DBR ON DATA

Security, Privacy and Information Governance

Category: Health Care



CMS Proposed Rule, Rebranding of Medicare and Medicaid Electronic Health Records Incentives Program Shifts Focus to Interoperability and Patient Access

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The Centers for Medicare and Medicaid Services (CMS) recently released its Proposed Rule that, in major part, rebrands the previously known Medicare and Medicaid Electronic Health Records (EHR) Incentives Program into the Promoting Interoperability Program. The rebrand shifts the focus of the program to ensure that providers facilitate patient access to their own health data, and  limit the burden on health care providers when it comes to monitoring clinical care using health technology.

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Continued Special Privacy Treatment for Substance Use Disorder Information

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The Senate Health, Education, Labor and Pensions Committee recently passed the Opioid Crisis Response Act of 2018 (OCRA) – a bipartisan package of more than 40 proposals designed to help families and entire communities affected by the nation-wide opioid crisis.

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US FDA Approaches to Artificial Intelligence

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Artificial Intelligence (AI) can be employed in a health care setting for a variety of tasks, from managing electronic health records at a hospital, to market research at a benefits management organization, to optimizing manufacturing operations at a pharmaceutical company. The level of regulatory scrutiny of such systems depends on their intended use and associated risks.

In the U.S., for medical devices using AI, one of the key regulatory bodies is the Food and Drug Administration (FDA), especially its Center for Devices and Radiological Health (CDRH). CDRH has long followed a risk-based approach in its regulatory policies, and has officially recognized ISO Standard 14971 “Application of Risk Management to Medical Devices.” That standard is over 10 years old now, and therefore is currently undergoing revisions – some of which are meant to address challenges posed by AI and other digital tools that are flooding the medical-devices arena.

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New York Attorney General Penalizes Health Plan for Widespread Disclosure of Social Security Numbers

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New York Attorney General Eric T. Schneiderman announced a $575,000 settlement with EmblemHealth and its subsidiary, Group Health Incorporated, (together, “EmblemHealth”) after EmblemHealth admitted a mailing error that resulted in the disclosure of 81,122 social security numbers.  EmblemHealth is one of the largest health plans in the United States.

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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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