November 2, 2018 | Coding, Billing and Collection, Compliance, Legal and Medical Malpractice, Digital Pathology, Instruments and Equipment, Laboratory Instruments and Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Experiments Laboratory operations, laboratory pathology, laboratory testing, management and operations
Patient privacy, the ethics of monetizing non-profit data, and issues surrounding industry conflicts emerged after the public announcement of the arrangement to grant exclusive access to academic pathology slides and samples
The clinical laboratory and the anatomical pathology team have become the gatekeepers of a series of medical data used in the treatment of patients. Glass slides, paraffin-embedded tissue specimens, pathology reports, and autopsy records are of great value to researchers. The challenge is how pathologists (and others) in non-profit academic centers can potentially profit from their exclusive access to this archived pathological material.
Now, the recent collaboration between Memorial Sloan Kettering Cancer Center (MSK) and Paige.AI (the developer of artificial intelligence in pathology) demonstrates how academic pathology laboratories can achieve this goal, using decades of research and Development plays a similar gatekeeper role in research and development. The case is in their file.
However, this arrangement is not without controversy.
New York Times, ProPublica reports
According to investigations by the New York Times (NYT) and ProPublica, MSK pathologists and board members have been criticized by doctors and scientists for fear of ethics, exclusivity, and profit from data generated by doctors but owned by MSK.
"Hospital pathologists strongly opposed the Paige.AI transaction, saying that it was unfair for the founder to acquire equity in a company that relied on the expertise of pathologists and accumulated over 60 years of work. They also questioned the use of patients without their knowledge. Of data-even if anonymous-in profit-driven companies," the New York Times article pointed out.
As part of the report's strong opposition, well-known members of MSK are facing censorship from the media and peers-some of them have given up their shares in Paige.AI. This is an example of the dangers and public relations issues that laboratory stakeholders may face. These issues involve the security of data sharing and profitability of patient data used by medical laboratories and other diagnostic providers.
There is controversy surrounding the formation of the Paige.AI/MSK partnership
In February 2018, Paige.AI announced the completion of a US$25 million Series A financing transaction and obtained the exclusive right to use 25 million pathological slices and computational pathology intellectual property rights held by the Department of Pathology at the Sloan Kettering Memorial Hall. The TechCrunch report pointed out that although MSK acquired equity as part of the license agreement, they are not cash investors.
TechCrunch lists David Klimstra, MD, head of MSK's Department of Pathology (left) and Dr. Thomas Fuchs, director of Computational Pathology, MSK Warren Alpert Center for Digital and Computational Pathology (right), as co-founders of Paige.AI. (Photo credit: The New York Times/Thomas Fuchs Lab.)
According to STAT, the establishment of the company involved three internal hospital personnel and three additional board members, and the hospital itself was established as part of the owner.
The official, who asked not to be named, told the New York Times that MSK's board members only invested in Paige.AI after the early attempts to arouse outside interest and the failure of investors. The New York Times report also pointed out that experts in non-profit law and corporate governance have raised questions about compliance with federal and state laws governing non-profit organizations under Paige.AI transactions.
Increasing privacy implications and potential pitfalls of medical laboratories
The original New York Times report in September 2018 stated that Klimstra intends to divest his ownership of Paige.AI. The New York Times pointed out in a follow-up report in October that Michigan Democratic Rep. Debbie Dingle submitted a letter questioning patient privacy details related to Paige.AI's access to MSK's academic pathology resources.
As patient data continues to populate electronic health record (EHR) systems and research and commercial databases, privacy remains the focus of media and regulatory review. The Dark Daily recently reported how researchers at the University of Melbourne proved how easy it is for malicious parties to re-identify data that has already been identified. (See "Researchers easily re-identify patient records that have been identified with 95% accuracy; Patient test records privacy protection for clinical laboratories concerned", October 10, 2018.)
According to the New York Times, MSK also issued a memo to employees announcing new restrictions on interaction with for-profit companies and suspending board members from investing in startups or holding board positions in startups created within MSK. The non-profit organization further stated that it is considering prohibiting hospital executives from getting paid for their work on external boards.
However, MSK told the New York Times that this only applies to new deals and will not affect the exclusive deal between Paige.AI and MSK.
"We have decided," MSK wrote, "when profits are generated through monetization of our research, the funds paid to MSK's designated board members should be used for the benefit of the agency."
There are currently no official legal documents regarding litigation against partnerships. Nonetheless, the arrangement — and its subsequent impact after its announcement — has become an example of the pitfalls that medical laboratories and other medical service centers considering similar arrangements may face in terms of public relations and employee reviews.
The risks and rewards of pathology data monetization
Although the situation of Paige.AI is just one of the many concerns currently facing the MSK medical team and board members, these incidents are an example of the risks that pathologists face when they play a role in a commercial enterprise outside of their business or department.
In doing so, pathologists invested and formulated a deal with Paige.AI, which brought criticism from reputable sources and negative exposure from major media to their business, themselves, and MSK as a whole. The lesson of this incident is that pathologists should exercise caution when receiving access to patient materials and data archived by their respective anatomical pathology and clinical laboratory organizations.
Sloan Kettering's warm deal with startups sparked new commotion
Paige.AI received US$25 million and signed an intellectual property agreement with Sloan Kettering to introduce machine learning to cancer pathology
Sloan Kettering executives change hands on unexpected equity in biotech startups
The chair of the cancer center's board of directors accuses top doctors on the issue of "crossing lines"
In memory of Sloan Kettering, you betrayed my trust
LVHN patient data is not shared with for-profit companies in the Sloan Kettering trial
Researchers easily re-identify patient records that have been identified with 95% accuracy; the privacy protection of patient test records is a concern of clinical laboratories
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