ONC HTI-2 Proposed Rule: Navigating Information Blocking Compliance

By Kim Boyd, Regulatory Resource Center Lead & Senior Consultant, Point-of-Care Partners
LinkedIn: Kim Boyd
LinkedIn: Point-of-Care Partners
Read Kim’s HTI-2 Series

In our ongoing series dissecting the proposed HTI-2 rule, we’ve explored its potential to revolutionize health IT infrastructure and interoperability. Today, we’re delving into another critical portion: information blocking. If you are or may become an actor under the information blocking rules, understanding these new criteria is imperative to protect your organization from information blocking non-compliance. There will be more enforcement of the information blocking rule on the horizon, so compliance is more important than ever.

What is Information Blocking?

Information blocking refers to practices that unreasonably interfere with the access, exchange, or use of electronic health information (EHI). Under the 21st Century Cures Act, ONC passed policy providing clear guidance to mitigate the practice of information blocking and promote the seamless flow of electronic health information.

Key Provisions in the HTI-2 Proposed Rule

The HTI-2 proposed rule introduces updates and new exceptions to the existing information blocking regulations. Here’s what stakeholders need to know:

• Protecting Care Access Exception: This new exception allows actors to limit EHI sharing to reduce the risk of legal exposure for patients and providers involved in lawful reproductive health care. This provision aims to balance privacy concerns with the need for information access.
• Requestor Preferences Exception: This new framework ensures that actors won’t be penalized for information blocking if they comply with specific requests to restrict EHI availability. This exception provides clarity and flexibility, addressing concerns about patient privacy and preference.
• Expanded Privacy Exception: The revisions expand the applicability of the Privacy Exception, offering more robust protections for patient health information.
• Updated Infeasibility Exception: These updates provide greater clarity and flexibility, allowing actors to manage EHI sharing more effectively under certain conditions.

Enhanced Clarity on Definitions and Practices

The HTI-2 proposed rule also aims to enhance clarity around key definitions and practices related to information blocking:

Defined Terms:

• Health Care Provider: ONC proposes to update the text to make it clear what laboratories and pharmacists are included in this definition for the information blocking regulations. The proposed revision would not change who meets this definition.
• Interfere with or Interference: ONC proposes to add a section (§ 171.104) to the information blocking regulations that would codify certain practices (acts and omissions) that constitute interference for purposes of the information blocking definition. This proposal describes practices such as:
  • Actions taken by an actor to impose delays on other persons’ access, exchange, or use of EHI.
  • Non-standard implementation of health IT and other acts to limit interoperability of EHI.
  • Improper inducements or discriminatory contract provisions.
  • Omissions (failures to act) when action is necessary to enable or facilitate proper information sharing.

New Definitions:

• Business Day or Business Days: Codifying definitions to ensure consistent understanding across stakeholders.
• Health Information Technology or Health IT: Providing a clear definition to support compliance and implementation efforts.

Compliance Requirements for Stakeholders

To align with these new provisions, stakeholders must take several steps:

• Review and Update Policies: Health IT developers, providers, and other entities must revisit their information-sharing policies to ensure they align with the new exceptions and requirements.
• Training and Education: Organizations should invest in training their staff about the nuances of the HTI-2 rule, focusing on the implications of information blocking and the updated exceptions.
• Technological Upgrades: Ensure that health IT systems are capable of complying with the new data-sharing standards and can handle the exceptions outlined in the rule.
• Engage with Legal Counsel: Given the legal implications of information blocking, it’s crucial for stakeholders to work closely with legal experts to navigate the complexities of these regulations.

Strategic Advantages of Compliance

By proactively addressing these requirements, stakeholders can turn compliance into a strategic advantage:

• Enhanced Trust and Reputation: Demonstrating a commitment to patient privacy and seamless information exchange can enhance trust with patients and partners.
• Operational Efficiency: Streamlined information-sharing processes can lead to more efficient operations and better patient outcomes.
• Competitive Edge: Staying ahead of regulatory requirements positions organizations as leaders in health IT innovation, potentially attracting more business and partnerships.

For more details, refer to the ONC HTI-2 Proposed Rule and the HHS Press Release.

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This article was originally published on the POCP blog and is republished here with permission.