Interface Feeds and EMR Compliance
This was asked and answered by Lance Borders on LinkedIn.
Has anyone heard that the FDA will require inbound/outbound interface feeds to the EMR be compliant?
FDA Issues Final Rule for
Medical Device Data Systems
Tuesday, March 15, 2011
In the February 15 Federal Register, the Food and Drug Administration
(FDA) released a final regulation on how it will regulate “medical
device data systems” (MDDS). The FDA defines MDDS as “off-the-shelf or
custom hardware or software products used alone or in combination that
display unaltered medical device data, or transfer, store or convert
medical device data for future use, in accordance with a preset
specification.” Examples of MDDS products include devices that collect
and store data from a glucose meter for future use and devices that
transfer lab results to be displayed at a nursing station for future
The FDA makes clear that the rule applies to hospitals and other health
care providers that create their own software protocols or interfaces to
transfer data from a medical device, as well as medical device
manufacturers and third-party software vendors. Thus, custom solutions
developed to feed data from a medical device to another data system,
such as an electronic health record (EHR), could be considered MDDS and
fall under FDA regulation. Data systems that are sold as an integral
part of a medical device are not considered MDDS, but are regulated as
part of the device.
The FDA has classified MDDS as Class 1 devices, the lowest level of FDA
regulation. Follow the link to learn FDA requirements from hospitals acting as manufacturers as well as MDDS manufacturers at http://edocket.access.gpo.gov/2011/pdf/2011-3321.pdf. <http://edocket.access.gpo.gov/2011/pdf/2011-3321.pdf>
For other questions regarding this rule or compliance with FDA regulations, you may contact
FDA at 1-800-638-2041 or email@example.com. mailto:firstname.lastname@example.org
Here is what I found:
The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements.
DATES: This rule is effective April 18, 2011. See section IV of this document for more information.
Background: A. Medical Device Data System
An MDDS is a device that is intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. An MDDS acts only as the mechanism by which medical devicedata can be transferred, stored, converted, or displayed. An MDDS does not modify the data or modify the display of the data. An MDDS by itself does not control the functions or parameters of any other medical device.
An MDDS can only control its own functionality. This device is not intended to provide or be used in connection with active patient monitoring. Any product that is intended for a use beyond the uses (or functions) identified in this final classification rule is not an MDDS and is not addressed by this rule.
FOR FURTHER INFORMATION CONTACT:
Anthony D. Watson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2516, Silver Spring, MD 20993–0002, 301–796–6296.
One takeaway here is that custom solutions that transfer data from a medical device to an EHR are likely to fall under the FDA regulation.