Understanding information blocking

The Cures Act defines information blocking as “a practice that interferes with, prevents, or materially discourages access, exchange, or use of electronic health information,” except as required by law or covered by an exception defined by the Secretary of HHS. The intent is to ensure that EHI is available when and where it is needed, thereby promoting better healthcare outcomes.

Understanding information blocking

Information blocking refers to practices that prevent or materially discourage the access, exchange, or use of electronic health information (EHI). This concept is particularly relevant in the healthcare sector, where interoperability and the seamless sharing of health data among different stakeholders (such as patients, healthcare providers, and insurers) are crucial for improving care quality and efficiency.

The 21st Century Cures Act, which took effect in December 2016, tackles the issue of information blocking in U.S. healthcare regulations.

Types of information blocking

• Technical barriers: These include the use of proprietary interfaces or non-standardized formats that hinder data interoperability. For instance, a health IT system might use a non-standard data format that cannot be easily integrated with other systems.
• Contractual barriers: These involve the use of contracts or policies that restrict the sharing of EHI. For example, a contract might prohibit a healthcare provider from sharing patient data with another provider.
• Administrative barriers: These are unnecessary procedures or delays that impede timely access to EHI. An example is requiring multiple layers of approval before data can be shared.
• Financial barriers: These include charging excessive fees for accessing or exchanging EHI. For instance, a health IT vendor might impose high fees for data export services.

See also: HIPAA Compliant Email: The Definitive Guide

Regulatory framework

21st Century Cures Act

Enacted in December 2016, the 21st Century Cures Act is a significant piece of legislation aimed at accelerating medical product development and bringing innovations and advances to patients who need them faster and more efficiently. A key part of the Act is the prohibition against information blocking.

See also: The relationship between the Cures Rule and HIPAA compliance

Office of the National Coordinator for Health Information Technology (ONC)

The ONC is responsible for implementing the information blocking provisions of the Cures Act. They define what constitutes information blocking and outline exceptions.

Exceptions to information blocking

The ONC has established eight categories of exceptions where practices that might otherwise be considered information blocking are permissible. These exceptions are designed to ensure that legitimate reasons for restricting access to EHI are recognized. The exceptions are:

• Preventing harm exception: Practices intended to prevent harm to a patient or another person.
• Privacy exception: Practices that protect an individual's privacy.
• Security exception: Practices that protect the security of EHI.
• Infeasibility exception: When it is not feasible to provide access, exchange, or use of EHI.
• Health IT performance exception: Practices that temporarily make EHI unavailable due to the need for maintenance or improvements.
• Content and manner exception: Limits on the content or manner of EHI access, exchange, or use.
• Fees exception: Fees that are charged for accessing, exchanging, or using EHI are permissible if they meet certain criteria.
• Licensing exception: Licensing of interoperability elements on reasonable and non-discriminatory terms.
  
  

Enforcement

The ONC, in coordination with the HHS Office of Inspector General (OIG), enforces the information blocking rules. Health IT developers, health information networks, and health information exchanges found to be engaging in information blocking practices may face civil monetary penalties. For healthcare providers, the consequences can include disincentives or corrective actions but are not necessarily financial penalties.

Implications of information blocking

• Patients: Information blocking can lead to fragmented care, as different providers may not have access to a patient's complete medical history. This can result in redundant tests, increased costs, and potentially adverse health outcomes.
• Healthcare providers: Providers may face challenges in coordinating care and making informed clinical decisions without timely access to comprehensive patient data. Information blocking can also hinder participation in value-based care models that rely on data sharing.
• Health IT developers: Developers need to ensure their systems are interoperable and compliant with regulatory requirements to avoid penalties and maintain market credibility.
• Healthcare system: Reducing information blocking can lead to improved data sharing, enhanced patient care, reduced costs, and better public health outcomes by enabling more effective disease surveillance and research.

FAQs

Why is information blocking a concern?

Information blocking can impede the efficient and effective exchange of health information, leading to fragmented care, redundant testing, increased costs, and potential harm to patients due to incomplete medical records

Who is affected by the information blocking rules?

Information blocking rules apply to:

• Health care providers.
• Health IT developers of certified health IT.
• Health information networks (HINs) and health information exchanges (HIEs).

How can healthcare providers ensure they are not engaging in information blocking?

Providers should:

• Stay informed about information blocking rules and regulations.
• Ensure that their health IT systems are interoperable and capable of exchanging EHI.
• Avoid unnecessary delays or restrictions in sharing EHI.
• Implement policies that promote transparency and data sharing.