Consensus report recommendations

  1. Regulatory agencies should:

    • a. establish and update standards to be met by digital health technology developers at premarketing and postmarketing stages, such as elements of clinically validated information (not necessarily from RCTs), service systems to support users, effectiveness variables to enhance outcomes, and functions to transmit data to other devices, while also supporting market innovation

    • b. provide a regulatory paradigm, such as that outlined by IMDRF, which is tailored specifically to software, taking the short product life cycle and rapid turnover of updates into account

    • c. provide guidance for obtaining and promoting evidence of safety, effectiveness, and other performance measures

    • d. find ways to evaluate the security, accuracy, and reliability of digital health apps (e.g., by recognizing and following the DTSec model), including supporting companies (often small) to generate real-world data when they have a product that has achieved a certain standard

    • e. provide, publicize, and maintain a single publicly accessible international database of available digital health apps and their utility/quality, including harmonizing the parameters that would measure utility/quality and how these parameters would be assessed (84)

    • f. publish an annual summary of regulatory activities

    • g. work to harmonize their activities

 

  • 2. Manufacturing companies should:

    • a. comply with regulations, industry standards, and best practices established for digital health app development and marketing, such as providing a regularly updated flowchart that describes the decision-making process for releasing app updates; a broader plan for software maintenance and testing; and plans for obsolescence for when a specific mobile device model or operating system for which the app has been validated is discontinued (16)

    • b. include sufficient documentation, training modules, and help-desk resources to ensure optimal use

    • c. provide interfaces that are user-friendly across all demographic groups and can be personalized with real-time insights and suggestions for individual users (taking their socioeconomic status into account, especially around health literacy)

    • d. report all safety-related data promptly and transparently to the regulatory authorities

    • e. cooperate with academics and HCPs to provide balanced and adequate information for people with diabetes and package the output data in standardized formats for ease of access in electronic health records

    • f. enable users to opt to submit their data anonymously to track outcomes and demographics following a crowd-sourcing model

    • g. incorporate high degrees of data security and patient confidentiality (e.g., by adhering to the DTSec model)

 

  • 3. International and national professional societies should:

    • a. bring people with diabetes, HCPs, manufacturing companies, and regulatory authorities together to facilitate digital health technology interventions

    • b. encourage academia and medical associations to advance research in digital health app effectiveness, safety, and outcomes

    • c. help set expectations for HCPs and consumers regarding the strengths and limitations of digital technology

    • d. provide evidence-based guidelines on the effectiveness of digital health interventions

    • e. recommend appropriate forms of structured education required for HCPs to support people with diabetes to benefit from the best digital health (HCPs cannot be trained in the use of each app; however, they can be supported in maintaining a basic understanding of what apps can do and how they are used)

    • f. maintain a list of endorsed apps that have passed a threshold of accuracy, dependability, and ease of use for both people with diabetes and HCPs

 

  • 4. International and national research funding bodies should:

    • a. provide or facilitate funding for well-designed independent clinical studies that measure safety, effectiveness, outcomes, and use in real-world settings

    • b. provide or facilitate significant financial support for long-term data collection

 

  • 5. Researchers/academics should:

    • a. openly report and share the patient-level results of all clinical evidence

    • b. develop and validate specific and appropriate patient-related outcome measures

 

  • 6. HCPs should:

    • a. be knowledgeable of digital health apps and their strengths and weaknesses

    • b. support and inform people with diabetes on the use of digital health apps to augment diabetes management and lifestyle modification

    • c. use health data to improve quality of care and health outcomes

 

  • 7. Consumers of digital health apps (people with diabetes, family members, caregivers) should:

    • a. consider digital health apps as a valuable addition or supplement to disease management or prevention

    • b. discuss with their HCPs available and appropriate digital health app options, as well as advice or counseling received from the app that affects behavior or care decisions

    • c. submit app reviews, which would include information on digital health app efficacy, success, errors, and malfunctions, as well as report apps that appear to be unsafe or illegally marketed, to the manufacturers and appropriate regulatory agencies and care organizations (e.g., ADA)

