15 Jun Liability issues not seen as roadblock to healthcare technology advancements
Madison, Wis. — The increased use of clinical technologies in healthcare does not absolve physicians and other healthcare workers of liability for care decisions, particularly when technology vendors include strong sales contract disclaimers.
But as clinical healthcare technology developers market their products more directly to consumers, they will assume more liability for use of their devices, attendees of the recent Digital Healthcare Conference in Madison were told.
“If you market more directly to patients, you assume more risk,” says attorney Derek Stettner, a partner in the Milwaukee office of law firm Michael Best & Friedrich.
Stettner, a conference panelist, noted the increased consumer-oriented marketing of medical devices by industry giants such as Siemens and GE Healthcare.
“They do face some increased tort liability,” Stettner said. But the marketing, which often directs consumers to ask their doctors about use of a product, may also increase sales to the point that the increased cost of liability is covered, he added.
Such liability, however, forces product developers to incorporate a higher standard of reliability, Stettner added. And that reliability over the long run will lead to a greater comfort level — a greater acceptance of the use of technologies in healthcare, including acceptance in healthcare decision-making and a stronger embrace of electronic healthcare records.
Technology is just a tool
In the meantime, “the ultimate call, the final decision over the diagnosis and the proper course of action has to be made by the physician,” Stettner said, agreeing with other observers that use of information technologies on healthcare decision-making is akin to using textbooks. Both are tools that the healthcare worker gleans information from; the tools are not the final decision-makers. “If the technology product says `this is the thing to do,’ and it’s not the right thing to do, the doctor needs the knowledge to know the recommended course of action is wrong,” he added.
Stettner sees an expanding use of clinical technologies because of the reduced risk of error they can offer.
“In the long run, for the types of things we ask medical devices to do, they are much more accurate than a human,” he said, citing blood pressure devices as a simple example. “The automated devices will make fewer errors.”
Additionally, electronic healthcare records are seen as a way to provide caregivers with a more complete and accurate picture of a patient’s status and health history. The results of that, proponents say, will be better preventive medicine and fewer problems related to lack of information.
Comfort levels will grow
That will lead to a greater reliance on technologies, and a greater comfort level among users and patients, Stettner added.
The comfort level may come slower for medical technologies that make course-of-action decisions, even though the technology itself isn’t far off.
He likened it somewhat to airlines “We’ve reached the point where we could do away with airline pilots because the technology exists to fly the plane without pilots,” Stettner said. But society has not reached a comfort level of flying without pilots.
“Medical technologies are probably coming that will make diagnoses, but the human involvement will be there for many, many years,” Stettner observed. “It will take a long time to reach the level of comfort where humans are not involved in the decisions.”
Market, law, balance liability
The acceptable level and ownership of liability is balanced by market forces and government regulations, Stettner noted. The threat of tort liability holds product developers to a high standard, but the threat can’t be so high that new, innovative products will never be developed, be said.
In the meantime, product vendors are protecting themselves from liability via sales and licensing contracts — some of which “are so favorable to the vendor that they state, `you indemnify me, no matter what,'” Stettner said.
Vendor-buyer contracts are key
The contract clauses that relate to liability are extremely important for both parties; Digital Healthcare Conference attendees were told.
“Make sure your contracts are strong and clear,” he said. “The stronger they are and the better you understand them, the fewer problems and surprises you will have.”
Vendors should “use disclaimers and use them frequently if you want to avoid liability,” added attorney John A. Busch, another conference panelist and partner in Michael Best & Friedrich.
Conversely, buyers strive to narrow or place no limitations on vendor liability, added fellow Michael Best & Friedrich attorney and conference panelist Robert V. Petershack, who also urged broader and more long-term contracts “with solid warranties that cover the deliverables.”
While liability is a concern, it should not be a roadblock to technology adoption, Stettner says, especially since new products offer the hope of greater accuracy.
“Hospitals should not avoid technology simply because they think it will add to their liability,” he said. “I think technology will, in the long term, reduce errors and, thus, reduce liability overall.”