On Oct. 27, 2015, the Annual Meeting of the Illinois Association of Healthcare Attorneys was held at Navy Pier in Chicago. Hundreds of health care attorneys attended, including several from Thompson Coburn. The symposium was loaded with high-quality and insightful sessions, and our attorneys identified the following highlights:
Jan Paul Miller, Thompson Coburn partner and former U.S. Attorney, contributed his knowledge and experience as an ethics plenary panelist on a topic of significant importance to the lawyers attending the annual meeting. The panel addressed pitfalls facing the health care bar as it responds to civil subpoenas from federal agencies regulating the industry. The audience was informed about key differences between subpoenas and the proper response to each. The panel, including Asst. U.S. Attorney Jon Juenger, emphasized that criminal and civil prosecutions are not easily differentiated in the investigative stage. For this reason, counsel must take affirmative steps to anticipate responses in the event that a criminal referral has or will occur.
Life sciences/optimizing new product launches
New drug development and investment is increasingly focused on oncology, neurology and infectious diseases. The panelists explained that these disease conditions are the focus of a disproportionately higher level of funding and investment than all other areas of drug development and medical research. However, the collection and use of “Big Data” represents an opportunity to develop drugs faster (moving from 15 years of development to eight by 2020) and cheaper, but raises privacy and legal issues for members of the industry.
Medical device connectivity
Mobile Medical Devices, Medical Device Data Systems, and other mHealth technologies are becoming ubiquitous in the industry, enabling greater quality patient-centered care to deliver more opportunities for better outcomes. Recent FDA Guidance Documents have better defined the agency's roles in regulating this technology in order to protect patients and providers (see our prior blog post on mobile medical devices). However, app developers, IT leadership and health care providers must be aware of legal ramifications of these products in terms of regulatory compliance and patient privacy (HIPAA).
Beyond HIPAA: State privacy implications
This innovative session involved a hypothetical hack by a “white hat” into a hospital EHR. A white hat is a hacker with benign intent, who doesn’t steal or access data, but alerts the provider to its data security vulnerabilities. The expert panel, including Marilyn Hanzal of the University of Chicago Medical Center, led attendees through a hypothetical that illustrated a matrix approach, incorporating technical and legal responses and their interdependence. Highlights included the reporting obligations under state privacy laws regarding breach notification and how to work through these requirements in a case involving a white hat hacker.