This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:

 — management of telehealth quality processes by the healthcare organization;

 — strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;

 — healthcare processes relating to people such as healthcare activities, planning, and responsibilities;

— management of financial resources to support telehealth services;

— management of information management and security used in telehealth services;

— processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.

This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.

This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.

Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.

• Application of store and forward telemedicine in the identification and management of middle ear disorders in a rural cleft care program:

This program was conceptualized to devise a grassroots-level strategy to identify individuals with middle ear diseases (MEDs) in the rural community using a telemedicine approach. MEDs among individuals with CLP was identified using store-and-forward video otoscopy, hearing status was assessed using synchronous pure tone audiometry and tympanometry for those identified with tympanic membrane (TM) and MEDs and provided with tele-diagnostic confirmation of ear and hearing status.

Community workers scheduled home visits in the community to perform store-and-forward (asynchronous) video otoscopy using a video otoscope integrated with an android mobile phone. Community workers documented each patient’s demographic details and ear and hearing history using the customized mobile application “Shruti”, which was available in the local language, Tamil. The community worker then captured the image of the TM and ear canal using the video otoscope. The obtained image, along with patient data and history, was then uploaded to the cloud using mobile data Internet. The Audiologist viewed the images at the back-end (at the tertiary care hospital) using the Clickmedix platform. This platform has unlimited cloud storage and provides an interface for the audiologist to access the demographics details, patient history, and the images captured by the community worker in the rural community to provide appropriate recommendations.

The audiologist periodically viewed the data and, when necessary, could export the data or share patient data using the same platform in an encrypted format to the otolaryngologist for recommendations on appropriate management. Those with impacted cerumen were recommended cerumen management (using Soliwax solution) based on the Otolaryngologist’s advice. The community worker repeated video otoscopy subsequently to ascertain the status of the middle ear. Those identified with MEDs by the Otolaryngologist were recommended an appropriate medication or a surgical intervention. Prescriptions were mailed to the community workers, who hand-delivered them to the patients. The community workers subsequently followed up to repeat video otoscopy.

The audiologist at the tertiary care hospital conducted pure tone audiometry and tympanometry tests synchronously by remotely accessing the equipment at the rural community. In the case of pure tone audiometry testing, noise levels were measured in the test environment before each testing using a mobile application (BOSCH iNVH). Tympanometry preceded pure tone audiometry testing. The community worker selected an appropriate ear tip and placed the probe in the individual’s ear. The audiologist remotely assessed the accuracy of seal and initiated the testing. The audiologist provided counseling via video conferencing regarding hearing status and appropriate management options. Finally, follow-up compliance for intervention was documented to evaluate the usefulness of telemedicine approach.

• Implications of using telemedicine approach in reaching rural communities

1. In 2011the community-based hearing screening programme for infants and young children was implemented with real-time remote diagnostic ABR conducted in the rural community. We found an improved follow-up compliance for tele-diagnostics (90% follow-up) which resulted in cost saving per child tested.

2. From 2017 onwards we implemented the telemedicine approach in the identification and management of middle ear disorders in a rural cleft care program. In this program, a 55% improvement in diagnosis and management was obtained post implementation of telemedicine approach.