Showing posts with label Office of the National Coordinator. Show all posts
Showing posts with label Office of the National Coordinator. Show all posts

Thursday, April 3, 2014

HHS Publishes FDASIA Health IT Report

HHS released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

The report was developed by the U.S. Food and Drug Administration (FDA) in consultation with two other federal agencies that oversee health IT: HHS’ Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC). The FDA seeks public comment on the draft document. Comments can be submitted HERE on regulations.gov

The agencies are also holding a three day public workshop on May 13, 14, and 15 2014 at the National Institute of Standards and Technology to discuss the framework and its components. I would encourage anyone interested in health IT including consumers, providers, and healthcare organizations to register for the workshop HERE. It will be available via webcast or in person, but registration is required.

“The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” said HHS Secretary Kathleen Sebelius. “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety.”

"ONC welcomes comment on the draft report and stands ready to collaborate with stakeholders to ensure that health IT is designed and used with both innovation and patient safety in mind," National Coordinator for Health IT Karen DeSalvo said.

“This proposed strategy will facilitate innovation, protect patients and support FDA’s focused oversight on higher risk technology, similar to medical devices that are currently regulated,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “FDA looks forward to additional stakeholder feedback on the proposed framework in this draft report.”

Included in the framework is a proposal for ONC to create a public-private Health IT Safety Center in collaboration with the FDA, the FCC, HHS’ Agency for Healthcare Research and Quality (AHRQ) and other stakeholders. The Health IT Safety Center would work on best practices and provide a forum for the exchange of ideas and information focused on patient safety.


In the FDASIA legislation Congress required the FDA, ONC, and FCC to develop “a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.” This report fulfills that requirement. The report proposes a risk-based regulatory framework for health IT which focuses on the functionality of health IT products not the platform themselves. The report suggests there will be few changes to most regulatory policies, and although they touch on mobile health applications, they don’t provide any new details on how the FDA will regulate mobile health apps deemed to be regulated medical devices or accessories to medical devices.

The proposed strategy identifies three categories of health IT:
  • Administrative health IT functions (requiring no additional oversight),
  • Health management health IT functions (no FDA oversight), and
  • Medical device health IT functions (FDA oversight continues).

Medical device health IT functionality is where FDA will focus its oversight. Oversight of health management health IT will be through the enforcement of standards and through testing and certification, primarily overseen by the ONC. Conformance to standards will be used to meet some regulatory requirements. This is the area that will have the broadest impact on the health information exchange market. The report concludes that product testing, certification and accreditation can provide assurance that certain products, services, systems, or organizations meet specified standards or fulfill certain requirements. They recommend that these tools should be used and applied in a risk- based manner to distinguish high quality products, developers, vendors and organizations from those that fail to meet a specified level of quality, safety, or performance. They also recommend that non- governmental, independent programs to perform conformity assessments should be developed to fill current gaps.

As I mentioned, they have also proposed the creation of a Health IT Safety Center (funding has already been included in the President's budget request to Congress). This public-private entity would be created by ONC, in collaboration with FDA, FCC, and the Agency for Healthcare Research and Quality (AHRQ), with involvement of other Federal agencies, and other health IT stakeholders. They are seeking comment on how to best implement the creation of this entity. Instead of regulation, they will rely mainly on stakeholders reaching a consensus and voluntarily abiding by agreed-on industry standards.

Health management HIT functions (clinical software), includes but is not limited to: health information and data management, data capture and encounter documentation, electronic access to clinical results, most clinical decision support, medication management (eMAR), electronic communication and coordination among providers and patients, provider order entry, knowledge (clinical evidence) management, and patient identification and matching. “The agencies believe the potential safety risks posed by health management IT functionality are generally low compared to the potential benefits and must be addressed by looking at the entire health IT ecosystem rather than single, targeted solutions,” the report says. The report identifies the following four key priority areas for health management health IT functionality and then outlines some potential next steps that could be taken to help more fully realize the benefits of health IT:

  1. Promote the Use of Quality Management Principles;
  2. Identify, Develop, and Adopt Standards and Best Practices; They identified the following specific focus areas for standards and best practices implementation:
    • Health IT design and development, including usability;
    • Local implementation, customization and maintenance of health IT;
    • Interoperability;
    • Quality management, including quality systems;
    • Risk management.
  3. Leverage Conformity Assessment Tools; and
  4. Create an Environment of Learning and Continual Improvement.


