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Quarterly Lectures

IAHA Quarterly Lectures provide a high-level detailed exploration of a current health law topic. The 75-minute lectures feature expert speakers with first-hand experience with the topic and often include spirited audience discussion.

Past lectures have addressed gain sharing/pay-for-performance, problem physicians, managed care contracting, electronic medical records, medical malpractice in Illinois, and joint ventures.

The lectures take place at the offices of Katten Muchin Rosenman, conveniently located near trains and parking at 525 West Monroe. Lectures start with refreshments at 8:00 AM and conclude by 9:45 AM.

Attendees can earn 1.25 hours of Illinois MCLE credit. Lectures are free for IAHA members and only $50 for non-members.

2019 IAHA Quarterly Meeting Dates are: 

March 7, June 27, September 19, and December 12


 

Mobile Health Apps and Other Health Software—What Does the FDA Regulate?  What Does It Not?

Mobile health apps and other health software play an important role in U.S. healthcare.  Healthcare professionals and medical institutions routinely use such technology in healthcare delivery.  Patients and other individuals increasingly use such products to manage their own medical conditions and wellness. 

This session will focus on the following questions, using hypotheticals to discuss key answers and bringing together the perspectives of law firm, industry and provider representatives:

• Under FDA law and policy, what types of mobile health apps and other health software does FDA actively regulate as a medical device?  What types does it not?

• What is the difference between an unregulated health “wellness” product claim and an FDA-regulated “medical device” claim?

• What FDA requirements apply to such products when regulated?

• Are healthcare professionals and medical institutions subject to FDA regulation if they create or modify such products?

 • What other legal issues arise from development and use of such products?

Special Offering - Join other IAHA members in Springfield to watch the presentation online. Simply sign up for the in-person registration and mark that you will be attending in Springfield.

 

Our Speakers:

Neil O’Flaherty is a Partner at Amin Talati Wasserman, LLP in Chicago and has over 28 years of legal experience in private practice..  He assists product manufacturers, distributors, healthcare institutions and professionals, and venture capital and private equity groups with U.S. Food and Drug Administration (FDA) medical device and other regulatory matters.  In addition, his work has included providing advice and counsel to a foreign governmental entity with respect to U.S. FDA regulatory matters.

In the FDA medical device space, Neil works with Class I, II and III products at any stage in their premarket or commercial lifecycle.  This work includes counseling and due diligence assessments on cutting-edge issues such as FDA’s evolving regulatory oversight and framework for digital health products (both general wellness and actively-regulated device products)   Neil has assisted numerous developers and marketers of mobile medical apps and other health software with both premarket launch and post-market FDA compliance issues.

Neil holds a J.D. from Loyola University Chicago School of Law and a B.A. from the University of Notre Dame.

 

Ann Ford is a Partner at Hall Prangle and Schoonveld, a national law firm with its primary office in Chicago. She concentrates her practice on healthcare law for hospitals, healthcare professionals, and medical device and pharmaceutical companies. Prior to HPS, Ann was the deputy general counsel and global compliance and privacy officer for Medline Industries, Inc., a large medical supply and device company. For several years before coming to Medline, Ann was General Counsel and Chief Compliance Officer for two hospitals in the Chicago area. As such, she was responsible for providing advice and counsel to the board and senior management on multiple issues, including transactions, litigation and regulatory matters. Prior to her in-house positions, Ann was a partner at a Chicago law firm and represented hospitals, physicians and other health care providers in litigation. She began her healthcare career as a nurse, working in critical care pediatric, neonatal and obstetric units. Ann has a B.S. in Nursing from Marquette University and a J.D. from DePaul College of Law.

 

Reagen Atwood is Associate General Counsel at Ann & Robert H. Lurie Children’s Hospital of Chicago, a pediatric academic medical center in Chicago (“Lurie Children’s”).  Lurie Children’s is the largest pediatric specialty provider in the region whose physicians are faculty of Northwestern University’s Feinberg School of Medicine.  Lurie Children’s has several affiliated organizations including physician practice plans employing pediatricians and pediatric subspecialists, a research enterprise (Stanley Manne Children’s Research Institute), a fundraising organization, a clinically integrated network, and Almost Home Kids, which operates two licensed facilities providing transitional and respite care to pediatric patients with medical complexities.  After graduation from University of Michigan Law School in 1997, Reagen was admitted to the Illinois bar and began practicing law at Foley & Lardner (formerly Hopkins & Sutter) in the corporate law department where her practice included regulatory and health law matters.  In 2005, she joined Lurie Children’s as Assistant General Counsel.  She is a member of the Illinois Association of Healthcare Attorneys and American Health Lawyers Association.  Her practice includes advising Lurie Children’s and its affiliated entities on a wide variety of healthcare business and operational issues, transactions, and regulatory matters.

 

Click here to register for the IN-PERSON presentation (in Chicago or Springfield)

Click here to register for the ONLINE presentation.

 

 

Click here to view recorded lectures.

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