Article by Terry R. Knapp, MD
This is truly a golden age of innovation and technological success in medicine. We can define and catalogue the genetic blueprint of the individual patient. We can replace hearts, and corneas, and livers, and lungs, and more. We can install an artificial pancreas that uses microelectronics to meter and infuse insulin as metabolic requirements change throughout the course of a diabetic’s day. We can cure cancers by wiping out the entire immune system, and then replacing it. Why, we can actually go far beyond prolonging life—we can, and do, prolong death. We can also violate patient privacy without patient knowledge. We can exploit the economic basis of health care delivery by recommending tests, treatments and interventions with marginal, or even negative, individual benefit. And we tend to justify it all based on obeisance to innovation and technology.
The stark truth that constitutes the ugly underbelly of technology and innovation is that we have failed to reconcile technological advances with the social contract between the individual patient and the health care industry. My ninety-year-old mother-in-law has late-stage Alzheimer’s disease. In a mirror, she does not recognize the person looking back at her. This spring, she had a small lump in her breast diagnosed on excisional biopsy (local anesthesia, outpatient) as low grade carcinoma. The recommendation: modified radical mastectomy with consideration of follow-up chemo and/or radiation therapy. The decision: No thanks. The conclusion: the physician made a recommendation whereby technology triumphs over common sense. Sometimes we seem to forget that life, after all, is a finite condition.
Just what responsibilities to the social contract do we in health care have? How can we close the gap between those responsibilities and the rapid advancements in technology that seem to erode the ethics of what we do day by day? Is technology really the culprit, or is it perhaps part of the solution?
First, let’s take a look at the elements of the social contract that are under assault in health care. The operative word is “contract.” When we assume the care of a patient, we, the professionals, create a legal relationship with the layperson, the patient. We contract to provide a service in exchange for remuneration. That service nearly always entails both putative benefit and real risk. Some of the elements of the contract include attention to:
- The right of patients to know and understand the risks, benefits and alternatives of
- any recommended treatment, therapy or intervention;
- any recommended drug or medical device used in treatment, therapy or intervention;
- The right of patients to exercise control over the disclosure and uses of information about
- The right of patients to know and understand the risks, potential benefits, and intellectual
property issues when they donate tissues or organs;
- The right of patients to know and understand the implications of the factors inherent in
medical durable power-of-attorney;
- The right of patients and blood relatives to know and understand the risks and potential
benefits of genetic patient profiling; and
- With appropriate understanding and knowledge of all these issues, the right of patients to give
un-coerced permission to proceed, or to refuse that permission without prejudice toward
Privacy, informed consent, property rights associated with genetic information or tissues and organs, choosing death rather than submitting to extraordinary measures—all these are elements of the social and legal contract between the health care professional and the layperson. The breadth of the gap between the actual contract and the exercise of technology designed to fulfill the contract constitutes the playing field for the plaintiff’s attorney. Today, it’s a big playing field. The increase in malpractice litigation, privacy litigation, product liability litigation and myriad other health care litigation is prima facie evidence of that gap. How can we close it?
Technology and innovation cannot and must not be stopped, much less reversed. The solution must be the application of technology specifically directed at accommodating the social contract. However, there must be more than just technology. Technology should be employed to underpin the process of respecting the social contract. Any entity assuming this technology-based task must structure and manage the contracts in health care, create audit trails to demonstrate compliance, and must be held accountable by all stakeholders in the equation. Let’s call this entity a “trusted infomediary.” Here is a partial list of its duties:
- Create an electronic “middleware” platform for the secure, auditable exchange and storage of
health care information.
- Create and manage the electronic means for doctors to educate patients, establish a response
mechanism to questions and concerns, document the layperson’s understanding of the issues,
archive the session and provide for legal sign-off to the decision.
- Create and manage the means to hold electronic proxy to the patient’s authorizations,
however varied, for the myriad disclosures and uses of personal health information, and be
able to log all instances of such use in auditable form.
- Offer the electronic means to connect all stakeholders in health care and be suitably
accountable to each and every one.
One can debate, were such an entity to exist, that it be privately or publicly held, government or private sector managed, and so forth. That aside, imagine the checks and balances, streamlining and efficiencies, quality assurance mechanisms and best practices applications that might thrive in such an environment. A trusted infomediary as described could support disease and wellness applications, confidential e-commerce in health care, the end-to-end process of informed consent for everything from genomics privacy to anesthesia consent, as well as secure and confidential error reporting and QA-QC initiatives.
This vision of reconciliation between the social contract and technological advances is on the path to realization. Several companies, including my own, are working hard—not to put the tech genie back in the bottle, but to give her the social contract companion that she badly needs.
Dr. Terry R. Knapp is CareSpan’s Chief Medical Officer. He is a Stanford-trained, U.S. board-certified surgeon with a 40-year history of multinational care delivery. He is an accomplished medical device and medical services entrepreneur and corporate executive, co-founder of Collagen Corporation, and several other private and public companies, and has served in numerous executive roles and Board of Director positions. more