Discerning Data

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

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

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

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

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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New Washington State Privacy Bill Incorporates Some GDPR Concepts

A new bill, titled the “Washington Privacy Act,” was introduced in the Washington State Senate on January 18, 2019. If enacted, Washington would follow California to become the second state to adopt a comprehensive privacy law.

Similar to the California Consumer Privacy Act (CCPA), the Washington bill applies to entities that conduct business in the state or produce products or services that are intentionally targeted to residents of Washington and includes similar, though not identical size triggers. For example, it would apply to businesses that 1) control or process data of 100,000 or more consumers; or 2) derive 50 percent or more of gross revenue from the sale of personal information, and process or control personal information of 25,000 or more consumers. The bill would not apply to certain data sets regulated by some federal laws, or employment records and would not apply to state or local governments.

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