Legal considerations and contractual agreements that apply to tele-ICUs include the fact that the executive leadership is required to incorporate the tele-ICU model of care into the innovative care delivery model. Also, tele-ICU healthcare organizations and professionals in the US must integrate into their services the requirements for privacy and confidentiality as required by the Health Information for Economics and Critical Health Act (HITECH) and the Health Insurance Portability and Accountability Act (HIPAA). Detailed information is below.
- According to NCBI, Tele-ICU is the use of an off-site command center, where a team of critical care practitioners works together to care for critically ill patients in remote bedside ICUs using linked and interfaced health information, data streams, electronic medical records, and audiovisual connections.
- In critical care, around 20% of non-federal adult ICU beds in America today are supported by some form of tele-ICU coverage, as per NCBI. However, the legal and regulatory framework for tele-ICUs has moved slower than the clinical adoption of the new care delivery model.
- The Critical Care Explorations journal says that tele-ICU services are increasingly used in the US, with 11% to 20% of ICU beds being monitored by tele-ICUs.
- The factors driving tele-ICUs in the US are technology improvements, workforce shortages, and demographic changes related to age. It was also discovered that the care of ICU patients by dedicated intensivists improves patient and cost outcomes also prompted the use of Tele-ICU’s.
- According to Grand View Research, the global tele-ICU market size is forecast to reach $6.1 billion by 2026, growing at a CAGR of 16.7% over the forecast period.
- The American Telemedicine Association (ATA) collaborated with the ATA TeleICU Practice Guidelines Work Group and the ATA Practice Guidelines Committee to research, write, and develop guidelines for tele-ICU services. The guidelines are below:
- The first guideline states that professional entities that provide and receive tele-ICU services shall follow the standard administrative and operating policies and procedures of the governing organization agreed upon
- Besides, the executive leadership is required to cultivate a shared vision of incorporating the tele-ICU model of care into the innovative care delivery model. The administration should clearly articulate the vision throughout the entire organization.
- The executive leadership must ensure that tele-ICU clinical leaders are appropriately positioned within the organization to participate in key decision-making forums with the authorities to make necessary decisions. Also, policies and procedures shall show that tele-ICU roles are integrated into the critical care team, including quality assurance processes and sentinel event review.
Human Resource Management Guidelines
- The organization is required to produce guidelines that specifically describe tele-ICU roles and responsibilities, relevant staffing models, hours of operation, communication methods, routine and emergency care delivery procedures, and chain of command for escalation processes.
- The guidelines should match the needs of the patient population and bedside healthcare staff. Also, each organization should support orientation, staff development, and competency of tele-ICU programs.
Health Professionals: Regulatory Consideration
- Tele-ICU professionals shall be registered, fully licensed, and credentialed with their respective regulatory, licensing, and accrediting agencies and with consideration to legislative, administrative, and regulatory requirements of the site where the healthcare professional and patient are located. All federal and state regulations regarding prescriptive authority shall be considered and shall be updated as changes occur.
- Healthcare professionals are required to be aware of their locus of accountability and all requirements, including those for liability insurance, that are applicable when providing tele-ICU services.
- Tele-ICU healthcare professionals may be required to negotiate with local facilities for exemption from certain obligations in the facilities’ regulations and bylaws, such as ER call, TB testing requirement, and non-ICU related committee meetings, while providing tele-ICU services.
- Healthcare professionals providing tele-ICU services shall have the necessary clinical preparation, orientation, ongoing education, and professional development to ensure they possess the required expertise to promote quality care and patient safety.
Privacy and Confidentiality
- Tele-ICU healthcare organizations and professionals in the US shall integrate privacy and confidentiality requirements as expected by the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information for Economics and Critical Health Act (HITECH).
- Additional state regulations shall be followed for privacy, confidentiality, and patient rights, above and beyond requirements in place for general health care interactions.
- Tele-ICU services provided to patients physically located in other countries shall conform with the privacy laws in effect for that country. Policies and procedures shall address the patient's privacy and security needs from both a technological and human rights perspective. Examples include processes to protect patient privacy during remote video assessment.
