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Data Protection During and After the Pandemic: Consolidate, Update and Innovate

Having adapted products, processes, services, facilities and IT systems in response to Coronavirus (COVID-19), businesses should now refocus on their legal and business fundamentals as they move towards returning to the office. Compliance policies should be updated, Brexit contingency plans reinvigorated, and upcoming legal and regulatory changes anticipated.

While taking these steps, businesses should bear in mind a number of key data protection and IT/cybersecurity fundamentals, and take the opportunities afforded by the return to work period to kick-start new initiatives.

Click here to read the full article, and many more in our latest International News: Focus on Global Privacy and Cybersecurity.

 




Health Care Data Compliance in China: 4 Key Questions and Compliance Steps for Multinationals

This post was guest authored by lawyers from MWE China Law Offices, McDermott Will & Emery’s strategic alliance in Shanghai. 

Data compliance in China’s health care industry is multifaceted and highly sensitive, and applies to numerous types of data generated across the continuum of care. Multiple pieces of legislation prescribe complex regulatory requirements governing different types of data, and various supervisory authorities frequently conduct inspections and investigations, paying special attention to health care multinationals with operations in China.

This article explores four key questions on the regulatory requirements for health care data in China, along with key compliance steps for multinationals throughout the entire life cycle of health care data, including collection, storage, transfer and use.

1. What types of health care data are regulated in China? What are the key compliance points related to these types of health care data?

Data compliance rules apply to various sources and types of health care data, including medical record information, medical insurance information, health care logs, human genetic resources, medical experiments and scientific data. The table below lists the various types of health care data governed by China’s laws and regulations related to health care and personal information, as well as the key regulatory compliance focus for each category.

Category Definition Key Regulatory Compliance Focus

Health Care Big Data

The Administrative Measures on Standards, Security and Services of National Healthcare Big Data (for Trial Implementation)

Data relating to health care generated in the course of disease prevention and control as well as health management

Note: the Measures do not clarify what data qualifies as health care “big” data.

Localisation and storage

Transfer: Cross-border data transfer is subject to security assessment.

Human Genetic Resources

The Interim Administrative Measures for the Management of Human Genetic Resources Genetic materials and related information, including organs, tissues, cells, blood, preparations, recombinant deoxyribonucleic acid (DNA) constructs containing human genome, genes and their products.

Collection: Complex approval procedures are required, and collection by foreign entities or individuals is restricted.

Localisation and storage

Transfer: Approval from administrative bodies is required before cross-border transfer.

Pharmaceutical Data

The Pharmaceutical Data Management Specification (Draft for Comments) Data from all activities in a product’s life cycle, such as R&D, production, circulation, post-marketing monitoring and evaluation. Laws and regulations on personal information protection, health care big data protection and human genetic information protection, etc., may apply under certain circumstances.

Medical Device Data

The Guidelines for Technical Review of Network Security Registration for Medical Devices Health care data and device data. Laws and regulations on personal information protection, health care big data protection and human genetic information protection, etc., may apply under certain circumstances.

Medical Records

The Regulations for Medical Institutions on Medical Records Management

All texts, symbols, graphics, images and slides produced in medical activities by medical personnel, including outpatient (emergency) and hospitalisation medical records.

Medical records are filed as medical history.

Collection: Consent from data subject is required.

Transfer: Medical institutions should keep records strictly confidential except under specific circumstances.

Scientific Data

The Measures for the [...]

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China Data Protection Enforcement Update – A Focus on Platform Content

Following the first enforcement actions by local authorities in Shantou and Chongqing for violations of the new Network Security Law that came into effect this year, authorities in China have recently shown a clear initial focus with several new cases targeting provisions of the law that require monitoring of platform content. As of the start of October 2017, enforcement actions by authorities in China have targeted platform content violations in nearly 70 percent of all actions under the new provisions of the data protection rules.

 

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China’s Network Security Law Comes into Effect: What It Means for Your Company

Today, China’s much anticipated Network Security Law comes into effect after two years of review, revisions over three drafts and a public commenting process. The law is a historical development for China’s legislative coverage of information security and data protections. It also represents one of the strictest approaches in any jurisdiction worldwide, and a continuation of a broader effort at demonstrating the government’s cyber-sovereignty goals through control and regulation of data and the internet.

Overview of the Network Security Law

Commonly referred to as the “Cybersecurity Law,” the new piece of legislation has a broad scope and covers a range of issues related to data privacy, security and cross-border transfers, including:

  • Increasing security measures and strengthening data security through a variety of specific obligations
  • Ensuring consent for collection of personal information through the principles of legality, proper justification and necessity
  • Screening equipment and products for security testing and certification
  • Ensuring real-name registration for users
  • Strengthening requirements to cooperate with government agencies during criminal investigations or to protect national security
  • Requiring personal information to be stored in China under some circumstances
  • Increasing confidentiality measures for user information
  • Setting up a complaint and reporting platform for network security

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