American Smokeout. The event takes place the third Thursday of every November. The event challenges tobacco users to stop using the harmful products on that very day and is geared to make tobacco users aware of tools they can use to help them quit and “stay quit.” In November 2014, the Centers for Disease Control and Prevention (CDC) wrote that youth smoking rates will cause their early demise, but are young adults and kids paying attention? Have they ever heard of the Great American Smokeout?

The event is publicized on the local level and rallies volunteers to press for laws that control tobacco use and discourage teen tobacco use. The event highlights strategies for quitting such as: telephone smoking-cessation hotlines; online quitting support groups; nicotine replacement products; and family and friend support. The ACS notes that a combination of strategies works best to keep people tobacco-free.

Humble Beginnings

According to the ACS, the Great American Smokeout began when during a 1970 event in Massachusetts, Arthur P. Mullaney asked people to give up cigarettes for a day and donate the money they would have spent on cigarettes to a high school scholarship fund. That sparked a Minnesota editor to front her state’s first “Don’t Smoke Day” in 1974, and two years later, the California Division of the ACS was able to get almost 1 million smokers to quit for the day. The ACS credits the movement with the many state laws that now ban smoking in public places; raise taxes on cigarettes, limit cigarette promotions, and discourage teen cigarette use.

Statistics

The Surgeon General January 2014 report claims that 5.6 million youth currently aged zero to 17 will die prematurely from a cigarette smoking-related illness unless youth smoking rates drastically drop. The CDC sees combustible tobacco products such as cigarettes, cigars, hookahs, and pipes, as the main culprit.

A November 2014 Morbidity and Mortality Weekly Report (MMWR) reports that almost 23 percent of high school students currently use a tobacco product. According to the CDC’s 2013 National Youth Tobacco Survey (NYTS), 46 percent of all high school students and 17.7 percent of middle school students reported using a tobacco product at least once. Further, youths who say they use more than one tobacco product are at higher risk for developing nicotine dependence that can lead to continued smoking into adulthood. The NYTS indicates that “most youth who use tobacco believe they will be able to quit, but about three out of four high school smokers continue smoking into adulthood.”

Other Efforts

Other smoking cessation efforts have included the FDA’s launching of The Real Cost in February 2014. The year-long national marketing campaign is aimed at youths between the ages of 12 and 17. Additionally, CVS stores removed all tobacco products from store shelves in September 2014.

Advertise!

The stop smoking efforts are admirable, but useless, if the audience they target does not even notice. When asked in November 2014 whether they have heard of the Great American Smokeout, 40 Nevada teens said, “The Great American what?” Smoking cessation campaigns like the Great American Smokeout should be bombarding online video games, Instagram, Twitter, Tumblr, Facebook, Vine, and any other social media site that teens use in order to make the difference that the Surgeon General and American Cancer Society desire.