Information Blocking Rules: Keane Signals Coming Changes

Federal Action Intensifies Against Health Data Blocking

The Department of Health and Human Services (HHS) has initiated its first enforcement actions against health IT developers suspected of impeding patient access to their electronic health information. This marks a significant escalation in the government’s efforts to enforce the 21st Century Cures Act, which aims to promote interoperability and patient control over health data. The HHS is collaborating with the Department of Justice, the Federal Trade Commission, and the HHS Office of Inspector General to bolster this enforcement push.

Thomas Keane, MD, MBA, Assistant Secretary for Technology Policy and National Coordinator for Health IT, emphasized the seriousness of these actions, signaling a zero-tolerance policy for practices that obstruct the seamless flow of health information. The move comes after a period of education and awareness campaigns, suggesting that developers have had ample opportunity to comply with information-sharing regulations. What impact will these initial enforcement notices have on the broader health IT landscape?

Understanding Information Blocking and the Cures Act

Information blocking refers to practices by health IT developers, health information exchanges, and providers that unreasonably limit the access, exchange, or use of electronic health information. The 21st Century Cures Act, signed into law in 2016, mandated the development of rules to address this issue, with the goal of empowering patients and fostering innovation in healthcare. The Act recognizes that patients should have easy access to their health data, and that this access is crucial for informed decision-making and improved health outcomes.

The HHS Office of the National Coordinator for Health IT (ONC) has defined specific exceptions to the information blocking rule, recognizing legitimate reasons for restricting access, such as protecting patient privacy or ensuring data security. However, the current enforcement actions suggest that the HHS believes some developers are exceeding these exceptions and engaging in practices that are deliberately hindering data access.

The penalties for information blocking can be substantial, ranging from financial fines to legal action. The involvement of the Department of Justice and the Federal Trade Commission underscores the government’s commitment to holding accountable those who violate these regulations.

Beyond legal repercussions, information blocking can erode patient trust and hinder the development of innovative healthcare solutions. When patients are unable to access their data, they are less able to participate actively in their care, and researchers are limited in their ability to analyze data to improve treatments and outcomes.

Pro Tip: Healthcare organizations should proactively review their IT systems and data-sharing practices to ensure compliance with the Cures Act and avoid potential penalties.

The HHS’s actions are not limited to developers. Providers who knowingly engage in information blocking can also face penalties. This holistic approach aims to create a healthcare ecosystem where data flows freely and patients are at the center of their care.

For more information on the 21st Century Cures Act and information blocking, visit the ONC’s Cures Act website. To understand the role of interoperability in modern healthcare, explore resources from HIMSS.

Frequently Asked Questions About Health Data Blocking

Here are some common questions about health data blocking and the recent enforcement actions:

  • What exactly constitutes “information blocking”?

    Information blocking refers to practices that unreasonably limit the access, exchange, or use of electronic health information, hindering patient control and interoperability.

  • How does the 21st Century Cures Act address information blocking?

    The Cures Act mandated the development of rules to prevent information blocking, empowering patients and fostering innovation in healthcare through improved data access.

  • What are the potential penalties for health IT developers found to be blocking information?

    Penalties can include financial fines and legal action from the Department of Justice and the Federal Trade Commission.

  • Are there any legitimate reasons for restricting access to health data?

    Yes, exceptions exist to protect patient privacy, ensure data security, and address other valid concerns, as defined by the HHS ONC.

  • How can patients ensure they have access to their health information?

    Patients should request access to their electronic health records from their healthcare providers and utilize patient portals when available.

  • What role does interoperability play in preventing information blocking?

    Interoperability – the ability of different health IT systems to exchange and use data – is crucial for breaking down data silos and enabling seamless information sharing.

The HHS’s recent actions represent a pivotal moment in the ongoing effort to modernize healthcare and empower patients. As enforcement intensifies, health IT developers and providers will be under increasing pressure to prioritize data access and interoperability. Will this lead to a fundamental shift in how health information is managed and shared across the industry?

Share this article with your network to raise awareness about the importance of health data access and the ongoing fight against information blocking. Join the conversation in the comments below – what are your thoughts on these enforcement actions?

Disclaimer: This article provides general information and should not be considered legal or medical advice. Consult with a qualified professional for specific guidance.

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