 

  1. Regulatory agencies should:

    • a. establish and update standards to be met by digital health technology developers at premarketing and postmarketing stages, such as elements of clinically validated information (not necessarily from RCTs), service systems to support users, effectiveness variables to enhance outcomes, and functions to transmit data to other devices, while also supporting market innovation

    • b. provide a regulatory paradigm, such as that outlined by IMDRF, which is tailored specifically to software, taking the short product life cycle and rapid turnover of updates into account

    • c. provide guidance for obtaining and promoting evidence of safety, effectiveness, and other performance measures

    • d. find ways to evaluate the security, accuracy, and reliability of digital health apps (e.g., by recognizing and following the DTSec model), including supporting companies (often small) to generate real-world data when they have a product that has achieved a certain standard

    • e. provide, publicize, and maintain a single publicly accessible international database of available digital health apps and their utility/quality, including harmonizing the parameters that would measure utility/quality and how these parameters would be assessed (84)

    • f. publish an annual summary of regulatory activities

    • g. work to harmonize their activities

 

  • 2. Manufacturing companies should:

    • a. comply with regulations, industry standards, and best practices established for digital health app development and marketing, such as providing a regularly updated flowchart that describes the decision-making process for releasing app updates; a broader plan for software maintenance and testing; and plans for obsolescence for when a specific mobile device model or operating system for which the app has been validated is discontinued (16)

    • b. include sufficient documentation, training modules, and help-desk resources to ensure optimal use

    • c. provide interfaces that are user-friendly across all demographic groups and can be personalized with real-time insights and suggestions for individual users (taking their socioeconomic status into account, especially around health literacy)

    • d. report all safety-related data promptly and transparently to the regulatory authorities

    • e. cooperate with academics and HCPs to provide balanced and adequate information for people with diabetes and package the output data in standardized formats for ease of access in electronic health records

    • f. enable users to opt to submit their data anonymously to track outcomes and demographics following a crowd-sourcing model

    • g. incorporate high degrees of data security and patient confidentiality (e.g., by adhering to the DTSec model)

 

  • 3. International and national professional societies should:

    • a. bring people with diabetes, HCPs, manufacturing companies, and regulatory authorities together to facilitate digital health technology interventions

    • b. encourage academia and medical associations to advance research in digital health app effectiveness, safety, and outcomes

    • c. help set expectations for HCPs and consumers regarding the strengths and limitations of digital technology

    • d. provide evidence-based guidelines on the effectiveness of digital health interventions

    • e. recommend appropriate forms of structured education required for HCPs to support people with diabetes to benefit from the best digital health (HCPs cannot be trained in the use of each app; however, they can be supported in maintaining a basic understanding of what apps can do and how they are used)

    • f. maintain a list of endorsed apps that have passed a threshold of accuracy, dependability, and ease of use for both people with diabetes and HCPs

 

  • 4. International and national research funding bodies should:

    • a. provide or facilitate funding for well-designed independent clinical studies that measure safety, effectiveness, outcomes, and use in real-world settings

    • b. provide or facilitate significant financial support for long-term data collection

 

  • 5. Researchers/academics should:

    • a. openly report and share the patient-level results of all clinical evidence

    • b. develop and validate specific and appropriate patient-related outcome measures

 

  • 6. HCPs should:

    • a. be knowledgeable of digital health apps and their strengths and weaknesses

    • b. support and inform people with diabetes on the use of digital health apps to augment diabetes management and lifestyle modification

    • c. use health data to improve quality of care and health outcomes

 

  • 7. Consumers of digital health apps (people with diabetes, family members, caregivers) should:

    • a. consider digital health apps as a valuable addition or supplement to disease management or prevention

    • b. discuss with their HCPs available and appropriate digital health app options, as well as advice or counseling received from the app that affects behavior or care decisions

    • c. submit app reviews, which would include information on digital health app efficacy, success, errors, and malfunctions, as well as report apps that appear to be unsafe or illegally marketed, to the manufacturers and appropriate regulatory agencies and care organizations (e.g., ADA)

 
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