Health Care Archives - Page 2 of 8

FDA Expands Big Data Use with Sentinel System

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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England’s National Health Service Long Term Plan Envisions NHS-wide Adoption of Digital Tools

The National Health Service (NHS) oversees health services in England, and under that government’s direction sets strategic objectives for the health care system as a whole. The other constituent countries of the United Kingdom (UK) – Scotland, Wales and Northern Ireland – similarly have their own public-health agency each. Any UK resident may obtain health services through any of these independent organizations – either for free or at a much lower price than through a private provider.

Last year, NHS celebrated its 70th anniversary. The milestone prompted a national conversation about the role and future of that organization. In part in response to that debate, the agency prepared and recently released “The NHS Long Term Plan,” outlining its vision for servicing public health in the next decade. A previous strategic document, “NHS Five Year Forward View” (2014), created a foundation for the current planning by setting in motion some of the initiatives that are now being projected to be spread to the entire system.

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HHS Task Group Releases Cybersecurity Guidelines for the Health Care Industry

Health care is one of the most complex and socially impactful areas of digitalization. Ensuring cybersecurity of health care operations, therefore, is of paramount importance – because potential vulnerabilities may lead not only to financial or technical exposures, but to lapses in life-or-death situations for patients.

To assist practitioners with education and guidelines, and in pursuance of Cybersecurity Act of 2015 (Public Law 114-113), Section 405(d), the Department of Health and Human Services created a “405(d) Task Group” in May 2017, involving, more than 150 health care and cybersecurity experts. The result of their collaborative work became a voluntary guideline entitled “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” which was released at the end of 2018.

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New Handbook Provides Guidance to Healthcare Delivery Organizations on Preparation and Response to Medical Device Cybersecurity Incidents

Recently, the MITRE Corporation, in collaboration with the U.S. Food and Drug Administration (FDA), announced the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. The Playbook was designed to provide “tools, references, and resources” for Healthcare Delivery Organizations (HDOs) to better prepare for and respond to medical device cybersecurity incidents.

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Employee’s Illegal Access to Patient Records Results in Data Breach of 15,000 Patients: Hospital System to Pay for Violations

UMass Memorial Medical Center, Inc., and UMass Memorial Medical Group, Inc. (collectively, UMass) has agreed to pay $230,000 to settle claims alleging that that they violated the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), and various other state patient privacy laws.

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Three Separate OCR Settlements Resulting from Hospital Failures to Obtain Patient Authorization for Use of Protected Health Information Before Filming Television Docuseries

The Department of Health and Human Services, Office for Civil Rights (OCR) announced three separate settlements with Boston Medical Center (BMC), Brigham and Women’s Hospital (BWH), and Massachusetts General Hospital (MGH), respectively, over potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule totaling $999,000. According to the settlements, the potential violations were the result of the alleged disclosure of patient protected health information (PHI) to ABC News employees during the production and filming of the docuseries called “Save My Life: Boston Trauma,” at each hospital.

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DISCERNING DATA

A Faegre Drinker Blog Covering the Latest in Privacy, Cybersecurity and Data Strategy

Category: Health Care