The report recommends that entities be identified to develop tests to validate interoperability, test product conformance with standards, and transparently share results of product performance to promote broader adoption of interoperable solutions. It will be very important to engage with the agencies during the comment period and the public meetings that will be scheduled over the next 90 days. It is also very likely that there will be hearings on Capitol Hill to review the report and it is possible that additional legislative action could be taken

There was a teleconference held on Thursday April 3, 2014 at 4:00 pm by the FDA, ONC and FCC to discuss the report and respond to questions. The panel was moderated by Stephanie Joseph, MPH, Health Programs Coordinator, Office of Health and Constituent Affairs, Office of External Affairs, FDA

Panelists included:
  • Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health, FDA
  • Jodi Daniel, Director of the Office of Policy Planning,  ONC
  • Matthew Quinn, Director, Healthcare Initiatives, FCC
Audio of the panel is below

Tuesday, January 28, 2014

Health IT State of the Union

I appeared on the Fed Tech Talk radio program on Federal News Radio which aired on WFED 1500 AM in Washington, DC on January 28, 2014. It was a fun discussion with host John Gilroy (check out his blog here) where we discussed the Office of the National Coordinator for Health Information Technology (ONC) Annual Meeting, the historic signing of an MOU between the United States and Great Britain on sharing health IT tools, health information exchange, EHR adoption, the Direct Project, mobile health, and the current state of health IT in the nation.

I gave some background on my involvement in health information technology and an overview of the landscape in health IT and how we are building out an infrastructure to improve our healthcare system. This was a lot of fun, and hopefully helped get the word out that the state of health IT in this country is strong, and we are looking at the best year ever ahead. The bottom line is that it is time to drag the US healthcare system (albeit kicking and screaming) into the 21st century of technology.





Thursday, December 19, 2013

Dr. Karen DeSalvo Named National Coordinator for Health IT

Dr. Farzad Mostashari tipped me off to the interesting video below:

"
Dr. Karen DeSalvo at the 2012 ONC Annual Meeting

Below is a note from Secretary Sebelius to HHS staff, followed by a note from Dr. Reider to ONC staff.


Colleagues,

I would like to announce that Dr. Karen DeSalvo, who currently serves as the City of New Orleans Health Commissioner and Senior Health Policy Advisor to Mayor Mitch Landrieu, will be the next National Coordinator for Health Information Technology here at the Department.

During her tenure, Dr. DeSalvo has been at the forefront of efforts to modernize the New Orleans health care system. Following Hurricane Katrina, for example, she led projects to increase access to care by augmenting the city’s neighborhood-based medical homes for low income, uninsured and other vulnerable populations in the New Orleans area.

Throughout her career, Dr. DeSalvo has advocated increasing the use of health information technology (HIT) to improve access to care, the quality of care, and overall population health outcomes –including efforts post-Katrina to redesign of the health system with HIT as a foundational element. She served as President of the Louisiana Health Care Quality Forum, the Louisiana lead for their health information exchange and regional extension center grants. She has also served as a member of the Steering Committee for the Crescent City Beacon Community grant.

As the New Orleans Health Commissioner she has made the increased utilization of HIT a cornerstone of the city’s primary care efforts and a key part of the city’s policy development, public health initiatives and emergency preparedness. Further, she has led the planning and construction of the city’s newest public hospital, which will have a fully-integrated HIT network. Her work as commissioner has led to positive changes to the way healthcare providers deliver care to their patients, improved accessibility and outcomes for patients, and improved the health of all New Orleanians. Dr. DeSalvo is a graduate of Suffolk University, Tulane Schools of Medicine and Public Health, Harvard School of Public Health.

Dr. DeSalvo’s hands-on experience with health delivery system reform and HIT and its potential to improve health care and public health will be invaluable assets to the Office of the National Coordinator and the Department. I would also like to take this opportunity to thank Dr. Jacob Reider, the Acting National Coordinator for his leadership of ONC during this time of transition. I am pleased she is joining our committed team, and ask you to join me in welcoming her to HHS when she starts on Monday, January 13th.

