DOJ Announces Federal Indictment in Massive Cyberfraud Enterprise

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The Department of Justice announced the unsealing of a federal indictment charging 36 individuals for their alleged roles in the Infraud Organization, an Internet-based cybercriminal enterprise that is alleged to have engaged in a large-scale cyberfraud.   The indictment alleges that the enterprise caused more than $530 million in actual losses to consumer, businesses, and financial institutions.

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European Commission Issues GDPR Guidance

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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.

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NIST Releases Draft Report on IoT Cybersecurity Standards; Comments Due April 18

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On February 14, 2018, the National Institute of Standards and Technology (NIST) released a draft of its NIST Interagency Report 8200 (NISTIR 8200), which is intended to inform policymakers and standards participants in developing and implementing cybersecurity standards in and for IoT devices and systems.  At a high level, the draft report is intended to:

  • provide a functional description for IoT (Section 4);
  • describe several IoT applications that are representative examples of IoT (Section 5);
  • summarize the cybersecurity core areas and provides examples of relevant standards (Section 6);
  • describe IoT cybersecurity objectives, risks, and threats (Section 7);
  • provide an analysis of the standards landscape for IoT cybersecurity (Sections 8 and 9); and
  • map IoT relevant cybersecurity standards to cybersecurity core areas (Appendix D).

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Information Injury Workshop Covers Non-Financial Harms Faced By Consumers

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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

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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.

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Involuntary Dissolution Does Not Absolve Business Associate of HIPAA Obligations

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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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