§ 1021.43. Vendors of EMS patient care reports.
(a) An EMS agency shall submit EMS PCRs as required under § 1021.41 (relating to EMS patient care reports) by using only a software program approved by the Department.
(b) A vendor may not sell or otherwise provide or offer reporting forms or software marketed as appropriate for use in making EMS PCRs unless the vendor submits the product to the Department for review and receives the Department’s approval. This also applies to a substantive modification the vendor makes to the reporting form or software. The vendor shall apprise the Department of the modification before marketing the modified form or software regardless of whether the vendor considers the modification to be substantive. EMS agencies may ascertain which vendor products have been approved by the Department under this subsection by contacting the Bureau.
(c) If the Department makes changes to the minimum data elements of the EMS PCR, the Department will publish a notice of the changes in the Pennsylvania Bulletin. The effective date of the changes will not be less than 60 days after publication of the notice.
(d) After publication of the changes, a vendor may not market as appropriate for making EMS PCRs a product that had been approved by the Department prior to the Department publishing the notice of changes, unless the vendor clearly discloses that the forms or software were approved prior to the publication of the changes and may only be used to make EMS PCRs until the changes go into effect.
(e) A vendor may store EMS PCR data on its server for data entry or processing purposes arranged by an EMS agency or a regional EMS council to facilitate the transmission of EMS PCR information among the EMS agency, a receiving facility and the regional EMS council, but may not transmit or provide access to that data to any other entity, except the Department, and may not use the data for any other purpose.
Cross References This section cited in 28 Pa. Code § 1031.15 (relating to discipline of vendors of EMS PCR software).
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