Three recent developments have highlighted how difficult it is to predict when and if disruptive technologies will transform clinical medicine in the United States. That we are undergoing an avalanche of new information and new technology is hardly newsworthy. From the dawn of civilization to 2003, human beings created 1 billion gigabytes of new information. In 2012, Google says they catalog 2 billion gigabytes of information every two days.
One of the confounding factors on how this new knowledge and technology is adopted by an industry like health care is the law. Henry Perritt, Jr. describes two ways to think about the relationship between the law and technology. Technological change is “a major source of human problems that the law must address.” The law also always lags technology because the common law tradition requires “that the legal system should not predetermine the course of technological application and product development.” http://jolt.law.harvard.edu/articles/pdf/v10/10HarvJLTech689.pdf
The first example of this concept of the law lagging technology involves American citizen Ellie Lavi who underwent in vitro fertilization and the subsequent birth of twins in Israel. When she went to the American Embassy, she was told that her children would not be American citizens unless she could prove that either the egg or sperm used in her case came from an American citizen. “The problem is that the law hasn’t kept up with the advances in reproductive technology,” states Lawyer Melissa Brissman. http://www.usatoday.com/news/world/story/2012-03-19/in-vitro-citizenship/53656616/1
Recently the Supreme Court heard arguments in another case, which illustrates how the laws lag technology. Karen Capato gave birth to twins 18 months after her husband died of esophageal cancer by using his sperm that had been frozen and banked before his death. The federal government denied her twins’ claim for Social Security survivor benefits, and she appealed to the Supreme Court. The justices really grappled with the problems of trying to figure out how to rule based on a 1930s federal law that never anticipated such technological advances. “You want us to sort of apply this old law to new technology,” observed Justice Stephen Breyer. Many of the justices worried about all sorts of scenarios: the wife remarrying, the complexity of state laws with different rules on benefits, and others. They have yet to decide this case.
Yesterday, the Supreme Court ruled in favor of the Mayo Clinic and against patent protection for a biotechnology company named Prometheus Laboratories who had patented a test to calibrate drug doses of thiopurine to treat Crohn’s Disease and ulcerative colitis. http://online.wsj.com/article/SB10001424052702304724404577293390828369720.html Writing for the court, Justice Breyer “said natural laws may not be patented standing alone or in connection with processes that involve ‘well-understood, routine, conventional activity.’” This ruling may delay the implementation of personalized medicine, which touts being able to individualize the doses of drugs based on the patient’s genetics. Just before oral arguments at the Supreme Court, Prometheus was sold to Nestle, and Justice Breyer’s wife owned stock in that company. She sold the stock on the morning of the hearing so that Breyer would not have to recuse himself from the case. http://www.nytimes.com/2012/03/21/business/justices-reject-patents-for-medical-tests-relying-on-drug-dosages.html
These three examples that I read about in less than a month’s time highlight how the law always lags behind technology. Pundits, myself included, who write about how personalized medicine and digital technologies will transform medicine, must take into account the inability of the common law to rapidly adjust to new situations. We usually underestimate the eventual effect of disruptive technologies and overestimate how fast they will be adopted.
Kent Bottles, MD, is past-Vice President and Chief Medical Officer of Iowa Health System (a $2 billionhealth care organization with 23 hospitals). He was responsible for the day-to-day operations of a large education and research organization in Michigan prior to his work with in Iowa with IHS. Kent posts frequently at his blog, Kent Bottles Private Views.