The American Bar Association will hold its third Medical Device & Healthcare Technology Compliance Institute, October 13-14 in Washington D.C., covering the latest on compliance topics and issues affecting the medical device and healthcare technology industry.
Here is what you should know.
1. The conference features 36 faculty speaking on a variety of issues including: fair market value, cybersecurity, privacy and HIPAA, promotion and reimbursement, counseling executives and boards, managing false claims acts and more.
The program will also focus on the security of medical devices in light of their continued market adoption.
2. Conference co-founder Phil Brewster, founder of Brewster Law Firm, who started the conference with Michael Clark, Special Counsel at Duane Morris’s Houston office, highlighted a few speakers in particular in a recent conversation.
One of those presenters is Michael Carvin, partner at Jones Day. Mr. Carvin is a Supreme Court advocate who recently challenged the Affordable Care Act in front of the Supreme Court in King v Burwell. He will be part of a broad presentation on truthful speech and "off-label" marketing. He will also be part of an in-depth discussion with three other panelists on off-label marketing developments and recent First Amendment cases and the practical effects they have for medical device companies.
3. Supervising Special Agents John Robertson and James Klatt of the Federal Bureau of Investigations will participate at the conference. Special Agent Klatt will speak on cybersecurity as it relates to the medical device industry.
The FBI also presented at last year's conference, which Mr. Brewster says was one of the highlights of the week.
Last year's presentation featured insight on the future of the industry and the investigator shared a story on how the FBI apprehended a cybercriminal that was attempting to leave his job at a medical device firm and flee the country with stolen intellectual property . The FBI, working with the device company, was able to apprehend the defendant and recover the stolen data.
4. The conference will also feature the defense counsel for Howard Root, CEO of Vascular Solutions. Mr. Root was the defendant in a criminal case over off-labeling medical devices in which he was found innocent. His defense counsel will review "recent prosecutions." The panel will be presided over by Mark Leahey, the president and CEO of the Medical Device Manufacturers Association.
5. In addition to the highlighted speakers, the conference will feature a compliance officer roundtable; a discussion on the Yates Memorandum; Sandra Sands, of the Department of Health and Human Services Office of the Inspector General, sharing perspectives on trends involving medical device enforcement and much more.
The conference will be held at the conference center of Jones Day. The intimate setting allows for more conversation, a fact that Mr. Brewster relishes.
"We try to have a much more engaging conversation," Mr. Brewster says. "It tends to be smaller and more intimate than your traditional conference. We have the liberty to run a smaller program and we take advantage of that."
The conference is being held for medical device and healthcare technology executives, corporate employees who manage compliance programs, government attorneys, various types of legal counsel and for anyone who wishes to increase competency in effectively managing medical device and healthcare technology regulatory risk.
The Third Medical Device and Healthcare Technology Compliance Institute Conference will be held Oct. 13 and Oct. 14 at Jones Day, in Washington D.C. The conference is hosted by the American Bar Association. Click here to learn more.
More spine and orthopedic device news:
AJRR reaches new milestone with 500k+ procedures in system: 4 things to know
Medtronic Q1 profits hit $929M, revenue down 1% to $7.1B: 8 things to know
Medtronic Q1 profits hit $929M, revenue down 1% to $7.1B: 8 things to know