BIO Submits Comments in Response to FDA Guidance on Digital Health Technologies
March 21, 2022
On Monday, March 21st, BIO submitted comments in response to the recent FDA draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. In the comments submitted, BIO expressed appreciation for the issuance of this draft guidance as it provides greater clarity on FDA’s approach to the regulation of remote data acquisition, which will in turn encourage the use of digital health technologies (DHTs) and methods in product development. To further enhance this Guidance, BIO recommended that the Agency expound on the utility these technologies provide for facilitating better oversight of patients participating in remote studies, while allowing sponsors to collect data that is more relevant to patients’ needs. Additionally, though the Guidance encourages leveraging of prior work in verification and validation of DHTs, which will be critical as the field continues to advance; BIO noted that it does not provide specific evidentiary requirements for verification and validation, nor does it reference an available source as guidance. BIO urged the Agency to address these requirements in its final guidance. Furthermore, while the inclusion of topics such as data collection, storage, and protection in this guidance are helpful to sponsors; BIO encouraged the Agency to provide detail on specific issues like source data management, safeguards to ensure data integrity, expectations for raw data submission, and mitigation strategies for connectivity disruptions. Finally, BIO requested the Agency provide further clarity on how and when sponsors should engage with the various centers at FDA during development of a DHT for remote data acquisition in clinical trials.
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
On Monday, March 21st, BIO submitted comments in response to the recent FDA draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. In the comments submitted, BIO expressed appreciation for the issuance of this draft guidance as it provides greater clarity on FDA’s approach to the regulation of remote data acquisition, which will in turn encourage the use of digital health technologies (DHTs) and methods in product development. To further enhance this Guidance, BIO recommended that the Agency expound on the utility these technologies provide for facilitating better oversight of patients participating in remote studies, while allowing sponsors to collect data that is more relevant to patients’ needs. Additionally, though the Guidance encourages leveraging of prior work in verification and validation of DHTs, which will be critical as the field continues to advance; BIO noted that it does not provide specific evidentiary requirements for verification and validation, nor does it reference an available source as guidance. BIO urged the Agency to address these requirements in its final guidance. Furthermore, while the inclusion of topics such as data collection, storage, and protection in this guidance are helpful to sponsors; BIO encouraged the Agency to provide detail on specific issues like source data management, safeguards to ensure data integrity, expectations for raw data submission, and mitigation strategies for connectivity disruptions. Finally, BIO requested the Agency provide further clarity on how and when sponsors should engage with the various centers at FDA during development of a DHT for remote data acquisition in clinical trials.