In recent years, the healthcare industry has been making significant strides toward achieving interoperability, a crucial element in delivering high-quality patient care. Central to this effort is eliminating information blocking, a practice that hinders the exchange of electronic health information (EHI). With the enforcement of information-blocking regulations in full swing, healthcare entities face substantial penalties for non-compliance. This article will explore how enforcing information-blocking rules drives interoperability and transforms the healthcare landscape.
ONC’s 2020 Cures Act Final Rule paved the way for health data interoperability by implementing key provisions of the 21st Century Cures Act. One of the critical components of this rule is the prohibition of information blocking, which impedes or obstructs the access, exchange, or use of Electronic Health Information (EHI). Despite its enactment in April 2021, the lack of practical enforcement mechanisms allowed information blocking to persist within the healthcare industry.
Information Blocking Enforcement Policies
On June 27, 2023, the HHS Office of Inspector General (OIG) posted the final rule implementing information blocking penalties – a game-changer in the battle against information blocking. Effective September 1, 2023, this rule grants OIG the authority to enforce penalties of up to $1 million per instance of information blocking.
Identifying Information Blocking
Healthcare entities must closely scrutinize their data access policies to comply with the information-blocking regulations. One of the areas of concern highlighted by Sean Sullivan, a healthcare regulatory and compliance attorney, involves contractual terms that limit competition. For instance, Electronic Health Record (EHR) vendors prohibiting hospitals from using specific vendors to access health information are considered information blocking. Imposing unnecessary licensing terms, fees, training requirements, or waiting periods to hinder access to health records also falls under this category.
The Changing Landscape
The enforcement of information-blocking rules marks a significant shift in the healthcare industry. It forces technology vendors and health IT companies to make health information accessible to other vendors, promoting competition and innovation. Although these companies may have reservations about opening their data to competitors, they are now obliged to do so under the regulations.
OIG’s Prioritization: with the expectation of a surge in information-blocking complaints, OIG will prioritize cases for investigation based on specific criteria. These include instances that caused patient harm, significantly impacted patient care delivery, had long-lasting effects, caused financial loss to healthcare programs, were performed with actual knowledge, or resulted from interference with access to electronic health information. OIG may also use data from the ONC’s information-blocking complaint portal, which received 821 submissions by July 31, 2023, to guide its enforcement efforts.
While healthcare providers are not currently subject to civil monetary penalties under OIG’s final rule, a proposed rule from ONC may establish disincentives for information blocking by providers. The disincentives could include fines through the Centers for Medicare & Medicaid Services (CMS) or potential audits leading to termination from Medicare programs. Healthcare providers must, therefore, remain vigilant and align their data-sharing practices with the evolving regulatory landscape.
Strategies to Avoid Information Blocking
Healthcare executives across the industry must implement strategies fostering interoperability, transparency, and ethical data sharing to ensure their organization is not involved in information blocking. Here are several steps and processes to achieve this goal:
- Commitment to Interoperability: Establish a clear and unwavering commitment to interoperability as a core principle of your organization’s mission and vision. Make it known that information blocking is unacceptable and that the organization prioritizes seamless healthcare data exchange. In support of this, establish an ethical governance framework that upholds the principles of data sharing, patient privacy, and interoperability. Ensure that ethical considerations are woven into your decision-making processes.
- Adherence to Regulatory Compliance: Sullivan highlighted the need to harmonize information-blocking rules with federal and state laws concerning healthcare data privacy and security, like the Health Insurance Portability and Accountability Act (HIPAA). The information-blocking provisions must align with existing regulations to ensure a consistent approach. Ensure strict compliance with these regulations and be proactive in adopting industry standards like HL7 and FHIR.
- Educate Your Team: Provide comprehensive training to your team, including developers, product managers, and customer support staff, on the importance of interoperability and the consequences of information blocking. Foster a culture of ethical data sharing within the company.
- Transparent Pricing and Licensing: Avoid pricing and licensing models that hinder data sharing. Ensure your pricing structures do not discourage customers from sharing data with other healthcare entities. Transparency in pricing is vital.
- Open APIs: Develop open Application Programming Interfaces (APIs) that allow customers to connect your systems easily with other healthcare applications and EHRs. Promote open APIs as a standard feature of your products.
- Data Portability: Make it easy for customers to extract their data from your systems in a standardized format. Ensure that customers have control over their data and can easily migrate it to other systems.
- Patient Access: Support patient access to their health records through your systems. Enable patients to access, download, and share their data with other healthcare providers and apps per the 21st Century Cures Act regulations.
- Interoperability Testing: Regularly conduct interoperability testing with other healthcare technology vendors and systems. Ensure your products seamlessly exchange data with a wide range of systems and promptly address any issues.
- Transparency and Accountability: Maintain transparency in your operations. Publish information about your data-sharing practices, security measures, and privacy policies. Be accountable for any data breaches or privacy violations, promptly addressing and rectifying such issues.
- Regular Audits and Assessments: Conduct internal audits and assessments of your data-sharing practices to identify any potential issues related to information blocking. Address these issues promptly to ensure compliance.
The enforcement of information-blocking regulations is a pivotal moment in the journey toward healthcare interoperability. It drives the dismantling of data silos and encourages competition, innovation, and improved patient care coordination. Healthcare entities must adapt their data access policies to comply with these regulations, fostering a more transparent and interconnected healthcare ecosystem. As the healthcare industry evolves, it’s essential to prioritize interoperability and eliminate information blocking to benefit patients and providers.
Smartlink Health specializes in EHR and other health IT system integration. Our Integration Platform-as-a-Service (iPaaS) supports traditional API and database integration approaches when appropriate, but our uniqueness lies in our ability to overcome EHR vendor limitations by extracting and inserting data via the user interface. For more information, visit www.smartlinkhealth.com.
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