Sincerely,


Kathleen Sebelius


Tuesday, February 12, 2013

Inaugural ONC Google Plus Hangout

On Tuesday February 12, 2013 the HHS Office of the National Coordinator hosted it's first Google + Hangout. The participants were:

  • Doug Fridsma, M.D., Ph.D. - Chief Scientist at ONC
  • Arien Malec - VP Strategy and Product Marketing at RelayHealth, Former Coordinator for the Direct Project
  • Deven McGraw - Director of the Health Privacy Project at CDT
  • John Moehrke - Principal Engineer: Interoperability and Security at GE
  • Vince Kuraitis - Principal, Better Health Technologies, LLC
  • Brian Ahier - Health IT Evangelist
  • John Travis - Senior Director and Solution Strategist, Regulatory Compliance at Cerner
  • Alice Leiter - Policy Counsel at Center for Democracy & Technology

It was a very interesting conversation and I look forward to future ONC Hangouts. This was a great example of government as a platform and I expect there will be some great uses of this tool for engaging the health IT community.

Friday, September 7, 2012

Now Is Not the Time for Regulations on NwHIN Governance

In the hyper partisan atmosphere of a national election there is a great debate on the proper role of government and the utilization of regulations versus free market approaches. I have always believed the meme promulgated by Tim O'Reilly and others that government functions best as a platform for innovation in the role of convener and collaborator. This is one of the bedrock principles of government 2.0. I'd encourage you to read "Open Government"  if this is a topic you are interested in. There is a great deal of overlap between open government and health information technology, especially as we look to digitize health records and provide interoperability while engaging patients in their care.

I have long thought that one of the best agencies within the federal government exemplifying government 2.0 and open government principles is the Office of the National Coordinator (ONC) for Health IT (see my post here for previous examples). Dr. Farzad Mostashari, the current National Coordinator, has continued and improved on this tradition. An example of that is the flexible and thoughtful approach taken to governance and health information exchange.

When the ONC asked for comments on their proposed governance for the nationwide health information network there was a chorus of responses that resoundingly asked to put the brakes on and take a more measured approach. One of the primary issues the governance attempted was to help create a framework for a strong trust fabric, which is necessary for health data exchange to scale. The rules were meant to provide the policies necessary to create and maintain this network of networks that would result in robust nationwide exchange. The HITECH has specific language which requires the ONC to establish a governance mechanism for the nationwide health information network.

NwHIN RFI had 66 questions regarding areas of proposed governance focusing on 5 areas:
  • The establishment of a set of conditions for trusted exchange (CTEs)
  • Validation process for entities to demonstrate conformance to the CTEs (and subsequently become an Network Validated Entity (NVE))
  • Processes to update and retire CTEs
  • Establishment of a process to classify the readiness of technical standards and implementation specifications to support interoperability related CTEs
  • Approaches for monitoring and transparent oversight
There was very strong push back from the exchange community and many industry stakeholders were concerned that the process was moving much too quickly and a lighter approach should be considered. I joined with many groups in the process of responding to the RFI and shared many of these concerns. The NwHIN Power Team of the HIT Standards Committee also had some similar concerns. Across the board the comments indicated that the community thought that regulation at this time would actually slow the development of trusted exchange if it is implemented prematurely. And with the emerging governance activities of Healtheway for the eHealth Exchange (formerly NwHIN Exchange) and the work being done by DirectTrust.org to develop a strong trust fabric for the Direct community, a regulatory framework could actually stifle the process.

Well, the ONC was listening and have responded with a new approach. Dr. Mostashari and Jodi G. Daniel, JD, MPH who serves as Director of the Office of Policy and Planning at ONC gave an update to the HIT Policy Committee  on September 6, 2012 to outline their new approach to governance. Dr. Mostashari also posted a blog on the topic. It is important to note that the statutory requirement is to establish a governance mechanism, and that may not necessarily require rulemaking, but could leverage existing mechanisms. In any event there is no current legislative timeline requirement, so I appreciate that ONC is taking their time and being careful and flexible in their approach. I would encourage everyone to watch the webinar below:


Thursday, March 22, 2012

Consumer Innovation Challenge


I am privileged to work with the ONC and six different states that are responding to the Consumer Innovation Challenge. The goal of the Challenge is to rapidly create a project that will provide patients with access to their health information within six months. These six projects will use about $200,000.00 - $300,000.00 each to rapidly create innovations with diverse areas of focus. It was an impressive group of innovators assembled for this challenge and these projects will help to improve healthcare and be a model for similar efforts around the country. From reducing breast cancer disparities to reaching out to homeless and underserved patients this is an opportunity for some innovation incubators to make a real difference.

