We sat down with Art Papier MD, CEO of Visual Dx and Kevin Larsen MD, SVP of Clinical Innovation at Optum to discuss technology's role in enabling the next generation of clinical decision-making. We learned a lot during the conversation that you can read about here. Those in attendance raised a lot of interesting questions, more than we were able to discuss during the one-hour panel. Questions that we didn't get to during the panel, Kevin and Art have answered here and we've also added the perspectives of our research team.
Q: When is decision support considered to be a clinical device as opposed to information?
Kevin Larsen: This is complicated, and I am not giving legal advice, but basically if the clinician can "independently review the basis of the recommendation" then the FDA does not consider the CDS a CDS Software Device. The FDA offers guidance here.
Art Papier: I would say when software makes claims it is diagnostic and the vendor is saying it has a percent accuracy for diagnosis, it is definitely a device. On the other side when the software is intended as a reference to augment medical thinking, is not claimed to be diagnostic and is tied to the medical literature then I believe it is not considered a device.
Q: Are virtual primary care efforts doing the right thing by just replicating current workflows?
Larsen: Almost certainly not. Think of the difference between brick-and-mortar retail and online retail, or brick-and-mortar banking and online banking. Our experience with other virtual services that were once in person is vastly different than the in-person experience. I expect great innovation here but cannot predict just what will emerge. Just like I couldn't predict Amazon online shopping when I was first using the WWW in the mid-90s.
Papier: It is difficult or honestly impossible to perform a complete physical exam virtually. Most virtual primary care visits target simple problems. The opportunity is to engage more with the patient through intelligent questionnaires. Industry is still scratching the surface of what a virtual workflow can be.
Research team: As many of us have experienced over the past few years, innovation tends to replicate what exists as people grow comfortable and realize what new possibilities it can create. The utility and success of future clinical decision support in primary care will depend on striking a delicate balance between integrating into traditional models and innovating new and better ways of delivering patient care in a virtual setting.
Q: Do you feel there will come a time where we rely too much on technology and lose those foundational skills?
Larsen: As a medical educator, I have thought about this a lot. The question is, what is the risk when we lose those fundamental skills? For example, kids now routinely are allowed to use calculators on algebra and calculus tests. They are not proficient in long division or slide rule skills, what risk does this pose? They have computers and calculators everywhere.
Similarly, I have lost my skill at percussion (tapping on a chest or belly to hear sounds and determine what is underneath). I now use an ultrasound instead. What risk is this? My elderly mother routinely uses a backup camera on her car- she has lost her skill at backing up without a camera is this an important skill for her to retain? The answer to all of these in my mind is research shows we are safer and more accurate with these tools than without. I will always vote for safety and reliability. As a wise medical teacher once told me, "There is no such thing as cheating in medicine. Any way you can make the right diagnosis and find out the information is legitimate."
Papier: Completely agree with Kevin. One point is you can use technology and preserve clinical reasoning skills simultaneously. They are not mutually exclusive. Technology can be developed that both improves care and clinical reasoning at the same time.
Research team: The potential benefit of technology-assisted clinical practice outweighs the potential risks associated with this advancement, and even more so those associated with not advancing. There is a desire, from both clinicians waiting to enter the workforce and those actively practicing, to see more technology integrated into training. There are many ways this can occur, but we recently spoke with a physician-innovator who made the interesting proposition that medical education should incorporate a health technology start up rotation in addition to the classic specialty rotations we have now.
The goal here would be for medical students to have a hand in practical projects where they are able to see firsthand inventive clinical applications of technology and how technology can be implemented to improve patient care. That way, innovation is incorporated into their education as part of their foundational skills rather than an afterthought.
Q: How can clinical decision support improve the growing challenges of mental health?
Larsen: We are doing several projects to support providers in treating mental health concerns. Dr. David Mohr has a career of terrific research in this space. Check his work out: https://cbits.northwestern.edu/areas-of-focus/index.html
Papier: Research shows that people with emotional or psychological problems feel that interacting with a computer is felt to be non-judgmental. I think there needs to be more research as there is a great need with the shortage of mental health professionals.
Research team: Evidence-based care is not always applied consistently in the mental health field, for a variety of reasons: the clinicians making treatment decisions may have limited training in mental health or be unaware of the evidence base; the evidence base for mental health treatment relies on more qualitative metrics than other medical conditions; and there's less investment in measuring behavioral health interventions compared to physical health. There's an opportunity to use CDS to address some of these barriers to consistency and guide clinicians toward the most effective treatment options. I hope that as CDS for mental health evolves, it incorporates holistic treatment options—not solely medication but also evidence-based supports like therapy and addressing underlying social needs.