Table 2.
Description of themes for DHT-HTA framework by experts from the online survey – a qualitative synthesis from seventeen participants
| Domains | Themes | Description of themes | Weightage (Qualifier) |
|---|---|---|---|
| Description of a digital health technology (DHT) | Electronic health data | Electronic medical records, medical history information, disease/health informatics, mHealth, hospital data, public health data | 11 (3+) |
| Real-world data in digital forms | Automated health information, Virtual devices, Sensors, robotic devices, artificial intelligence/machine learning applications, medical/diagnostic/prognostic devices, health software/Apps | 4 (1+) | |
| Decision-making tool | Use the expertise of health specialists/clinicians, facilitate evidence generation, aid in the prevention and management of medical conditions, support decisions | 8 (2+) | |
| Improve access and healthcare delivery | Coverage (improve access in rural settings), limited health infrastructures, online consultation, telemedicine services, app-based health interventions | 7 (2+) | |
| Effectiveness and safety | Intrinsic safety of devices, extrinsic ability of technologies to drive safety, Resource mapping, feasibility, technology, and digital intervention uptakes, the safety of interventions, clinical and cost benefits/impacts | 8 (2+) | |
| User engagements | End-user information, patient feedback, health expert feedback (clinician, community workers), prioritized health issues | 4 (1+) | |
| Ethics and digital clinical safety | Data security, privacy, medical ethics | 3 (1+) | |
| Remote monitoring | Virtual consultations, telemedicine services, 24-hour support | 4 (1+) | |
| DHT assessment framework for India | Selection of problem | Choosing a DHT problem, Evidence gap mapping, objectives of DHT, Primary and secondary data usage, Contextual factors | 8 (2+) |
| Selection of comparator | best available supportive care, based on clinical effectiveness, pre-post intervention, safety profiles, cost-effectiveness, ethical, governance, implementation, monitoring, acceptability, ease-of-use, exposed versus non-exposed, latent class modeling (internal gold standards) | 13 (4+) | |
| Choosing a theoretical framework | Theories of planned behavior, Culture and value theory and flow experience theory, unified theories of acceptance and technologies | 2 (1+) | |
| Technical components | Flexibility and adaptability, Testing of AI/ML algorithms, Use of primary and secondary data, and emerging digital technologies as they become available | 3 (1+) | |
| Costing of technologies | Cost, Under and over-reported costs, Third party engagements, access issues | 6 (2+) | |
| Data storage and privacy | Confidentiality, Standards, the data protection policy (misuse), data security, data hacking | 8 (2+) | |
| Ethics, evidence, and safety | Transparency, outputs and outcome, impacts, patient safety issues, patient rights, autonomy | 9 (3+) | |
| Regulatory frameworks | National-level body for DHTA, Devices for regulating digital diagnosis, prevention, monitoring, supporting life, use of software and apps in health | 4 (1+) | |
| Collaboration and end-user participation | Developers, end-user, policymakers, clinicians, and advocacy groups, accessibility, usability, technical reliability, accuracy, and integration of digital health technologies | 14 (4+) | |
| Challenges for health providers in adopting digital technologies | Time constraints | Lack of sufficient time, resistance to change management, redundancy | 7 (2+) |
| Resource constraints | Financial capability, trained manpower, infrastructure costs, electricity, internet, skill training, repairs | 7 (2+) | |
| Training and skill building | Technical know-how, training and support, a regulatory framework that addresses data privacy and security concerns | 5 (2+) | |
| Rapid changes in technologies | Rapid changes in technologies (e.g., constantly changing point of care) | 4 (1+) | |
| Acceptance from patients | Lack of knowledge, mistrust, superstition, cultural appropriateness, political will, and capacity to use | 4 (1+) | |
| Information from the producer of technology | Product development and testing information | Situation and needs for new technologies, technical information (blueprints), components used, testing information or trials, social and health impacts, development process | 11 (3+) |
| Regulatory applications and approvals | Intellectual property, compliance to standards during product development, company history, product costing and financial information, quality, and safety of components used | 8 (2+) | |
| The business model of the company | Competitor information, the business model of product/company, revenue model, manpower requirements, company headquarters, director info, shareholding pattern, tax returns, ownership of the company, healthcare industry partners | 14 (4+) | |
| Data management and quality assurance protocols (SOPs) | Capability and skillsets of end-users, data standards, data storage policy, the process of storage and duration of storage (how long in the case of images), data collection and management protocol (SOPs) | 12 (3+) | |
| Data security protocol | Server location, type, and security standards Required technical rigor, Consistency, and privacy maintenance measures | 13 (4+) | |
| Framework for classifying risk | Risk classification of digital products | Need to classify digital health interventions/products based on their potential risk to patients/end-users | 15 (4+) |
| End-user feedbacks | User satisfaction and experience, to improve quality and safety, evaluate patient satisfaction levels, best practices on electronic health records | 12 (3+) | |
| Automated real-world data (IOT based or sensors) | Monitoring vital signs, tracking physical activity, assessing sleep patterns, managing chronic conditions, Identifying environmental hazards, intensive care units, hospital wards, GP offices, lab equipment, dental practices, and in-home care products | 4 (1+) | |
| Assessment Framework for clinical effectiveness | Clinical benefits | Patient outcomes, Life years saved (QALY and DAKY), accuracy and precision, time saved and ease of processes (monotonous processes that could be quickened), early diagnosis, end-user acceptability, single-arm studies or real-world data, continuous data on individuals and populations, clinical pathways and practice guidelines | 14 (4+) |
| Cost benefits | Direct: Labour/HR cost, Production cost, Material cost (components), Manufacturing & supply cost, development and implementation costs, maintenance and support costs, training costs, operational costs, direct and indirect medical costs, out of pocket expenses, capital cost and noncapital cost, health expenditure, cost of storage, cost of device and delivery, transport cost, marketing cost, uptake cost, and maintenance cost, packaging cost, and R&D cost | 17 (5+) | |
| Indirect: Loss of productivity, absenteeism, caregiver costs, loss of income, accessibility cost, equity cost, annual maintenance, insurance, cost of patent (IP rights), technology failures, maintaining web portals/apps, time and travel costs, intangible costs, environmental costs, administration and support, office and equipment rental costs, and investment write-offs | 14 (4+) | ||
| Adverse events | Improper use, wrong interpretation of the results (human errors), risk assessments, evaluate mitigation strategies, materio-vigilance programs, deep learning AI enables the identification of AE patterns that may not be easily recognizable by humans | 9 (3+) | |
| Biases in Digi HTA | Selection bias, expertise of users, environmental issues (temperature, storage conditions, power source, etc.), conformity bias, gender bias, recall bias, reporting bias, algorithm bias | 10 (3+) | |
| Technology readiness levels (TRL) | Ensure safety, assess the feasibility, effectiveness, and impact of digital health interventions | 6 (2+) | |
| Contextual information | Adaptability in the Indian context, Cultural, language, and social aspects, accessibility to rural and remote populations, ease of use, availability, and affordability | 12 (3+) |
Note: Types of digital health technologies considered are digital therapeutics, patient monitoring/remote monitoring, medical devices (diagnostic and therapeutic), wearables (assisted living), biometric sensors, smartphone-based applications, clinical/diagnostic tools, virtual assistance and telemedicine, personal health, electronic health records, web programs, and disease/health management applications.