- Organizations providing tele-ICU services shall create policies to maintain patient privacy/confidentiality when visitors from outside of the organization tour the tele-ICU center. All ICU patients and families shall receive information that includes the tele-ICU program's role in patient management, the use of the technology, and how confidentiality is maintained. Some state regulations require consent for telemedicine consultations, and these shall be included as part of the organizations' general consent process.
- Organizations are required to create a budget that includes the cost of implementing tele-ICU services, such as hardware, software, licensing fees, data lines, credentialing fees, supplies, personnel, and real estate.
- The budget should also include ongoing expenses related to the program's maintenance, such as hardware and software upgrades, staff education, and equipment replacements. The budget should also identify current and projected future revenue for operating the tele-ICU services.
- Revenue items may include private contributions, payer reimbursements, grants, and general support from the healthcare facility and or healthcare system.
- Organizations may consider a financial model that addresses possible enhancement or expansion of the tele-ICU services. Customized fiscal metrics should reflect the goals of the individual tele-ICU program and require regular reevaluation at the executive level.
Management of Patient Records
- The tele-ICU should use processes and policies for documenting, storing, and retrieving health records consistent with the organizational, industry, and governmental standards.
- Interworking should be prioritized to ensure the effortless flow of information between patient information systems to enhance clinical support and promote continuity of care. Direct interfaces between the tele-ICU and hospital electronic medical records, laboratory, pharmacy, and bedside monitor system represent the highest standard of interworking.
- The organization shall establish policies and procedures regarding clinical documentation that originates from the tele-ICU in compliance with organizational legal and risk management oversight.
- The documents shall clarify the tele-ICU clinical intervention and a complete clinical picture based on the available data in the tele-ICU integrated into the permanent record.
Patient Rights and Responsibilities
- Patients and families shall be informed and educated about the role of the tele-ICU in the integrated care delivery model. The use of remote care healthcare professionals and audio/visual technology shall be included as part of tele-ICU specific patient education.
- Healthcare professionals should be particularly thoughtful with the use of audio/visual technology to provide patient/family privacy and sensitivity to cultural considerations. It may include appropriate language translation services for patients and families.
- Apprehensions regarding the role of the tele-ICU and or components of the audio/visual technology should be addressed collaboratively with the patient/family, the tele-ICU, and the bedside team and may be addressed through organizational policies.
Quality and Outcomes
- Tele-ICU services shall put in place a systematic quality improvement and performance management process that complies with all organizational, regulatory, or accrediting requirements.
- The quality indicators shall include the administrative, technical, and clinical components for the provision of tele-ICU services. They shall be used to make technical, programmatic, and clinical changes based upon the best new evolving technology, practice principles, evidence-based guidelines, and clinical research or changing service requirements.
- Tele-ICU administrators, staff, and ICU healthcare professionals should align to meet specific program outcomes and process measures.
- The organization should clearly define the process used to report and disseminate quality metrics and outcomes for operational and administrative staff analysis.
- Research involving the tele-ICU’s contributions to patient care and clinical outcomes should be encouraged and supported by the organization.
- Such research opportunities shall be in compliance with the organization’s IRB approval process.
- The organization should decide the physical layout and ergonomics of the tele-ICU and ICU suites early in the planning process. The decision should include input from clinicians, technology engineers, and physical plant engineers.
- Architectural design should consider communication essentials between and among tele-ICU team members and the ICUs.
To provide an in-depth overview of the legal considerations and contractual agreements that apply to tele-ICUs, we leveraged information from industry reports and databases, such as the American Telemedicine Association and journals like the NCBI. We found a report with guidelines for tele-ICU written by the American Telemedicine Association in collaboration with the ATA Tele-ICU Practice Guidelines Work Group and the ATA Practice Guidelines Committee. The guidelines were published in 2014, and the source is for the same year. We used the source as it is credible, and we did not find any newer versions of the guidelines.