WASHINGTONreport
BY JOSEPH GOEDERT
The Office of the
National Coordinator for Health
Information
Technology has
authorized four
organizations to
certify electronic
health records
under the Stage
2 meaningful use
program, known
as the 2014 Edition of certification. They are
the Certification
Commission for
Health Information Technology, Drummond
Group, ICSA Labs
and InfoGard
Laboratories.
Orion Register, a
newcomer that
ONC also named
as a certification
entity in August
pending NIST
testing, has
dropped out.
Four Named
Stage 2 EHR
Certifiers
ONC Releases
I.T. Safety Plan
for Public
Comment
The patient safety action plan is the re- sponse by the Office of the National Coordinator for Health Information Technology to the growing potential of health I. T. to be a contributor to medical errors. The ONC commissioned a study
by the Institute of Medicine about how to identify and mitigate those risks; the action plan is based on that study and its recommendations.
The action plan outlines goals, strategies and actions to get stakeholders to co-
ordinate efforts to improve health I. T. safety, some of which could have significant
impacts on the HIT regulatory environment. For example:
• One goal is to make it easier for clinicians to report patient safety events and
risks using EHR technology. To do so, ONC intends to propose using certification
criteria to ensure EHRs can facilitate reporting patient safety events in the Com-
mon Formats developed by the AHRQ.
The forms are a reporting tool that standardizes and promotes increased reporting of adverse events, near misses and unsafe conditions. The most recent version
of the Common Formats includes a “Device with Health IT” format that allows
collection of standardized information about I. T.-related adverse events as well as
events where health IT may be a contributing factor.
•The ONC plans to, within 12 months of the release of the safety plan, develop
a code of conduct for health I. T. vendors to enable them to “embrace their shared
responsibility for patient safety and promote reporting of patient safety events and
risks.” The ONC wants health I. T. developers to work with patient safety organizations, or similar entities, to report, aggregate, and analyze health I. T.-related safety
events. Developers would be required to provide safety information related to
their product for the purposes of improving patient safety. “Currently, the patient
safety work product (PSWP) protections do not extend to developers reporting
events to PSOs. However, HHS believes there may be ways developers can mitigate
risks of reporting. HHS will monitor this and would consider suggestions on how
to expand PSWP protections,” the proposed safety plan states.
• Another proposal is to incorporate health I. T. safety in post-market surveil-
lance of certified EHR technology through ONC-Authorized Certification Bod-
ies (ONC-ACBs). ONC will work with ONC-ACBs and the ONC-Approved Ac-
creditor to provide guidance
on: 1) developers keeping a re-
cord of complaints; 2) making
complaint records available to
the certification body upon re-
quest; 3) taking appropriate ac-
tion with respect to complaints;
and 4) documenting actions
taken. The ONC, the report
states, expects that ONC-ACBs
will conduct surveillance to
ensure that the capabilities of
certified EHR technology work
in operational settings to the
same extent as when they were
certified, and ONC-ACBs could
review and validate a sample of
the complaints EHR technol-
ogy developers receive.
Policy &
Regulation
www.healthdata
management.com/
policy-and-regulation
