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May 17, 2022 04:00 AM

Navigating data guidelines and regulations

Mari Devereaux
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    In the absence of federal regulations specifically governing the collection and use of patient-generated health data, providers tend to rely on more general rules and guidelines about handling medical information.

    The Health Insurance Portability and Accountability Act, which became law more than a quarter-century ago, restricts providers’ authority to share patient data with other entities and guarantees patients access to their own information upon request.

    The 21st Century Cures Act of 2016 requires health systems to allow patients on-demand, fully online access to their data, including the clinical notes in their electronic health records.

    But state laws with stricter rules about how healthcare data are managed, stored and transmitted complicate matters, said Aaron Miri, senior vice president and chief digital and information officer of Jacksonville, Florida-based Baptist Health. Miri is co-chair of the Health and Human Services Department’s Health Information Technology Advisory Committee.

    Moreover, many companies that market consumer health informatics tools, including wearables, aren’t subject to the HIPAA regulations that traditional health information technology vendors must follow, Miri said.

    Mismatched rules and the lack of comprehensive privacy and security regulations are obstacles to health systems endeavoring to incorporate patient-generated health data into clinical operations, he said.

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    Some health systems and software vendors are using the Fast Healthcare Interoperability Resources standard to inform how patient-generated health data sources such as scales, monitors and fitness trackers connect to clinical workflows and EHRs, he said.

    Health Level Seven International, a standards development organization, created FHIR to harmonize data formats and application programming interfaces for exchanging information between systems.

    In 2015, HHS’ Office of the National Coordinator for Health Information Technology initiated a project to identify gaps, best practices and opportunities for progress in the collection and use of patient-generated health data in care delivery and research. The agency is also developing a policy framework for data collected by patients. New rules on this front could be transformative, Miri said.

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    • News
      • Current News
      • Providers
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      • Government
      • Finance
      • Technology
      • Safety & Quality
      • Digital Health
      • Transformation
        • Patients
        • Operations
        • Care Delivery
        • Payment
      • ESG
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition (Web Version)
    • Blogs
      • AI
      • Deals
      • Layoff Tracker
      • HIMSS 2023
    • Opinion
      • Breaking Bias
      • Commentaries
      • Letters
      • From the Editor
    • Events & Awards
      • Awards
        • Nominate/Eligibility
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • Best Places to Work in Healthcare
        • Excellence in Governance
        • Health Care Hall of Fame
        • Healthcare Marketing Impact Awards
        • Top 25 Emerging Leaders
        • Top Innovators
        • Diversity in Healthcare
          • - Luminaries
          • - Top 25 Diversity Leaders
          • - Leaders to Watch
        • Women in Healthcare
          • - Luminaries
          • - Top 25 Women Leaders
          • - Women to Watch
      • Conferences
        • Digital Health Transformation Summit
        • ESG: The Implementation Imperative Summit
        • Leadership Symposium
        • Social Determinants of Health Symposium
        • Women Leaders in Healthcare Conference
      • Galas
        • Best Places to Work Awards Gala
        • Health Care Hall of Fame Gala
        • Top 25 Diversity Leaders Gala
        • Top 25 Women Leaders Gala
      • Virtual Briefings
        • - Hospital of the Future
        • - Value Based Care
        • - Hospital at Home
        • - Workplace of the Future
        • - AI and Digital Health
        • - Future of Staffing
        • - Hospital of the Future (Fall)
      • Webinars
    • Multimedia
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Sponsored Video Series - One on One
      • Sponsored Video Series - Checking In with Dan Peres
    • Data & Insights
      • Data & Insights Home
      • Hospital Financials
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