The implementation of electronic health records (EHR) systems in healthcare settings is not just a technological upgrade; it is a complex process deeply intertwined with regulatory compliance. EHR compliance requirements ensure that EHR systems are designed, implemented, and maintained to protect patient data and enhance the overall quality of healthcare delivery.
Failure to comply with these EHR functional requirements can result in significant penalties, data breaches, and compromised patient safety. The article will explore the key regulatory EHR requirements that govern its implementation and offer a comprehensive guide to ensure that healthcare providers are fully equipped to meet these challenges.
The Health Insurance Portability and Accountability Act (HIPAA), adopted in 1996 and later expanded by the HITECH Act in 2009, applies to covered entities and business associates involved in handling protected health information (PHI). It is a cornerstone of EHR compliance that sets the framework for how patient information should be handled, stored, and transmitted within EHR systems.
The importance of HIPAA compliance is underscored by incidents such as the 2015 cyberattack on Medical Informatics, an EMR company. This breach compromised the PHI (Patient Health Information) of 3.5 million patients. Such breaches are not uncommon; in 2020 alone, 393 incidents involving PHI were reported to the department of health and human services (HHS), including email hacking and unauthorized access to downloading PHI onto unauthorized devices.
HIPAA's regulatory framework consists of two primary components: the ‘Privacy Rule’ and the ‘Security Rule’. The privacy rule establishes EMR standards for accessing PHI, which grants patients rights over their health information and sets boundaries on how it can be used and shared. The security rule outlines the necessary administrative, technical, and physical safeguards to protect patients' health information, particularly within EHR systems.
To ensure HIPAA compliance for electronic health records, healthcare organizations must implement administrative, physical, and technical safeguards. Administrative safeguards involve policies for managing security measures. Physical safeguards protect systems and facilities from hazards and unauthorized access. Technical safeguards secure and control access to electronic protected health information (ePHI).
The Health Information Technology for Economic and Clinical Health (HITECH) Act was enacted in 2009 to accelerate the adoption of EHRs across the U.S. healthcare system. The Act aims to improve healthcare quality, safety, and efficiency through the promotion of health IT.
The ‘Meaningful Use’ program, funded by a portion of the $25 billion budget allocated to the HITECH Act, was designed to incentivize healthcare providers to adopt certified EHR systems. The program's goals included enhancing care coordination, increasing efficiency, reducing costs, ensuring data privacy and security, and promoting patient engagement.
Initially, the program offered substantial financial incentives to encourage compliance. However, starting in 2015, providers who did not meet the meaningful use standards faced penalties, with Medicare reimbursement reductions beginning at 1% and increasing to 3% by 2017 for non-compliance.
Compliance with regulations set forth by the Centers for Medicare and Medicaid Services (CMS) are designed to ensure that EHR systems are implemented in a way that maintains program integrity and meets federal standards.
To aid in compliance, the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) offers guidance on establishing effective compliance programs, which outlines seven core components:
The state and federal regulations ensure that EHR systems are functional, secure, and compliant across all levels of healthcare delivery. At the federal level, the HIPAA and the HITECH Act form the foundation of EMR compliance requirements. State regulations add another layer of complexity, as each state has its own set of requirements, including additional privacy protections, reporting obligations, and specific criteria for data storage and access.
To navigate these regulations effectively, healthcare providers would need to develop a comprehensive compliance program with clear policies and procedures that address both federal and state requirements.
The 21st century ‘Cures Act’ introduced critical provisions aimed at advancing healthcare technology, including regulations against information blocking. These functional requirements for the EHR system prohibit practices to unreasonably access, exchange, or use of electronic health information (EHI).
Additionally, the Office of the National Coordinator for Health Information Technology (ONC Health IT) established the ‘Health IT Certification Program’, which ensures that EHR systems meet the technical standards necessary for secure health information exchange.
Interoperability standards are important for data exchange, with FHIR (Fast Healthcare Interoperability Resources) being the gold standard in this domain. Developed by HL7 International, FHIR ensures that custom EHR systems can effectively communicate with other systems and applications.
The complexities of data protection, interoperability, and evolving regulatory requirements can present significant challenges while implementing EHR systems. However, understanding these obstacles and applying strategic solutions can help mitigate risks.
The evolution of EMRs is marked by the integration of advanced technologies, including AI-driven decision support systems, predictive analytics, and telemedicine integration. Additionally, the push for interoperability, supported by technologies like blockchain and FHIR, ensures secure data exchange across different healthcare platforms.
Another significant trend is the integration of personalized medicine and genomics within EMR Software, enabling tailored treatment plans based on genetic data. These evolving trends and hybrid technologies are setting the stage for a more connected and patient-centric healthcare system.
When partnering with EHR vendors, it's important to engage with experienced developers who are well-versed in the complex EHR regulations surrounding healthcare data. This knowledge enables them to build systems that are inherently compliant from the outset, which reduces the risk of future breaches. These experts bring valuable insights into the complex legal landscape and assist in navigating potential compliance challenges.
Establish clear contractual agreements with your EHR vendor that outline compliance responsibilities and expectations. These EHR system requirements should specify the vendor’s obligations regarding data security, system updates, and regulatory adherence.
If you are unsure which EHR to select, contact us at (661) 384-7070, and our experienced team will guide you in making an informed decision.
