The Impact of the Pandemic Accelerates the Need for Robust Regulation and Certification in Telehealth Services.
The landscape of healthcare delivery has undergone a seismic shift with the surge in telehealth services, a transformation hastened by the global pandemic. In response to the evolving needs of this digital frontier, ISO 13131:2021 has emerged as a crucial standard, setting the stage for quality planning guidelines in the realm of telehealth services.
Telehealth Boom: A Paradigm Shift in Healthcare
The statistics speak volumes - nearly half of healthcare users in the US turned to telemedicine during the pandemic, a sharp rise from one in 10 users in 2019. The UK experienced a similar trend, with six in 10 appointments conducted via telephone in mid-July 2020. While healthcare is governed by an extensive array of ISO standards, the telehealth sector lacked comprehensive regulation until recently.
Evolution of Standards: From ISO 13131:2014 to ISO 13131:2021
ISO 13131:2014 laid the foundation as the first standard for telehealthcare, but it was ISO 13131:2021, updated last year, that brought a new level of sophistication. This standard, titled "Health Informatics – Telehealth Services – Quality Planning Guidelines," reflects the industry's need for stringent regulation as telehealth services become increasingly integral to patient care.
Navigating the Telehealth Landscape: Key Areas Covered by ISO 13131:2021
The updated standard addresses critical facets of telehealth, ensuring comprehensive quality planning. Key areas covered include the management of telehealth quality processes, strategic and operational processes, healthcare processes, financial resources, information management and security, and processes related to human resources, infrastructure, facilities, and technology resources.
The Timely Nature of ISO 13131:2021
The updated standard aligns with the unexpected surge in telehealth usage during the pandemic. While the changes from the 2014 version are not revolutionary, the standard's evolution signifies its responsiveness to the dynamic landscape of telehealth.
Addressing Challenges: Risk Management and Governance
The need for robust regulation in telehealth platforms is underscored, emphasising security, data management, and clinical governance. ISO 13131:2021 prompts healthcare providers to ask critical questions about the platform's clinical governance, risk management, and adherence to protocols. It introduces specificity regarding risk management, governance, control, and quality planning, aiming to minimise the unique risks associated with telehealth consultations.
Certification Surge and Future Outlook
The certification to ISO 13131:2021 has witnessed a surge, driven in part by major health insurers grappling with the implications of telehealth services. There is a growing trend where companies seek certification to assure the quality and safety of telehealth services. The process, spanning a minimum of 9-12 months, involves a baseline analysis gap, ensuring that organisations align their quality systems with the stringent requirements of the standard.
A Unified Question Across Medical Standards
In conclusion, all medical standards converge on one fundamental question: How are healthcare providers assuring the quality and safety of care for patients? ISO 13131:2021, with its specificity tailored to the nuances of telehealth, emerges as a pivotal tool in answering this question, ensuring the industry's commitment to delivering secure, high-quality telehealth services.
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