EHR safety
With the incentives towards implementing electronic health records (EHRs) across the nation with meaningful use [1], there has been a renewed interest in to safety. With continued unresolved issues of workflow and usability [2], safety issues remain a concern.
The EHR, clinical decision support (CDS), and CPOE is a software service and not considered a device, thus not regulated by the FDA for safety [3]. Dr. James Walker et. al. write in the viewpoint paper from 2008 provides a framework for the issue and recommends that the following steps should be followed: Use EHRs as tools for health care process improvement, design and implement safe EHRs, improve EHRs through safety testing and reporting, prevent and manage EHR-related incidents, communicate safety flaws and incidents, and develop and communicate EHR safety best practices [4].
An AMIA board position paper published in 2010 discusses challenges related to safety and oversight with relation to HIT vendors, customers, and their patients. It states that the vendor and user have duties to protect patient safety, and they have a responsibility to have mechanisms of identifying and correcting errors in product design. The paper also addresses concerns and weighs in on government regulation [4].
Regarding contracts, the white paper states: "Contracts should not contain language that prevents system users, including clinicians and others, from using their best judgment about what actions are necessary to protect patient safety." It goes on to state "Task Force recommends that AMIA join with other stakeholders to revisit the role of governmental and other formal regulation and governance of institutions that manufacture and use health information systemsd including, but not limited to, electronic health records, personal health records, computerized provider order entry systems, electronic medication administration record systems, and laboratory systems." [6]
The issue of EHR safety appears to be increasing in importance, and as the systems become more widely adopted, safety policies seem to be evolving.
Other Key Individuals: Senator Chuck Grassley has been pursuing the issue of safety in health IT. http://grassley.senate.gov/ Scot Silverstein MD has been maintaining a website since 1999: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=home
Reporting Websites: EHRevent.org has recently been launched in the fall of 2010, in addition to previous efforts including www.ehrsafety.org.
[1] The Office of the National Coordinator for HIT. Being a Meaningful User of Electronic Health Record. http://healthit.hhs.gov/portal/server.pt?CommunityID=2998&spaceID=42&parentname=&control=SetCommunity&parentid=&in_hi_userid=12059&PageID=0&space=CommunityPage [2] Lyman JA, Cohn WF, Bloomrosen M, Detmer DE. Clinical decision support: progress and opportunities. J Am Med Inform Assoc. 2010 Sep-Oct;17(5):487-92. [3] Carter JH. Electronic health records : a guide for clinicians and administrators. 2nd ed. Philadelphia: ACP Press; 2008. [4] Walker J et al. EHR Safety: The Way Forward to Safe and Effective Systems. JAMIA 2008. DOI 10.1197/jamia.M2618 http://www.geisinger.org/info/innov_conf/medicalHomeConf/references/2008%20EHR%20safety.pdf [5] Goodman KW et al. Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force. JAMIA 2010. http://jamia.bmj.com/site/icons/amiajnl8946.pdf
Submitted by Mark Johnson
EHR Safety
With the incentives towards implementing electronic health records (EHRs) across the nation with meaningful use [1], there has been a renewed interest in to safety. With continued unresolved issues of workflow and usability [2], safety issues remain a concern.
The EHR, clinical decision support (CDS), and CPOE is a software service and not considered a device, thus not regulated by the FDA for safety [3]. Dr. James Walker et. al. write in the viewpoint paper from 2008 provides a framework for the issue and recommends that the following steps should be followed: Use EHRs as tools for health care process improvement, design and implement safe EHRs, improve EHRs through safety testing and reporting, prevent and manage EHR-related incidents, communicate safety flaws and incidents, and develop and communicate EHR safety best practices [4].
An AMIA board position paper published in 2010 discusses challenges related to safety and oversight with relation to HIT vendors, customers, and their patients. It states that the vendor and user have duties to protect patient safety, and they have a responsibility to have mechanisms of identifying and correcting errors in product design. The paper also addresses concerns and weighs in on government regulation [4].
Regarding contracts, the white paper states: "Contracts should not contain language that prevents system users, including clinicians and others, from using their best judgment about what actions are necessary to protect patient safety." It goes on to state "Task Force recommends that AMIA join with other stakeholders to revisit the role of governmental and other formal regulation and governance of institutions that manufacture and use health information systemsdincluding, but not limited to, electronic health records, personal health records, computerized provider order entry systems, electronic medication administration record systems, and laboratory systems." [6]
The issue of EHR safety appears to be increasing in importance, and as the systems become more widely adopted, safety policies seem to be evolving.
Other Key Individuals: Senator Chuck Grassley has been pursuing the issue of safety in health IT. http://grassley.senate.gov/ Scot Silverstein MD has been maintaining a website since 1999: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=home
Reporting Websites: EHRevent.org has recently been launched in the fall of 2010, in addition to previous efforts including www.ehrsafety.org.
[1] The Office of the National Coordinator for HIT. Being a Meaningful User of Electronic Health Record. http://healthit.hhs.gov/portal/server.pt?CommunityID=2998&spaceID=42&parentname=&control=SetCommunity&parentid=&in_hi_userid=12059&PageID=0&space=CommunityPage [2] Lyman JA, Cohn WF, Bloomrosen M, Detmer DE. Clinical decision support: progress and opportunities. J Am Med Inform Assoc. 2010 Sep-Oct;17(5):487-92. [3] Carter JH. Electronic health records : a guide for clinicians and administrators. 2nd ed. Philadelphia: ACP Press; 2008. [4] Walker J et al. EHR Safety: The Way Forward to Safe and Effective Systems. JAMIA 2008. DOI 10.1197/jamia.M2618 http://www.geisinger.org/info/innov_conf/medicalHomeConf/references/2008%20EHR%20safety.pdf [5] Goodman KW et al. Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force. JAMIA 2010. http://jamia.bmj.com/site/icons/amiajnl8946.pdf
