By Shelly Simana
On January 7, Israeli Prime Minister Benjamin Netanyahu announced that millions of vaccines are expected to arrive in Israel, and that by March, anyone who wishes to get vaccinated will be able to do so.
He concluded his speech with a controversial statement: “as part of the agreement [with Pfizer], we stipulated that Israel will serve as a global model state for a rapid vaccine rollout of an entire country… Israel will share with Pfizer, with all of humanity, the statistics that will help in developing strategies to defeat the coronavirus” (my translation, from Hebrew).
But which statistics, what kind of data, will be shared with Pfizer? This question remains a mystery.
It is known, however, that Israel’s health care system has vast and rich databases. These databases, which are maintained by the four health maintenance organizations (HMOs) that provide health services to every Israeli citizen, hold the medical records of more than 98 percent of the population. Within these databases are millions of health records that have been collected over a period of 20 years, which help provide a complete medical picture of each patient.
Thanks to the great heterogeneity in age and ethnicity of the Israeli population, these databases are immensely diverse. No wonder that they are considered a unique national strategic asset.
These databases are probably the reason why biotechnology companies are particularly interested in Israel, and why Pfizer agreed to a deal with Israel to expedite deliveries of its vaccine. Access to the information that is stored in the databases can provide biotechnology companies with a significant strategic advantage.
The agreements with Pfizer and with other biotechnology companies like Moderna have not been revealed to the public and there seems to be no plan to do so in the future. In addition, none of the people who have been vaccinated were required to sign a consent form for the release of medical information.
In his statement, Netanyahu used the word “statistics.” If that term is accurate, it is most likely that Israel will share aggregated data. Such data does not include identified medical information, and thus, the level of anonymity is higher. However, because there is no transparency regarding the details of the secret agreement with Pfizer, there is no guarantee that only aggregated data will be shared. Moreover, we must not forget that even sharing de-identified data can pose a serious risk to people’s privacy. The more medical information we share (such as chronic disease and age), the easier it may be to re-identify the data. And even if the data remains de-identified, the use of this data without individual consent may violate personal autonomy.
The possibility that Israel might share medical information with biotechnology companies raises an interesting dilemma — who “owns” the information? Is it “owned” by the individual, the HMOs that have invested resources in analyzing and processing the information, or perhaps the government that provides funding to the HMOs?
The question of ownership over medical information has not been determined by Israeli law. One may look at the Patient Rights Law for a clue. This law, which was passed in 1996, was not intended to regulate the proprietary aspect of medical information, yet it imposes on a caregiver or a director of a medical institution an obligation to maintain and preserve a person’s medical record. In other words, the caregiver or the institution holds practical control over the information. It is thus implied that they have a right to possess the medical records and the information contained therein.
Under this law, the patient only has a right to obtain and copy (for a fee) information from the medical record. One could argue that the caregiver’s or the institution’s practical control is an indication of their ownership over the information. Another interpretation could be that the record and the information it contains belong to the individual; the caregiver or the institution merely hold the information in trust and safeguards it.
Over the past few years, the Ministry of Health has dedicated time and effort to studying and understanding the implications of the use of medical information. As part of this effort, it appointed a public committee—the Committee for the Implementation of the Recommendations for Secondary Uses of Health Information—that released its recommendations in January 2018.
The members, however, could not reach a consensus on the issue of ownership over medical information and refrained from making decisions on this subject. In its report, the Committee noted that five possible entities could claim ownership rights over medical information: (1) the patient; (2) the caregiver; (3) the organization that employs the caregiver; (4) the public (or the state); and (5) various entities that assist in the collection and improvement of the information. The committee held that while identified information should be owned by the individual, it is not clear who owns the de-identified information, the aggregated information, and the databases.
There is not enough space in this post to discuss the complex question of ownership over medical information in depth. I do, however, want to advance the argument that countries, including Israel, should provide individuals more control over medical information.
In 1990, in Moore v. Regents of University of California, the Supreme Court of California dismissed plaintiff John Moore’s claim and held that individuals do not have a continuing right to control the use of their excised cells.
The court ruled that “to impose a tort duty on scientists to investigate the consensual pedigree of each human cell sample used in research … would affect medical research of importance to all of society.” The court seemed to believe that researchers must have free access to biological materials (and the information that can be derived from them).
This view was criticized by Justice Stanley Mosk in his dissent. In his dissenting opinion, Justice Mosk held that Moore had valuable property rights in his excised cells and that he “had the right to do with his own tissue whatever the defendants did with it: i.e., he could have contracted with researchers and pharmaceutical companies to develop and exploit the vast commercial potential of his tissue and its products.” Justice Mosk de facto considered Moore a “co-inventor.”
I find Justice Mosk’s dissenting opinion very intriguing. But one does not necessarily have to adopt his view in order to argue that individuals should have more control over medical information.
Individuals, I believe, should not only have free access to their own medical information; they should also have some control over the scope of their information that is being transmitted to third parties, the level of anonymization, and the manner in which the information is being used. This approach guarantees that the information is being used with the person’s consent, without violating his or her right to privacy (or property). Allowing an individual to control their medical information also fulfills their right to autonomy.
In order to allow more control over medical information, an ongoing engagement and communication mechanism between individuals and researchers should be implemented. Such a mechanism would allow a person to have continuing control over their medical information and enable him or her to provide ad hoc consent so that the information will not be used for a purpose or in a manner that is against the person’s conscience.
Only time will tell if this approach will ever be adopted in Israel. In the meantime, in the absence of clear rules, it seems that every HMO will be able to decide how to use the information, to whom this information can be provided, and in what format.
It also remains to be seen what kind of data was promised to Pfizer, and whether the HMOs will be forced by the Israeli government to share this information.