Apart from natural gas, Israel doesn’t have a lot of natural resources: no oil, no gold, no iron ore and no magnesium. But it does have one resource that has become the gold of the 21st century: information – in particular, the kind that is both especially valuable but especially sensitive – a huge database on the health of the population.
The database is a resource that has been collected, documented, nurtured and maintained with exceptional care and skill for decades. From simple blood tests to MRIs, from records of patients complaining to their family doctor about pain to results of advanced surgery, from birth to death – everything is centrally stored by the Israeli healthcare system.
Haaretz Weekly Ep. 58
In the emerging era of artificial intelligence and personalized medicine, high-quality big data on millions of people is an invaluable resource. And in addition to the clinical data that already exists, the government is also funding the launch of a giant genetic database called Pasifas (“Mosaic” in Hebrew) that will contain blood samples for more than 100,000 Israeli citizens, collected from health maintenance organizations.
Together with their existing health data, it will be used to develop personalized medicine, create tools for identifying and preventing disease and improve existing drugs, among other things.
Israeli health data is especially valuable in the global context. The country’s health system is very centralized, with just four big HMOs. And no less important, the Israeli system has been a global pioneer in medical information computing, so information is not only concentrated, but goes back many years.
Another advantage of Israeli databases is ethnic diversity. Because the society is so heterogeneous and includes people from a variety of communities and religious groups, its genetic and medical repository interesting, diverse and broad.
However, like any valuable resource, there are disagreements over how it will be allocated and by whom – in other words, how will regulations determine what businesses, healthcare providers and academic researchers are permitted to do with our medical data.
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Walking a fine line
The rules will have to walk a fine line between the ability to greatly improve medical care and bring billions of badly needed shekels into the healthcare system and concerns about medical privacy and the public’s property rights to the information taken from patients. In many ways, the debate underway – though for now under the radar – mirrors the one a few years ago over natural gas.
Two years ago, the government made a historic decision in approving a 922 million shekel ($267 million) nationwide program to make health data about the population available to researchers and private companies over five years. It aimed to boost research into digital health, turn the Israeli healthcare system into a world leader and make digital health into an important local industry and driver of economic growth.
The money allocated to the plan would be used to upgrade computer systems, improve medical records and develop the Mosaic genetic database.
Without question, Israel was latching on to a global trend in a big way. The digital medicine sector is growing rapidly. In 2018, it was valued at $86 billion globally; according to Global Market Insight, a market research firm, that figure is expected to reach $504 billion by the middle of this decade – a six-fold increase over seven years. By comparison, the global market for drugs will grow 1.1 times to $1.25 trillion over the same period.
“We’re at a critical crossroad,” said Nadav Caspi, an economist who prepared a study for the Tel Aviv-based Institute for Structural Reforms. “It’s not just that the market is forecast to grow at such a dizzying pace in the coming years. It will also be the sector that controls all the information and critical junctions in the healthcare system.”
Draft regulations that were 18 months in preparation by the Health Ministry are supposed to put order into the Israeli database. Before that, a government committee comprising officials from the healthcare system and representatives of the public examined the public’s attitudes toward the undertaking.
“From this sharing process, it emerged that the public trusts the healthcare organizations and is ready to let them conduct research with its medical data – but that it also wants to know exactly what researchers at these organizations are doing, so that nothing happens behind their backs,” said Esti Shelly, the Health Ministry official in charge of digital health. This job that didn’t exist a few years ago, but today it is the focal point of the country’s healthcare system. “I think this attitude is reflected in the draft regulations,” she added.
These regulations have been circulated to the relevant key players for review and comment, and about 50 have come back with comments already. Some say the regulations are too lenient and could jeopardize the public interest, both in terms of privacy and medical confidentiality and in terms of sharing future profits from the use of the database. Others have criticized the draft from the other direction, saying the privacy protections will make it too difficult to conduct research.
Shelly is taking all this in stride. “To me, the dozens of written and in-depth responses we’ve received for the draft are an incredible expression of confidence in the process. We do it with the intention of listening and making sure we haven’t missed anything,” she said.
The ministry is now reviewing the comments with the aim of preparing a final draft.
The draft regulations center on approvals to use healthcare data for research. They are similar to the ones that now exist to conduct medical trials on humans, delineated in the Declaration of Helsinki principles with additional safeguards for preserving confidentiality for both the patient and the data.
As with Helsinki, each institution will form a committee to oversee approvals for research, including what kind of data will be used, how it will be anonymized to protect privacy, who will have access to it and the ability of the researcher to ensure the standards are kept. The panels will be comprised of experts in medicine, data, privacy, information security and ethics. A nationwide committee in the Health Ministry will examine the most complex applications.
The regulations will allow researchers to use medical data that directly or indirectly relate to a person’s health, including mental health and behaviors that might impact health, such as exercise, smoking, diet and other lifestyle choices.
Researchers wanting to use the data have to show that it will employed for “worthy purposes,” meaning that it will be used to improve healthcare outcomes or services or human knowledge in the field of medicine. Even then, the researcher has to demonstrate that the benefits will outweigh any risk to privacy.
Any research that involves transferring information that identifies the person involved or could be used to infer his or her identity to a third party can only be used with the person’s expressed permission. Other data will be given to third parties only after it has gone through an anonymization process. Even then, a person can opt out of the process and not let his or her data be used.
The regulations bar the data from leaving the State of Israel. The Health Ministry director general will have the power to veto any committee decision or impose stricter conditions for using the data.
Until the regulations are completed, the legal status of the data is unclear. In theory, a healthcare organization can decide on its own policies on privacy and other issues. But far from creating a regulatory jungle, says one source who asked not to be identified, health organizations have been especially cautious.
“It is precisely this state of mind that had made organizations more concerned and more cautious – and this is actually hindering developments in the field,” he said.