Were you aware that the moment the IS staff plugs a USB connector into a medical device to send data from it to another device, the organization could become the manufacturer of a completely new medical device and subject to recently announced Medical Device Data System regulations from the FDA? Were you aware that devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use are considered an MDDS product and thus governed by the FDA? Well if you didn’t know, you are not the only one as neither did I until attending the latest New England HIMSS (NEHIMSS) Monthly Event and Social Tuesday evening at the Papa Razzi in Wellesley, MA. Rick Hampton did a phenomenal job of running through the rules and regulations surrounding “Integration of HIT & Medical Devices.” Rick is a Clinical Engineer who has helped write several international standards, including the latest on risk management of integrated HIT and medical networks. He works for Partners HealthCare as their Wireless Communications Manager.
Rick outlined the trend in increasing attention being paid to HIT integration efforts over the past few years. The latest are new FDA rules from February 15, 2011, which specified “Medical Device Data Systems are 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.” He then discussed how the new standard, IEC 80001-1, was written to help hospitals perform proactive risk management when creating these integrated systems.
Currently, Electronic Health Records (EHRs) are granted an exception from being considered a medical device, however one might anticipate the day when they are considered as such and are regulated the same as a Laboratory Information System (LIS) or Radiology Information System (RIS). For an interface analyst such as myself, the implications are that there will be liability in the exchange of unsolicited results (for instance) between the LIS and the EHR. For those Allscripts users, this also brings into question the applicability of the regulations on the Allscripts Universal Application Integrator (UAI), which provides Allscripts Enterprise EHR the ability to interface with third party applications. An example would be a Welch Alynn Vital device.
A great question was posed from a HIT project manager in the audience who inquired about where this all fits in the scheme of all of the potentially competing projects in the enterprise (HIPAA 5010 EDI, ICD10 and MU come to mind), and also, where does it come into play in terms of the project to get the necessary departments together to discuss compliance? Often times the clinicians, end-users or decision-makers have already procured the software/solution/system and simply hand-off to IT to implement, and unfortunately it is too late by that point to perform the necessary risk assessment and ensure compliance.
Additionally, Rick provided a great link for organization’s to participate in the AAMI/ACCE/HIMSS Risk Analysis Survey to ensure compliance. This survey is intended to obtain baseline information from healthcare delivery organizations about the application of risk management during the healthcare technology life-cycle (eg. acquisition, deployment, use, modification and retirement).
On a side note, this was my first NEHIMSS meeting which I attended as a member. The group has historically been very gracious in allowing non-members to attend free of charge, but to me it made sense to invest $30 for a chapter membership (essentially a drop in the bucket). Not only do I get great exposure to topics and presentations I normally wouldn’t have access to, but I also get the opportunity to network and form contacts with fellow members of the HIT industry. To me, that is a $30 well spent (by Galen of course ;).
Lastly, for those project managers out there, be sure to register for the 5th Annual New England HIMSS/PMI-NH Project Management Symposium, hosted at the Sheraton Portsmouth Harborside Hotel in Portsmouth, NH. There are some great speakers presenting who will surely offer valuable insight into their experiences with initiatives that directly impact the healthcare organization today (Patient Portal, PM’s role in an EMR implementation, Project Managing a 5010 and ICD-10 upgrade, and HIE implementation to name a few). CPHIMS Credits will be offered for this event as well!