Electronic Health Records: Quality, Challenges, and Precision Care Delivery, and Precision Medicine

Health Care Quality and Electronic Health Record Functionality

  • Health care quality is defined as care that is safe, effective, patient-centered, timely, efficient, and equitable. The Electronic Health Record (EHR) technology facilitates this through specific functionalities:
    • (1) Timely access to patient information.
    • (2) Decision support tools designed for safe and effective care.
    • (3) Patient engagement facilitated by portals and mobile devices.
    • (4) Coordination and management of care delivery.
  • Data integrity is the prerequisite for these improvements in quality. Safety and efficiency are quantifiable metrics in this context.
  • Reducing medication errors is a primary objective of Computerized Provider Order Entry (CPOE) and Bar Code Medication Administration (BCMA) implementations.
  • Clinical decision support systems provide early warnings regarding changes in patient status, allowing medical errors to be averted. These systems also allow for the exploration of various diagnosis and treatment options.
  • Reported benefits of EHR technology include clinical and operational efficiencies in communication, workflow, documentation, and administrative functions.

Financial Implications and Implementation Costs

  • The cost associated with implementation, upgrades, and maintenance remains a significant barrier to EHR adoption. There are five primary financial components:
    • (1) Hardware.
    • (2) Software.
    • (3) Design and implementation assistance.
    • (4) Training.
    • (5) Ongoing maintenance.
  • Physicians in a large private practice can anticipate first-year costs of approximately $233,297\$233,297 for the purchase and implementation of a certified EHR.
  • Hospitals typically spend between $25\$25 million and $10\$10 billion for initial implementation endeavors.
  • Annual maintenance costs represent an additional expense, typically ranging from 18%18\% to 20%20\% of the initial purchase price.
  • Financial planning must account for ongoing training, technical support, and software upgrades. Organizations are also responsible for the costs of internal interfaces and connections to other facilities. Interoperability depends on the incorporation of standards for local, regional, or national EHR development.

Data Integrity and System Reliability

  • Data integrity refers to the accuracy, consistency, reliability, and completeness of stored and transmitted data. It is compromised by:
    • Incorrect information entry.
    • Deliberate alteration of data.
    • Malfunctioning system protections or sudden system failure.
  • Expanding EHR adoption to include multiple entities increases the risk of human error. Poor screen designs that are cumbersome or confusing, combined with a lack of training, lead to entry errors.
  • Critical patient information—including allergies, medical history, and medications—must be validated and updated at every episode of care.
  • Staff should receive education before system implementation, during system changes, and during new employee orientation.
  • Security measures to protect data integrity include audit trails, penalties for fraudulent activities, and detailed policies.
  • System failures, such as broken alerts or incorrect calculations, may not be noticed by users. Interface failures between applications (e.g., between CPOE and the pharmacy system) can lead to medication orders not being received or dispensed, or laboratory orders failing to reach the lab. These issues significantly impact patient care and can lead to data loss or corruption upon resumption of the interface.

Privacy, Confidentiality, and Security

  • Privacy and confidentiality remain major concerns for both professionals and consumers. Automated sharing of health information via EHRs and Health Information Exchanges (HIEs) may lead clinicians to perceive regulatory requirements as restrictive or an invasion of privacy.
  • Clinicians may document care more cautiously to avoid litigation or resist using the EHR altogether due to restrictive access policies.
  • Cybercrimes, particularly ransomware used to steal or lock patient data, expose systemic vulnerabilities and represent a breach of consumer trust.
  • Large-scale systems raise fears of unauthorized use of personal data. Some consumers prefer that sensitive information, such as psychiatric care, never be shared, though this results in critical missing information in medical records.

