The European Commission (EC) recently issued online guidance on the General Data Protection Regulation (GDPR), a sweeping European Union (EU) data protection legislation that will take effect on May 25, 2018. The guidance is intended to be used as a tool to help businesses as well as the EC, national data protection authorities, EU Member States, and other national administrations prepare for the GDPR. To date, only 2 EU Member States – Germany and Austria – have adopted the relevant national legislation to be in compliance with GDPR.
Category: Privacy
Information Injury Workshop Covers Non-Financial Harms Faced By Consumers
The Federal Trade Commission held its Information Injury Workshop in December in Washington D.C. The goal of the workshop was to explore how to characterize and measure information injuries to consumers.
Information injury is the harm that a victim suffers as a result of privacy or data security breach. Financial, health and safety injury are the most common types of alleged injuries that the FTC has seen in privacy and data security in the past few years. Yet, injury that does not cause financial harm can be challenging to quantify.
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FDA Approves Software Application That Alerts Providers of Potential Stroke in Patients
On February 13, 2018 FDA approved a software application with clinical-decision support capability, in this case alerting providers of a potential stroke in patients. The system, “Viz.AI Contact,” is developed by a US/Israeli company named Viz.ai, which uses artificial intelligence and machine deep learning for analyzing medical images. Earlier in January, this system also received a CE Mark from the European authorities.
Stroke is caused by an interrupted blood supply to the brain; for example, due to a blood vessel’s rupture. Stroke is among leading causes of mortality and long-term disability in the U.S. and other countries. The Viz.AI Contact system analyzes brain computed tomography (CT) scans, identifies a suspected large vessel blockage, and sends a text notification to the health care specialist.
Involuntary Dissolution Does Not Absolve Business Associate of HIPAA Obligations
A receiver appointed to liquidate the assets of Filefax, Inc. has agreed to pay $100,000 to the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) in a no-fault settlement regarding potential violations of the Health Insurance Portability and Accountability Act (HIPAA).
Filefax, an entity involuntarily dissolved by the Illinois Secretary of State in August 2017, previously provided services to HIPAA covered entities, including storage, maintenance, and delivery of medical records. On February 10, 2015, OCR received an anonymous complaint alleging that an individual had transported medical records obtained from Filefax to a shredding and recycling facility to sell on February 6 and 9, 2015. OCR investigated the matter and confirmed that an individual had left medical records that contained the protected health information (PHI) of approximately 2,150 patients at the shredding and recycling facility. OCR’s investigation indicated that Filefax had either left the PHI in an unlocked truck in its parking lot or granted permission to an unauthorized person to remove the PHI from Filefax, and left the PHI unsecured outside of the Filefax facility.
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China Releases New Personal Information Privacy Standards
On January 25, 2018, China released the final version of the Personal Information Security Specification, new voluntary standards on the protection of personal information. The standards anticipate and address the “issues faced in personal information security during the rapid development of IT technology; with the protection of personal information as their core” and is meant to “regulate all phases of big data operations and related conduct, such as the collection, storage, processing, use and disclosure of personal information.” The standards will go into effect on May 1, 2018.
The standards will apply to organizations using information systems to process personal information; specific departments that involve network security, third party assessment organizations; and other organizations that deal with the oversight, management, and assessment of personal information security. Generally, they lay out the following 8 basic principles of personal information security.
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OCR Kick Starts 2018 with Severe $3.5 Million HIPAA Settlement and Corrective Action Plan
Fresenius Medical Center North America (FMCNA) agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a two-year comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA).
The no-fault resolution agreement states that FMCNA reported five separate incidents that occurred between February 23, 2012 and July 18, 2012 at five distinct FMCNA facilities (FMCNA Covered Entities). FMCNA provides centralized corporate support to the FMCNA Covered Entities, including storing patient’s medical records, creating and disseminating HIPAA policies and procedures, and investigating the circumstances surrounding each breach reported to it by the FMCNA Covered Entities.