From: Healthcare Innovation
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Anne Petterd, Principal, Baker McKenzie Wong & Leow: In terms of data sovereignty – where a jurisdiction places restrictions on taking data beyond its borders – healthcare data is an issue which comes up frequently when parties are trying to negotiate free trade agreements. There’s a notion that if the data is within the country, it may be more accessible to those who need it, be it the patients or the healthcare providers. There’s also the notion among regulators that if the data is within the country, it may be more secure. However, if you speak to the cloud providers, particularly those who spend a lot of time investing in security for their products, this may be one of the main issues that they want to discuss with regulators as to whether that is really true. Companies may want to deliver services from one central location for efficiencies across borders, and with that come savings in terms of time and storage of data, especially when it comes to big data analytics. This is an issue that healthcare companies may feel is constraining them with what they want to do in the region.
Isabella Liu, Head of Asia Pacific Healthcare, Baker McKenzie: Coming to the use of data – many medical devices now incorporate the use of electronic data. The China Food and Drug Administration has issued guidelines that cover the handling of this data, which state that measures must be in place to ensure the security of data but there are no mandatory rules governing what measures have to be put in place. Hence, they are relying on the product owner to ensure the proper usage of the data. However, if the companies do not provide information as to how they go about resolving the cybersecurity issues, there be may delays in the product registration.
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