Illinois – Chicago Mammography Image Exchange (CMIX)


The Metropolitan Chicago Healthcare Council is helping spearhead an effort to reduce a huge problem of racial disparities in breast cancer treatment in the Chicago metro area. This project will provide a cloud-based service to provide patients with easy access to mammography images via their Microsoft Health Vault PHR, while providing clinicians with the ability to search and retrieve mammography images from any web browser-based device. By making prior mammography images available at the point of care, physicians will be able to discern subtle tissue changes that would otherwise be undetected. This will allow for an earlier cancer diagnosis, when treatment is more likely to produce better patient outcomes and to do so at a lower cost. It is our expectation that CMIX will allow Chicago to reduce the current disparity in mortality rates.

As mammograms are created, a copy of the DICOM file will be sent via a VPN HL7 interface to the cloud-based Vendor Neutral Archive (VNA). Once stored in the VNA, a copy of the DICOM file will be sent via secure Internet, using the DIRECT protocol, for storage in the patient’s Microsoft Health Vault PHR. It can also be sent into the Chicago HIE. Patients will interact with their images and reports via their PHR. The data will be stored in Microsoft’s Health Vault container, which can support more than 40 different PHR front ends. This will allow patients to change health insurance (and PHRs) without losing access to their data.

The Chicago Breast Cancer Quality Consortium, a collaborative of Chicago-area health care providers, carried out research that showed that African-American women in Chicago with the disease are much more likely to die of it than their white counterparts. In the early 1980s, although the breast cancer mortality rates for white women in Chicago were higher than that of black women, the disparity between the two was comparatively low, only about 9%. Then, rates for white women went down dramatically but the rates for black women did not go down at all; in fact, they increased. Disparities began to widen dramatically in the early 90s and continued to widen through 2007. From 2005 through 2007, the death rate from breast cancer for black women was an average of 62% higher than that for white women. The trends have continued and this project seeks to reverse these terrible statistics.

Indiana – Consumer Access to Immunization Records


This project will create a customer portal that would provide individuals, parents or guardians access to the Children and Hoosier’s Immunization Registry Program (CHIRP). CHIRP is currently designed for and used by medical professionals in the state of Indiana. The application stores specific patient level vaccine history on about 6 million residents. The portal would act as a gateway to CHIRP while preventing non medical professionals from having direct access to the registry. This portal will provide screen view and download capability delivery options via Blue Button. Other features will include a CCD export option and audit trail tracking history.

Having access to current immunization information is important. Without access to a child's immunization information, it can be difficult to know which vaccine a child needs at any particular time. Currently parents are asking healthcare providers, schools and others to print immunization data for their children, sometimes many times a year. Providing a web portal for parents to manage this information makes sense and I expect pretty rapid adoption for this project.

Montana – State-Wide HIE as the Source of Aggregated Data for a Consumer Health Management Platform


HealthShare Montana will partner with PHR vendor Dossia to use aggregated CCD data from the HIE warehouse as the source for the Dossia Health Management System using Direct exchange standards. This system integrates aggregated personal health information with healthcare tools adding a layer of engagement, comprised of game and social dynamics, incentives and messaging in order to foster sustained user engagement, behaviour change and value. Providing patients access to and control of their own health information is without questions a very good thing. The lessons learned in Montana are going to be very valuable for scaling these types of projects nationally.

Maryland – CRISP to Microsoft HealthVault Interoperability


The Chesapeake Regional Information System for Our Patients (CRISP) is a not-for-profit membership corporation which is designated Maryland’s statewide health information exchange as well as the Regional Extension Center for Health IT (REC). This project will allow Maryland’s patients to be able to receive, store and share health information about them from the statewide health information exchange using Microsoft HealthVault. The first phase of the project is to use Direct to send health data from CRISP to HealthVault. The second phase of the project will be to allow patients to share the health information from their HealthVault account with providers across Maryland via CRISP. This will require onboarding HealthVault as a node on the statewide HIE. HealthVault’s functionality would need to enable patients to select CRISP as an outbound data feed and to have some level of granular control over which pieces of data within HealthVault they wish to make available.

