The Role of Information Blocking Rules in Enhancing Interoperability in Healthcare: Challenges and Best Practices for Compliance

Information blocking means any action by a healthcare group—like doctors, health IT makers, or health networks—that stops or slows down access, sharing, or use of electronic health information (EHI). This idea became important with the 21st Century Cures Act of 2016, with rules starting in April 2021 and added to in October 2022. The goal is to make health information move freely and improve patient care quality and teamwork.

The main groups affected by these rules include healthcare providers (like doctors and hospitals), certified health IT makers, and organizations like health information exchanges (HIEs). The Office of the National Coordinator for Health Information Technology (ONC) requires these groups to give timely and safe access to electronic health data, unless certain exceptions apply.

Some exceptions exist to protect patient safety, privacy, security, and other valid reasons. These include:

• Stopping harm to patients or others.
• Protecting privacy and sensitive information.
• When technology makes sharing impossible.
• Managing IT performance to avoid system overload.
• Applying fees and licenses legally.

Healthcare providers need to use these exceptions carefully. Using them too much or wrongly can count as illegal information blocking and bring penalties.

Penalties can be serious. Providers might face warnings, but health IT creators and groups like HIEs can be fined up to $1 million for each violation. Also, health IT product certifications can be taken away for not following the rules.

The Importance of Interoperability in Healthcare

Interoperability means different healthcare systems can share, understand, and use data well. It helps coordinate care by letting doctors access patient info quickly and accurately. This also lowers mistakes and helps patients manage their health.

The CMS Interoperability and Patient Access Final Rule (CMS-9115-F), released in 2020, pushed these goals further. It requires Medicare Advantage, Medicaid, CHIP, and Qualified Health Plan issuers to use standard APIs based on the HL7 FHIR (Fast Healthcare Interoperability Resources) format. This lets patients and doctors securely access claims, clinical info, and other health data through apps or electronic health records (EHRs).

Interoperability also improves admin tasks like automating prior authorizations, which saves paperwork and speeds up care. The bigger aim is a health system where information is ready when needed to help better care decisions and patient results.

The Trusted Exchange Framework and Common Agreement (TEFCA), required by the 21st Century Cures Act and run by HHS, sets a federal plan for safe sharing of electronic health info across the country. TEFCA brings Qualified Health Information Networks (QHINs) together using shared rules and standards to improve interoperability between different networks.

Challenges Medical Practices and Healthcare IT Managers Face

Even though these changes aim to improve healthcare communication, following the rules is hard. Medical practice leaders, owners, and IT managers face many challenges:

• Technical Capabilities and Infrastructure
  Many healthcare providers use old EHR or IT systems that don’t support new API standards or detailed data sharing. Some systems can’t separate sensitive info like adolescent health or genetic data properly, which risks accidental information blocking. HHS accepts “technical infeasibility” as a valid exception, but providers must clearly document these limits.
• Balancing Privacy and Access
  Providers must follow different laws about patient privacy, especially for sensitive info like reproductive health, mental health, or substance use records. The Protecting Care Access Exception lets providers withhold some data legally, but policies and documents must manage this carefully to avoid breaking information blocking rules.
• Timeliness and Documentation
  Rules say electronic health info, like notes and lab results, must be shared quickly after getting it. Waiting for doctor review can cause delays that count as blocking unless there is a good reason. Organizations must keep up-to-date records that explain any exceptions used. The AMA suggests putting exception forms into doctors’ daily routines to keep compliance steady.
• Workforce Training and Awareness
  Regulations change quickly, so staff need ongoing training. They must know the rules about accessing info, how to use exceptions well, and how to keep records right. Security training is important too, since healthcare data often faces hacking risks.
• Vendor Management and Collaboration
  Health IT makers must build products that follow information blocking rules. Medical practices should work with EHR vendors to understand system limits, needed upgrades, and tools for compliance. Vendors can lose federal certification if they break rules, so they play a key role in staying compliant.
• Potential Penalties and Reputational Risk
  Not following the rules can cause big fines, investigations by the Office of the Inspector General (OIG), and harm an organization’s reputation. In 2020, healthcare made up 28.5% of all data breaches, affecting over 26 million people. Safe and open sharing of health info is very important.

Best Practices for Information Blocking Compliance and Interoperability

To meet the rules and support interoperability, healthcare groups should follow these good practices:

• Establish or Update Compliance Programs
  Every group should have a compliance program that includes healthcare law, IT, and privacy knowledge. This plan should set clear policies for access, sharing, and use of EHI, and show how to use information blocking exceptions the right way.
• Document Exception Use Thoroughly
  Every time an exception is used, detailed and current documentation is needed. Using real examples helps groups get ready for audits or investigations. Putting exception forms into EHR workflows can make following the rules easier.
• Engage EHR Vendors Early and Regularly
  Work with EHR vendors to make sure technology fits FHIR standards and can separate data when needed. Providers should know the vendor’s compliance plans and join their training and updates.
• Provide Regular Staff Training
  Keep staff up to date on current rules, the group’s policies, and security risks. Keep records of who attends to show compliance efforts.
• Maintain Transparent Patient Communication
  Patients have rights under laws like HIPAA and CCPA to get their health info on time and fully. Organizations should have ways to handle requests quickly while respecting privacy or legal exceptions.
• Monitor Business Associate Compliance
  Providers are responsible for their partners following HIPAA and information blocking rules. Doing regular reviews and managing contracts well can lower risk.
• Balance Privacy with Sharing Under Minimum Necessary Standard
  Sharing only the least info needed for a specific use helps protect privacy. But providers must make sure this does not block important info needed for care or following rules.

Enhancing Compliance with AI and Workflow Automation

Using artificial intelligence (AI) and workflow automation can help improve following information blocking rules and sharing health info. AI can handle routine tasks, cut mistakes, and manage data better.

For example:

• Automated Data Classification and Segmentation
  AI can find protected health information (PHI) in large data sets and sort data by sensitivity. This helps apply privacy rules right, like restricting access to sensitive adolescent or reproductive health info.
• Streamlined Documentation
  Automated workflows in health IT systems can remind providers to finish required exception documents. Putting these reminders in daily tasks lowers risks and paperwork.
• Real-Time Monitoring and Alerts
  AI can watch data sharing to spot possible rule violations or delays that look like blocking. Alerts can warn compliance staff before problems grow.
• Optimizing Patient Requests Management
  Automated systems can track health info requests, make sure they are fulfilled on time, and handle complex exceptions. This cuts manual work and helps patients.
• Risk Analysis and Security Management
  AI tools can analyze risks in health info systems early. Finding problems fast helps stop data breaches, which are a big risk for rule violations and blocking claims.

Adding AI to compliance tasks fits well with healthcare goals: lowering staff workload, improving accuracy and consistency, and offering solutions that grow to meet more rules.

Specific Considerations for Healthcare Administrators and IT Managers in the U.S.

Healthcare administrators and IT managers in U.S. medical practices and hospitals have important roles in making these changes work:

• Administrators must make sure policies match federal rules, watch staff training, and manage vendor contracts so following rules is part of daily work.
• IT managers handle technology updates, safe data sharing with APIs following CMS and ONC standards, and use AI for automation and monitoring where possible.

Because fines and patient trust are on the line, a teamwork approach between administration and IT is needed. The many federal and state rules and changing compliance standards mean legal, clinical, and IT teams must keep working together.

By focusing on following Information Blocking Rules and using technology like AI, healthcare providers can improve how systems work together. This helps care coordination, quick response to patient data requests, and meeting federal rules. Medical practice leaders, business owners, and IT managers should build strong, clear, and efficient ways to handle rules while managing day-to-day work.