Month: February 2019 (page 1 of 2)

U.S. Department of Education Issues Updated Student Privacy Guidance Following Federal Commission on School Safety Report

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On February 5, 2019, the U.S. Department of Education (ED) released new and important regulatory guidance entitled “School Resource Officers, School Law Enforcement Units, and the Family Educational Rights and Privacy Act.” This guidance document was prepared and issued in response to the December 2018 final report of the Federal Commission on School Safety (the Commission), which was established following the February 2018 shooting at Marjory Stoneman Douglas High School in Parkland, Florida. Among the findings of that final report was the following, which concerns threat assessment efforts in the nation’s schools:

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GAO Report Recommends Congress Consider Comprehensive Privacy Regulation

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The GAO recently concluded a comprehensive analysis of the U.S. federal regulatory landscape with respect to internet privacy, specifically focusing on FTC and FCC enforcement actions and authorities. GAO interviewed representatives from industry, consumer advocacy groups, academia, FTC and FCC staff, former FTC and FCC commissioners, and officials from other agencies. (See page 40 of the GAO report for a complete list of those interviewed.) GAO recommends that Congress consider developing comprehensive legislation on internet privacy that would enhance existing consumer protections and provide flexibility to address a rapidly evolving privacy environment.

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$3 Million Settlement for Two Separate HIPAA Breaches Affecting Over 62,500 Individuals

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Cottage Health and the Office for Civil Rights at the U.S. Department of Health and Human Services (HHS-OCR) recently entered into a $3 million no-fault settlement and three year corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA). This was HHS-OCR’s last HIPAA related settlement of 2018 – a record year in HIPAA enforcement activity, as detailed in this DBR on Data blog post.

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New Executive Order on Maintaining American Leadership in Artificial Intelligence

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On February 11, 2019, President Trump signed an Executive Order on “Maintaining American Leadership in Artificial Intelligence.”  The Executive Order (EO) recognizes that the United States is the world leader in AI research and development (R&D) and deployment,” and that “[c]ontinued American leadership in AI is of paramount importance. . . .”

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2018 An All-Time Record Year for HIPAA Enforcement Actions by HHS-OCR

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The Office for Civil Rights at the U.S. Department of Health and Human Services (HHS-OCR) had a record-breaking year in 2018 with Health Insurance Portability and Accountability Act (HIPAA) enforcement activity.  HHS-OCR entered into 10 settlements and received summary judgment in a case before an Administrative Law Judge, totaling nearly $28.7 million in enforcement actions. According to the HHS-OCR Director, Roger Severino, this record year underscores the need for covered entities to be proactive about their HIPAA data security.

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FDA Releases Updated Working Model for Software Precertification Program

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The U.S. Food and Drug Administration (FDA) recently released “A Working Model v.1.0” for its Software Precertification Program, which is aimed at organizations that design, test and monitor software products used for medical purposes (“Software as Medical Device” or “SaMD” products).  The goal of the Software Precertification Program is to encourage innovation in digital health technologies by streamlining regulatory approaches while ensuring patient safety and device effectiveness.

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