As health care organizations across the globe look to conduct important clinical trials in regions such as the Asia-Pacific for a wide variety of ailments — and now most urgently COVID-19 — they need to make sure that health care data gathered from these trials meet the increasingly stringent privacy standards and regulations put in place by various countries in the region, including Russia, China and Australia. Health care organizations must learn to operate within each country’s specific data privacy laws to prevent hefty fines or, even worse, banishment from doing research or business in that country entirely.
COVID-19 has exposed the fact that drug companies have to accelerate drug development cycles to meet the urgent demand caused by the global pandemic. As scientists race to find treatments and a vaccine for COVID-19, the ability to store and process data globally takes on greater importance than ever before.
This piece focuses on the challenges health care organizations now face when it comes to handling global patient data that simply didn’t exist 10 years ago and how new cloud-based technology offerings can help health care organizations properly meet the onslaught of health data regulations while continuing to conduct clinical trials within the APAC region and beyond.
An increasingly global approach to clinical trials
In mid-March, the World Health Organization announced that it would launch a multinational clinical trial for potential COVID-19 therapies, part of an aggressive effort to jump-start the global search to treat those afflicted with the virus. Four key drugs or combinations that are already licensed and used for other illnesses will be tested, according to the WHO Director-General Tedros Adhanom Ghebreyesus.
This move by the WHO to sponsor the trial indicates that efforts in China alone to test these drugs may not have come up with enough data to indicate whether any were of use to prevent patients from developing severe disease or death. Accordingly, the aptly named SOLIDARITY trial has already gathered 10 participating countries, including Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand.
However, more and more countries are imposing regulations on the collection, management and storage of their citizens’ personal data. Data localization laws, in particular, are a growing challenge for international companies of all kinds and for health care organizations in the current crisis. From Australia to Vietnam, various governments now require companies to physically store their citizens’ data within the country of origin. These laws vary by specific country and are evolving every day.
APAC and its unique data localization challenges
So why focus on Russia, China and Australia for clinical trials? While they do offer advantages to researchers, they are also now among the most heavily regulated countries in the world.
The largest country on Earth, Russia has a population of 145 million but also has a centralized health care infrastructure that offers highly efficient patient recruitment and costs that are only 20% to 30% of those of western European and U.S. equivalents. With nearly 1.4 billion residents, China is the most populous country in the world and the second-largest pharmaceutical market, behind the U.S. Therefore, it’s increasingly essential to make both countries a key part of any clinical development strategy.
Yet, according to our recent analysis of country-specific data privacy and protection laws, with a particular emphasis on data residency, Russia and China top the list as the two most strictly regulated countries. With a history of strong centralized regulation, each territory has implemented stringent national policies to control the commercial availability, transfer and exchange of data.
IMAGE: Countries with health data residency regulations. (Source: InCountry)
For example, Russia’s Federal Law No. 242-FZ, which amended Federal Law No. 152-FZ on personal data, requires data operators to store and process the personal data of Russian citizens within Russia. Similarly, China’s Cybersecurity Law prohibits cross-border transfers of citizens’ medical information.
New cloud-based options for data localization
As we’ve seen, driven by the urgency of the COVID-19 crisis, multinational clinical trials are more important than ever before. But the diverse and highly specific requirements of each individual country’s data privacy and localization requirements pose significant barriers to compliance.
To address them, health care organizations must consider new cloud-based offerings, such as data residency-as-a-service, to help store and process data within many different sovereign countries, particularly in those with the most strict health data laws, such as Russia, China and Australia. Luckily, these health solutions are cost effective, fast to deploy and scalable.
These cloud-based platforms do not replace an organization’s own data store but add an additional local repository for specifically regulated data and synchronize the data across two data centers. In this way, multinational trials meet data residency requirements on a jurisdiction-by-jurisdiction basis without the need for massive investments in infrastructure, software or engineering talent.
And, most importantly, they are available today.
Photo by CDC on Unsplash
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