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▶ Mandatory Informed Consent
Healthcare providers must obtain from patients and other subjects written consent concerning the pre-entry program after providing a thorough explanation of the purpose of use, procedural methods, treatment costs, and potential adverse events/side effects, etc.
▶ Usage Reporting Requirements
Mandatory reporting of usage of pre-entry health technologies during the permitted duration designated by official notification.
▶ Extended Assessment Deferral Period (2+2 System)
For health technologies designated as deferred assessment technology, providers may request for a one-time, two-year extension 30 days prior to the expiration of the initial two-year period.
▶ Expanded Scope of Deferred Assessment Subjects
The scope now includes in-vitro diagnostics, genetic tests, and non-invasive diagnostics and health technologies.
▶ Retroactive Application
These revisions to the provisions will also apply retroactively to existing health technologies already designated as pre-entry health technologies.
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