Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights notable developments and guidance that health care providers, digital health companies and other health care industry stakeholders should navigate in

The General Data Protection Regulation (GDPR) was the biggest story of 2018 in the field of global privacy and data protection. The GDPR became enforceable in European Union Member States on May 25, 2018, significantly expanding the territorial reach of EU data protection law and introducing numerous changes that affected the way organizations globally process the personal data of their EU customers, employees and suppliers. These important changes required action by companies and institutions around the world. In almost six months after the GDPR’s effective date, organizations are still working on compliance—and will be for years to come.

Critical provisions

The GDPR applies to organizations inside and outside the EU. Organizations “established” inside the EU, essentially meaning a business or unit located in the EU, must comply with the GDPR if they process personal data in the context of that establishment. The GDPR also applies to organizations outside the EU that offer goods or services to, or monitor the behavior of, individuals located in the EU.

The GDPR uses other terms not familiar to US businesses but which need to be understood. Both “data controllers” and “data processors” have obligations under the GDPR, and data subjects can bring actions directly against either or both of those parties. A data controller is an organization that has control over and determines how and why to process data. A data controller is often, but not always, the organization that has the direct relationship with the data subject (the individual about whom the data pertains). A data processor is an organization that processes personal data on behalf of a data controller, typically a vendor or service provider. The GDPR defines “processing” to mean any operation or set of operations performed on personal data or on sets of personal data, whether or not by automated means (e.g., collection, recording, storage, alteration, use, disclosure and structuring).

The GDPR also broadly defines “personal data” as any information directly or indirectly relating to an identified or identifiable natural person, such as a name, identification number, location data, an online identifier, or one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person. Organizations in the US are used to a narrower definition of personal data, which typically includes information that, if breached, would put an individual at risk of identity theft or fraud and require notice (e.g., Social Security numbers, driver’s license numbers, and financial account, credit and debit card numbers).
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As Europe’s General Data Protection Regulation (GDPR) takes effect, companies around the world are racing to implement compliance measures. In parallel with the GDPR’s development, China’s new data protection framework has emerged over the past year and is in the final stages of implementing the remaining details. With similar and often overlapping obligations, full compliance with the GDPR and China’s data protection framework presents a significant new challenge for companies with operations in China.

Does the GDPR Apply to Companies in China?

The GDPR applies to the processing of personal data of people who are in the European Union, even for a controller or processor in China, where the processing of the data is related to:

  • The offering of goods or services to the data subjects in the European Union, regardless of whether a payment is required; or
  • The monitoring of people’s behavior in the European Union.

As a result, even if a Chinese company does not have any formal establishments in the European Union, the GDPR will nonetheless apply if it is conducting either of these two types of activities.

What Are the Requirements for Companies in China Subject to the GDPR?

The GDPR primarily focuses on two categories of entities: “controllers” and “processors.” These two types are similar to concepts in the Chinese rules.  “Controllers” are entities that, alone or jointly with others, determine the purposes and means of the processing of personal data. “Processors” are entities that carry out the processing of personal data on behalf of the controllers.

Key requirements for most controllers under the GDPR:
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The General Data Protection Regulation (GDPR) establishes protections for the privacy and security of personal data (Personal Data) about individuals in the European Union (EU) single market countries, and potentially affects the clinical and other scientific research activities of academic medical centers and other research organizations in the United States.

This On the Subject includes

Enforceable in all EU member states on 25 May 2018, the General Data Privacy Regulation will require action by organisations both inside and outside the European Union to ensure compliance with this far-reaching privacy legal framework. Compliance is even more urgent given that the GDPR provides for large penalties in cases of infringement. As some

On April 28, 2017, the Italian Data Privacy Authority published a Guide on the application of the new General Data Protection Regulation (GDPR). The Guide does not set out implementing rules of the GDPR but rather provides a summary of “what will remain the same” and “what will change” in the main six areas covered