Decision support intervention systems are designed to enhance healthcare delivery by providing evidence-based, data-driven insights and recommendations, aiming to improve patient outcomes, reduce errors, and promote efficiency in healthcare settings. Now, with the introduction of AI into healthcare technology we have entered the realm of predictive-based alerts and recommendations. There is a world of difference between the two models and in a future post we will explore the uncharted territory that is presented by predictive AI in patient care.
Whether evidence- or predictive-based decision support is utilized there is a paramount need for total transparency so users of the technology have full knowledge access to the origins of the underlying algorithms and, in the case of predictive AI decision support, training data. Currently, ONC, through the Certification process, requires functionality to allow “bibliographic references” related to the origin of specific rules and subsequent alerts. Makes sense to me that providers need to know if the EHR they are using is employing rules based on actual clinical evidence or if Big Pharma was paying bribes to make sure their medication was being pushed under the guise of appropriate healthcare. I guess at this point it is a good time to review a worst-case scenario of healthcare, capitalism, and the intersection of decision support systems. If ever there was a case of a bargain with the devil, this is it. Enter the unholy criminal alliance of Practice Fusion and Purdue Pharma.
It is difficult to comprehend the felonious acts that took place during this horror show that included bribery as well as allowing Purdue Pharma’s marketing staff design clinical support rules that promoted the use of OxyContin. If there was ever a nightmare case scenario, this is it. Let me quote directly from the press release from the Department of Justice.
- “Practice Fusion, Inc. (Practice Fusion), a San Francisco-based health information technology developer, will pay $145 million to resolve criminal and civil investigations relating to its electronic health records (EHR) software, the Department of Justice announced today (1/27/20).”
- “As part of the criminal resolution, Practice Fusion admits that it solicited and received kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications.”
- “Practice Fusion’s conduct is abhorrent…The companies illegally conspired to allow the drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care, including the need for pain medication and prescription amounts.”
- “Practice Fusion allegedly permitted pharmaceutical companies to participate in designing the CDS alert, including selecting the guidelines used to develop the alerts, setting the criteria that would determine when a healthcare provider received an alert, and in some cases, even drafting the language used in the alert itself. The CDS alerts that Practice Fusion agreed to implement did not always reflect accepted medical standards.”
- “Practice Fusion solicited a payment of nearly $1 million from the opioid company to create a CDS alert that would cause doctors to prescribe more extended-release opioids. That payment was financed by the opioid company’s marketing department, and the CDS was designed with input from the marketing department.”
I guess we shouldn’t be too surprised that during the Federal investigation there were acts of criminal obstruction by the Director of National Accounts for Practice Fusion.
Again, from the Department of Justice:
- “…in 2015 and 2016 Mr. Mack was the Director of National Accounts for Practice Fusion, an electronic medical record (EMR) company. In that position, Mr. Mack was a principal point of contact between Practice Fusion and Purdue Pharma with regard to the subject of the investigations. Mr. Mack admitted deleting from his company-issued laptop hundreds of computer files relevant to the investigation, with the intent to obstruct the investigation by impairing the integrity and availability of those records.
- “On October 21, 2020, various components of the Department of Justice, including the United States Attorney’s Office for the District of Vermont, announced that Purdue Pharma had entered into a plea agreement by which Purdue Pharma would plead guilty to conspiring to violate the Anti-Kickback Statute relating to its arrangement with Practice Fusion, among other things. On November 24, 2020, Purdue Pharma pleaded guilty to its illegal conspiracy with Practice Fusion.”
If there are any worse examples of similar conduct in the healthcare technology industry I don’t want to know about it. Once upon a time, long ago, I knew some of the folks at Practice Fusion and found them to be reflective of the best elements in healthcare technology with a goal of raising the bar on patient treatment. I feel for them as this scandal developed and warped their reputations. Like the old man on the bench says, “It only takes a few bad apples to ruin the barrel.”
So, there you have it. The need for total transparency into the who and what is behind the automated and programmed healthcare decision technologies must be fully transparent. With the introduction of AI and predictive-based decision support functionality things just might get a whole lot murkier. Stay tuned for Part 2 of this series where we take a close look at potential consequences of this new technology and focus on possible solutions to limiting risk, whether intended and not.