Standardized Language and Documentation Burden

  • Standardized vocabularies allow for mutual understanding, improved communication, and common data reporting. While billing codes like ICD, DRG, and CPT are common, clinical and nursing languages are often underutilized.
  • Implementation of standardized language is hindered by:
    • Disagreement on specific terminologies.
    • Lack of harmonization between structures.
    • Licensing fees and copyrights.
    • System customization that prevents the application of specific terminologies.
    • Cultural/language barriers and user resistance.
  • Documentation burden is a significant concern, with professionals finding EHR charting frustrating and cumbersome. Research identifies poorly designed flowsheets and assessment data charting as specific issues.
  • Volume of data required for government and organizational compliance increases cognitive workload, which leads to errors and issues with data integrity.
  • Nurses spent 0%0\% of their time on EHR documentation pre-implementation, which increased to 23%23\% post-implementation.

Consumer Access and Data Ownership

  • Barriers to consumer access include the need for system redesign, high financial investment, and the fragmentation of records across multiple facilities. Integrating data from disparate systems is technically difficult and costly.
  • The Health Information Portability and Accountability Act (HIPAA) security rules require administrative, physical, and technical safeguards for electronic protected health information (ePHI).
  • The 21st21\text{st} Century Cures Act proposes specific policies for patient access, including participation in HIEs.
  • Consumers have a legal right to access protected health information (PHI), but often cannot view clinical provider notes or update/correct their own records.
  • Providers express concern that patients may lack the skills to interpret health records, leading to confusion or anxiety. Some providers delay the release of test results until they can be discussed verbally.
  • The concept of ownership is complex; one proposal is to separate "ownership" from "access," where institutions act as data stewards while consumers own the data.

Patient-Generated Health Data (PGHD)

  • PGHD is health-related data created, recorded, or gathered by patients, family, or caregivers. Sources include mobile devices, social media, wearables, genetic testing, and biometric sensors.
  • Healthcare professionals have concerns regarding:
    • (1) Volume and quality of data (information overload).
    • (2) Data usage and clinical pertinence.
    • (3) Privacy and security.
    • (4) User characteristics (literacy level and digital health skills).
  • Risks include patients providing irrelevant details, underreporting or overreporting symptoms, or manipulating data to obtain specific outcomes like prescription medications.

Provider and Organizational Perspectives

  • Physician attitudes have shifted from viewing EHR entry as a clerical task to acknowledging benefits such as improved patient communication and support for preventive care. However, EHRs are also cited as a cause of physician burnout due to a lack of meaningful clincal assistance and time-consuming data input.
  • Nurses report that EHRs increase productivity, decrease medication administration errors, and support evidence-based practice.
  • Healthcare executives view EHRs as tools to improve operational efficiency, support regulatory compliance, and enhance patient safety and care coordination.
  • Implementing EHRs is disruptive to the sociocultural system of an organization. It can alter interpersonal communication and create disruptions in workflow, such as nurses being unaware of new orders until they sign on to the system.

National Economic and Governmental Impacts

  • In 20182018, U.S. healthcare costs exceeded $3.6 trillion\$3.6\,\text{trillion}. The implementation of a nationwide interoperable EHR is a recommended strategy for cost containment, medical error reduction, and quality improvement.
  • A nationwide infrastructure allows for the timely identification of safety issues, notification of populations at risk for disease or environmental exposure, and the detection of epidemics such as COVID−19COVID-19 or bioterrorism attacks.

Precision Care and Advanced Technologies

  • Precision medicine uses big data, genomics, and machine learning to personalize care based on individual variances in genetics and lifestyle.
  • Biobanks are repositories of medical, biological, and genetic material. When linked to EHRs, they allow researchers to uncover new phenotype relationships and identify gene mutations such as BRCA1/21/2 for breast cancer.
  • Genomics and phenotyping enable the development of "designer medications" that target unique individual characteristics, minimizing side effects and eliminating ineffective dosages.
  • Machine learning uses statistical and computational algorithms to map complex relationships between biologic and genotype data. These models predict treatment responses and potential for disease. While EHRs provide data from clinical settings, precision medicine also seeks to incorporate non-traditional sources like PGHD from mobile devices and smart home technologies.