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Boston MedTech Advisors BlogJanuary 2024

Digital Health Technologies (DHT) are systems that use computing platforms, connectivity, software, and/or sensors, for health care and related uses. As innovative digital technologies emerge, their use in healthcare is expanding. They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (devices, drugs, and biologics). They may also be used to develop or study medical products.

DHTs have revolutionized the ability to remotely acquire and analyze clinically relevant information such as biomarkers, vital signs, sleep, and performance of activities of daily living through either passive monitoring or active interaction with patients outside healthcare settings (e.g., home, school, work, outdoors). Some DHTs may also facilitate the collection of information from participants who are unable to report their experiences (e.g., infants or cognitively impaired subjects).

In December 2023, FDA released a new final guidance on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” which outlines recommendations to facilitate the use of DHTs in clinical investigations as appropriate for the evaluation of medical products. This guidance builds on the 2021 draft guidance by the same name.

Not all DTHs for use in a clinical investigation meet the definition of a medical device, defined by the Federal Food, Drug, & Cosmetic Act Section 201(h) as: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).

DHTs that meet the definition of a device are subject to design control requirements to ensure that the device being designed will perform as intended. However, DHT that has marketing authorization may only be appropriate for use in specific clinical investigation, depending on their specific context of use (i.e., a statement that describes the way the medical product development tool is to be used and the purpose of the use).

Devices intended only for use in clinical investigations are typically exempt from premarket clearance or approval if the investigation complies with applicable requirements under 21 CFR part 812 (Investigational Device Exemptions). In these cases, the activities needed to ensure that devices will perform as intended in the clinical investigation can vary depending on the device and its specific function, including its context of use.

DHT used in clinical investigations of devices should be ‘fit-for-purpose’ with sufficient level of validation to support its proposed use (involving considerations of both the design and distinct purpose within an investigation). Additionally, the clinical investigation endpoints should reflect the outcome of interest.

As DHT advance and spread rapidly, FDA has released guidance documents on the best approaches to regulate them to ensure safety and effectiveness. In December 2023, FDA released a new final guidance on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,”1 which outlines recommendations to facilitate the use of DHTs in clinical investigations as appropriate for the evaluation of medical products. This guidance builds on the 2021 draft guidance by the same name.2 While the focus of this guidance is on DHTs used for remote data acquisition in a clinical investigation, the recommendations in this guidance may be applicable when DHTs are used by trial participants at a trial site (e.g., continuous glucose monitor reviewed in the clinic).

FDA provides the following considerations for using DHTs in a clinical investigation to help ensure they are fit-for-purpose:

  • Selection of suitable DHTs for use in clinical investigations
  • Description of DHTs in regulatory submissions
  • Verification and validation of DHTs for use in clinical investigations
  • Use of DHTs to collect data for trial endpoints
  • Statistical analysis and trial design
  • Identification and management of risks associated with the use of DHTs during clinical investigations
  • Retention and protection of data collected by DHTs
  • Roles of sponsors and investigators related to the use of DHTs in clinical investigations

In comparison to the 2021 draft guidance, the scope of the guidance has expanded, with the definition of what DHT encompasses, including software applications (i.e., mobile apps) and wearables. FDA emphasizes that a DHT is defined by its function, similar to how FDA views software products.

The following are some of the main sections of the final guidance that include changes from the 2021 draft guidance:

  1. Regulatory considerations
    • Clarification of when investigational device exemption (IDE) or investigational new drug (IND) applications, as they pertain to DHT, would be required.
  2. Use of DHT in clinical investigations
    • “Technical and Performance Specifications” section added to help identify if the device can be considered “fit-for-purpose” based on minimum specifications.
    • “Use of a Participant’s Own DHT and/or Other Technologies” section is simplified and evaluates the advantages and disadvantages of this approach (e.g., subjects use their own smartphone in a study).
  3. DHT description in a submission
    • Addition that the sponsor should describe the flow of data from the DHT to the first durable electronic data repository.
  4. Verification, validation, and usability evaluations of DHT
    • “Further Considerations for Verifying and Validating DHTs” section, includes two additions:
      • Confirming that measurements across different makes and models of DHT are consistent where different products are to be used in a trial.
      • Evaluating and justification of potential differences in remote and in-clinic data capture when using the same DHT device.
    • Revised usability recommendations to include reference to the 2016 FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices”3 and emphasized the need to include assessment of ability of participants to use DHT in remote setting. Such usability testing ensures the proper use of DHT so that measurements obtained by DHT in remote settings are accurate and precise, and supports the accuracy, completeness, and consistency of measurements as well as ongoing engagement of participants.
  5. Statistical analysis and trial design
    • Updated considerations, including emphasis that the same method for collection of data should be used in all study arms; when non-inferiority trial designs may not be appropriate; and importance of a plan to reduce and handle missing data.
  6. Record protection and retention
    • Clarification on FDA inspections (e.g., FDA does not intend to request machine or raw data that requires further processing to be understood, such as voltage).
    • References a new, final guidance4 for information on FDA regulations for clinical investigation records.
  7. Other considerations
    • Addition of end-of-study closeout procedures for Sponsor responsibilities when developing for DHT studies.
    • Clarification that FDA does not expect continuous monitoring of DHT data, unless clinically necessary.
    • Clarification on training subjects in DHT use, including confirmation that use of the device will be restricted to the trial subjects and/or caregivers to ensure validity.

DHT allows for greater inclusion and data collection on patients that provide critical real-world data and facilitates clinical trial experiences. While not all DHT may be medical devices, and many are likely low risk, their increased use in the development of medical devices and drugs warrants careful selection and use of such technologies to ensure they fit-for-purpose. FDA’s new final guidance includes many clarifications to help investigators with the selection, verification, and validation of tools that are critical in bringing new devices and drugs to market in a rapidly developing area. Manufacturers should engage early with FDA to discuss the use of DHTs in a specific clinical investigation.

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  1. Guidance for Industry, Investigators, and Other Stakeholders “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” December 2023.
  2.  Draft Guidance for Industry, Investigators, and Other Stakeholders “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” December 2021.
  3. Guidance for Industry and Food and Drug Administration Staff “Applying Human Factors and Usability Engineering to Medical Devices” February 2016.
  4. Draft Guidance for Industry “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers” March 2023.

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