Which of the Following Laws Regulates Electronic Health Records?

Protecting Patient Privacy: The Laws and Regulations Safeguarding Electronic Health Records

Electronic health records (EHRs) contain some of the most sensitive personal information about patients. Protecting the privacy and security of this data is paramount, which is why EHRs are governed by a complex set of laws and regulations. This article provides an in-depth look at the key legal frameworks regulating EHR security.

Are Your Electronic Health Records Secure? Understanding the Laws that Protect Them

The security of EHRs is critical to preserving patient confidentiality and ensuring high-quality care.

A breach of EHR security can expose private health details, cause irreparable damage to patient trust, and disrupt delivery of care. As EHR adoption has increased, so has the need for robust laws and regulations to safeguard these systems.

There are two foundational laws that establish standards for EHR security in the United States - the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act. Additional legislation, regulatory bodies, and ethical considerations shape EHR security requirements.

HIPAA Security Rule

The HIPAA Security Rule is one of the most influential regulations governing EHR security. Finalized in 2003, this rule operationalizes the protections in the HIPAA Privacy Rule by addressing the technical and administrative safeguards required to secure electronic protected health information (ePHI).

Overview and Requirements

The HIPAA Security Rule mandates that covered entities implement appropriate safeguards to ensure the confidentiality, integrity, and availability of ePHI. Key requirements include:

• Administrative Safeguards: Policies, procedures, and training to manage the selection and implementation of security measures and workforce security practices.
• Physical Safeguards: Protection of electronic systems, equipment, and the facility housing ePHI from unauthorized access.
• Technical Safeguards: Software, data, and other technology mechanisms that control access to ePHI and protect its transmission over networks.
• Risk Assessment: Regular analysis of security threats and vulnerabilities to ePHI and implementation of protections against identified risks.
• Scalability: Flexibility in security measures based on size, complexity, and capabilities of the organization.
• Documentation: Creation and retention of written policies, activities, risk analyses, and other evidence of compliance.

Covered entities must comply with all standards and addressable implementation specifications of the Security Rule. An organizational risk analysis guides which security measures are reasonable and appropriate.

HITECH Act

The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the 2009 economic stimulus package, had a major impact on EHR security.

Extension and Enforcement

The HITECH Act extends core HIPAA rules to business associates of covered entities. It also establishes stricter civil monetary penalties for noncompliance. Key provisions include:

• Business Associate Liability: Business associates and subcontractors directly subject to HIPAA Security and Privacy Rule requirements.
• Breach Notification: Organizations must inform patients of breaches of unsecured protected health information.
• Tiered Penalties: Violations categorized into four tiers with fines from $100 to $50,000 per violation to a maximum of $1.5 million per year.
• State Attorney Authority: State attorneys general granted authority to bring civil action for HIPAA violations.

Under the HITECH Act, business associates are now equally responsible for EHR security, and the risks associated with noncompliance are much greater.

Regulatory Bodies and Certification

Governmental and non-governmental organizations play key roles in regulating EHR systems and enforcing security standards.

Accountability and Certification

• The HHS Office for Civil Rights (OCR) enforces the HIPAA and HITECH regulations, investigating complaints and conducting audits.
• The Office of the National Coordinator for Health Information Technology (ONC) oversees EHR certification programs to ensure compliance with standards.
• The National Institute of Standards and Technology (NIST) issues recommended EHR security guidelines.
• Covered entities must conduct annual risk analyses of their EHR systems and update as needed when security configurations change.
• ONC certification confirms an EHR system meets requirements for functionality, interoperability, and security.

Regulatory bodies hold organizations accountable for properly securing EHRs, while certification programs validate EHR security capabilities.

Compliance and Penalties

Adhering to EHR security regulations is compulsory for covered entities and business associates. Violations can lead to substantial financial penalties.

Security Standards and Compliance Dates

• The HIPAA Security Rule establishes national standards for protecting ePHI in electronic form.
• It applies to healthcare clearinghouses, payers, and providers who conduct electronic transactions.
• Covered entities were required to comply with the Security Rule by April 2005. Some provisions have more recent deadlines.
• The OCR enforces the Security Rule standards and conducts periodic audits.
• All noncompliance is evaluated on a case-by-case basis for the penalty amount based on level of negligence.

Recent Large Penalties

• 2018: $16M Anthem settlement for data breach impacting 79 million people.
• 2022: $ 4.2M Kalispell settlement for unauthorized email and internet access.
• 2022: $ 63.5M Miraca Life Sciences settlement for unaddressed security risks.

Covered entities that fail to adequately secure EHRs face substantial financial repercussions, especially with recent major breach settlements.

ONC and CMS Regulations

In addition to HIPAA and HITECH, regulations from ONC and the Centers for Medicare and Medicaid Services (CMS) govern EHR requirements.

EHR Incentive Programs

• The HITECH Act expanded ONC's role to enhance health IT utilization.
• CMS regulations shape EHR criteria for receiving payments under Medicare incentive programs.
• Providers must demonstrate their certified EHR technology (CEHRT) meets interoperability and information blocking rules.
• Attestations and reporting confirm compliance with CMS information exchange and data portability requirements.

Regulations from ONC and CMS ensure optimal EHR functionality and interoperability, facilitating effective use and exchange of electronic health data.

Ethical Priorities and Ownership

EHR security involves balancing implementation of safeguards with ethical obligations related to health data.

Privacy, Confidentiality, and Security

• HIPAA makes organizations accountable for employees' privacy and security practices.
• EHR systems must preserve confidentiality, integrity, and availability of health records.
• Strict access controls, encryption, auditing, and monitoring help prevent unauthorized use.
• Patients have rights to access their records, maintain copies, and view audit logs.
• The medical record itself is legally owned by the healthcare organization, not the patient.
• Privacy, confidentiality, security, and data integrity are key ethical priorities for EHR safeguards.

Audit Logging

• The HIPAA Security Rule mandates audit controls to record activity in EHR systems.
• Logs allow examination of access attempts, system actions, and file modifications.
• Audit trails are essential for security monitoring, investigation of potential breaches, and internal audits.

Comprehensive audit logging provides transparency into how health data is accessed while ensuring patient privacy.

Recent Legislation Affecting EHRs

Regulations for EHR technology continue to evolve with new health IT legislation.

• 21st Century Cures Act (2016): Promotes interoperability and information sharing while preventing data blocking. Established new oversight over health IT and certification programs.
• Information Blocking Rule (2020): Implements interoperability provisions of 21st Century Cures Act. Outlines reasonable and necessary activities that do not constitute information blocking.
• CMS Interoperability and Patient Access Rule (2020): Requires expanded patient access to health data and open, standardized exchanges between payers and providers.

These laws shape the future of EHR systems, facilitating more seamless nationwide data exchange while strengthening patient control over their health information.

Conclusion

Robust security standards for EHR systems have developed through legislation like HIPAA and HITECH along with regulations from key government agencies.

Covered entities must implement administrative, physical, and technical safeguards and conduct ongoing risk assessments.

Adhering to EHR security requirements has become progressively more important as breaches can incur substantial financial penalties.

However, legal obligations must be balanced with ethical duties to patient privacy and confidentiality.

As technology progresses, new health IT laws aim to improve interoperability and data access while ensuring the responsible, secure use of electronic health data.