Israeli Parliament Mulls Laws Regulating Big Data Health App Usage

In January 2017, the Ministry of Health in Israel has released a memo describing a new set of regulations for data governance in the health sector and to be carried out by stakeholders in the Israel's healthcare system. According to Israeli media sites, the “memo specifically referred to big data applications by third party entities, and outlined the cases that require patient notification and compliance, even when the data provided has been anonymized”.

According to reports, healthtech and healthcare companies collaborate to run a multitude of pilots and tests across the Israeli healthcare system at any given time. At least that was what a a senior executive at one of Israel’s public hospitals had told media site, Calcalist, on condition of anonymity. More often than not, the pilots are run by startups that collect and use the data to create new medical treatments and products or improve on existing ones.

In December 2017 the same media site reported how several Israeli hospitals have been conducting a pilot program which used AI software to assist in deciding whether patients should undergo surgery. However these patients were subjected to these tests without their knowledge. The software has been developed by a startup named MEDecide in Tel Aviv and has uses patient data that was anonymized.

Founded in 2015, the startup’s software uses anonymized patient data such as medical history, previous test results, the medications prescribed to the patient to recommend whether surgery should be performed or not, sometimes even advising different treatments or additional testing. According to MEDecide's founders, the software is intended to prevent unnecessary surgeries and reduce both risks and costs to patients, hospitals, and insurers.

Throughout 2017, the software has been used in pilot programs at several Israeli hospitals, but patients whose situation was evaluated were not informed. MEDecide's founders and Itzhak Braverman, the director of Hillel Yaffe Medical Center's Otolaryngology Department which was part of the pilot, stressed that the program was fully authorized by the Israeli Ministry of Health, though according to the same media site, a spokesman for the ministry had said it is not familiar with the company and is not sponsoring the pilot program. The pilot has also been approved by the hospitals' institutional review boards.

In a December 2017 interview with media site, Calcalist, Uri Maklev, chairman of the Israeli parliamentary Science and Technology Committee, had said he would be promoting relevant regulation. "It's inconceivable that a doctor won't explain to the patient-relevant processes," he said. "Today, the big companies know us better than we know ourselves," Maklev said.

In what has been called a “precedent” for the healthcare industry and for any company running AI software to gather user data without prior consent, the memo declares “that patients must give their consent before medical data that can be identifiable can be shared with third parties. The memo also states that the healthcare organization sharing the data will be held accountable for any misuse of the information”.

The memo had further recommended that healthcare companies could increase access to the health data shared within the organization and even outside the organization given it stands united with the ethical principles of medical confidentiality. The healthcare regulators hope that sharing information among healthcare organizations and researchers will increase quality of medical care and service and set forth “scientific breakthroughs and advance healthcare in both Israel and the world.”

The regulations will become effective as immediately as it was made public and is supposed to be an interim framework until further recommendations of a dedicated expert committee could be studied in depth. This committee has been tasked with studying the secondary uses of health data and providing recommendations for ending ambiguous clauses in the relevant regulations, policies and laws and to limit manipulation of loopholes. The report was submitted in late January 2018. One of the recommendations has been to treat privacy as an important factor while sharing medical information.