Friday, October 29, 2010

In Memoriam, Bob Waters

The telemedicine community suffered a loss this week with the passing of Robert J. Waters, JD, the founder of the Center for Telehealth and eHealth Law and a long-time leader in telemedicine. He was diagnosed with brain cancer some time ago and died peacefully on Wednesday at home with his family.

His dedication to the field and his contributions to moving telemedicine forward were enormous. When ATA was founded in 1993, Bob was one on the first people I talked to in Washington, DC about telemedicine. His knowledge and expertise of legal and legislative matters related to telemedicine never ceased to amaze me. Bob established the Center shortly after the creation of ATA and has served as a major resource for health care providers, for leaders in Washington and for ATA regarding the many legal and regulatory issues confronting the expansion of telemedicine.

Bob served for four years as a member of the board of the American Telemedicine Association. In 2005, he received the ATA’s Leadership Award for the Advancement of Telemedicine and he was among those named as an ATA Fellow in the inaugural class in 2009. Bob played an instrumental role in the development of the Interstate Nurse Licensure Compact and received the National Council of State Boards of Nursing Exceptional Achievement Award for this work in 2004.

Bob’s passing is a great loss to telemedicine, a loss to ATA and a loss to his many friends and family. I will miss his passion, his deep intellectual insight and his ability to help make the world a better place.

In lieu of flowers, the family suggests that memorial gifts be made to: The Preston Robert Tisch Brain Tumor Center at Duke (c/o Ellen P. Stainback, Box 3624 DUMC, Durham, NC 27710); The Iowa State University Foundation – Robert J. Waters Memorial Fund (2505 University Blvd., Ames, Iowa 50010); or St. Peter's Episcopal Church (4250 N. Glebe Road, Arlington, VA 22207).

For those wishing to send Bob’s family a note or card, please send those to Bob’s wife: Patty Beneke, 1604 Crestwood Lane, McLean, VA 22101. Bob's family and Drinker Biddle would like to invite all his coworkers, colleagues, and friends to a memorial reception to celebrate his life on Tuesday, November 16, 2010 from 4:00 - 6:00 pm with details regarding location to follow.

Tuesday, October 5, 2010

FDA is Not the Bogeyman

There has been a lot of talk and, frankly, a lot of uninformed fear about possible forthcoming regulations from the U.S. Food and Drug Administration (FDA). As FDA explores its role in the changing world of health technology there has been a lot of talk about how the agency may require certification of every cell phone or every laptop that may be used in some way for provide medical assistance. Fears that FDA regulation may cause innovation in healthcare technology to come to a standstill are just plain silly. Medical devices that are used in providing healthcare to an individual are, and should be, regulated.

Over the past couple of years a lot of entrepreneurs have looked at the growth of healthcare costs, now above a trillion dollars a year, and decided to try and get a piece of the action. Many have decided to jump into the telemedicine market. An especially attractive part of telemedicine is mHealth with low entry requirements to create a new application for a digital phone. This Spring ATA sponsored a webcast with mobihealthnews where they reported on a recent survey that identified over 6,000 applications for health and wellness for digital phones. My guess is that the number is probably over 7,000 by now.

This is a welcome development and a great sign of progress but the new entrants need to understand the realities of healthcare and medicine. It is naive to assume that medical devices will not be regulated. It is not the same as creating a new video game.

I don’t believe increased scrutiny by FDA of health applications will appreciably slow development of the quality devices and applications that will really impact the delivery of health care. In fact, regulatory approval will help gain public and clinical acceptance of these new innovations as FDA approval implies a stamp of approval. However, it will slow down those with innovations that may not be appropriate.