Month: February 2019 (page 1 of 2)

$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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Another Big Blockchain Initiative Announced in Health Care Insurance Industry

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Several large health insurance companies, including Aetna, Anthem, and Healthcare Service Corporation, have announced a collaboration with PNC Bank and IBM to utilize blockchain technology to “improve transparency and interoperability in the health care industry” and “address a range of industry challenges, including promoting efficient claims and payment processing, to enable secure and frictionless healthcare information exchanges, and to maintain current and accurate provider directories.”

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FDA Expands Big Data Use with Sentinel System

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The U.S. Food and Drug Administration (FDA) is increasing its capability to harness the power of big data – or more specifically of the “real world evidence” (RWE) – to assess the safety of medical products that are approved for the U.S. market. To that end, FDA is expanding its Sentinel System so that by the end of 2023 it would represent “a transformative, multi-purpose national data and scientific resource center for evidence generation that a wide array of stakeholders use to inform all aspects of healthcare decision making,” according to the recently released Sentinel System Five-Year Strategy.

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