Nebraska – “Big Red Button” Exchange to Consumers


The Nebraska Health Information Initiative (NeHII) and SimplyWell, a company which provides PHRs and employer wellness programs, are partnering to enable a XDS registry query and passage of the SAML token from SimplyWell to NeHII that will allow for the exchange of the CCD from NeHII to SimplyWell. Patients participating in SimplyWell’s PHR through their self insured employer will be able to request electronic access to their clinical health records from participating hospitals, labs, and clinics via a CCD document from NeHII. NeHII will use the ordering gateway and HIE clinical results delivery functionality to provide administrative value to SimplyWell, which routinely uses third party reference laboratories to process wellness checks for members and receives results via proprietary interfaces. NeHII will eventually offer PHRs to a broader set of consumers seeking their health data. It will also provide the ability to share their health information among providers.

Georgia – Chatham Connect with Direct


ChathamHealthLink (CHL) is an HIO in Chatham County, Georgia. CHL was developed to serve the needs of the significant population of uninsured and indigent patients who seek care in five clinics and two hospital systems. Chatham Connect with Direct, is designed to leverage the Georgia HIE Strategic Lab Program and the Georgia HIE Direct Project to build single, central patients records containing laboratory results from diverse sources which are then accessible to the patient using secure Direct addresses.

Chatham Connect with Direct will focus on using Direct addresses as both an identification/authentication solution for patient access and a key identifier in matching incoming laboratory data from the lab hub to patient records in CHL. Chatham Connect with Direct will also partner with state agencies to undertake the analysis and study necessary to integrate the Georgia HIE Strategic Lab Program with the Direct project on behalf of patients. One goal of this project is to design a model program that can be implemented by any of the existing HIEs in Georgia and the GaHIE being developed for the state. I am very excited for this project and look forward to seeing the real world impact this will have on this underserved patient population.

New incentives + Information liberation = Rocket fuel for innovation


This challenge is exciting on many fronts. Using challenges has been an effective method of spurring innovations with Todd Park's rocket fuel formula. Being a part of government being used as a platform for applying technology to solve healthcare problems and innovations rapidly developed is great fun. A number of the projects are using Direct Project standards to engage patients, so I am particularly enthusiastic to see these develop. But the best part of this challenge for me, after having met and worked with each of the participants, is the people that are leading these efforts. I am inspired by this fine group of innovators and their passion for making a difference.

Thursday, February 23, 2012

Proposed Rules for Stage 2 Meaningful Use

Stage 2 Meaningful Use Has Arrived finally

We have known that the proposed rules for stage 2 meaningful use under the EHR Incentive Program were on their way. I had hoped that they would be released on Febraury 17, 2012, which was the third anniversary of the passage of the HITECH Act. Sadly, we did not get to read them prior to HIMSS. Nor did we get to read them prior to many of the learning sessions on stage 2 meaningful use scheduled at HIMSS the first two days. But, finally they are here (and sadly not even in time for Farzad Mostashari's keynote address as some had predicted). This will certainly be a major topic of conversation after the HIMSS conference (along with clouds, mobile and collaboration). There are two rules pertaining to stage 2 meaningful use: Medicare and Medicaid Electronic Health Record Incentive Program--Stage 2; and the New and Revised Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology which is not yet published. I will be posting some deeper analysis coming weeks on each of the rules once I have had some time to actually read them in more detail and the S&C rule is published.

Stage 2 Meaningful Use

First, let's look at the NPRM for Stage 2 meaningful use. The final rule for the Medicare and Medicaid EHR Incentive Programs, which was published in the Federal Register on July 28, 2010, specifies that CMS will expand on the criteria for meaningful use established for Stage 1 to advance the use of certified EHR technology by eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs). This proposed rule would establish the requirements for Stage 2. As stated in the July 28 final rule, "Our goals for the Stage 2 meaningful use criteria, consistent with other provisions of Medicare and Medicaid law, expand upon the Stage 1 criteria to encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible, such as the electronic transmission of orders entered using computerized provider order entry (CPOE) and the electronic transmission of diagnostic test results."

One of the significant changes is in the timing for implementation of stage 2 meaningful use. This change was expected and will become official under the final rule expected this summer. Under the current requirements, eligible doctors and hospitals that began participating in the Medicare EHR Incentive Programs in 2011 would have had to meet new standards for the program in 2013. If they did not participate in the program until 2012, they could wait to meet these new standards until 2014 and still be eligible for the same incentive payment. To encourage faster adoption the rule allows doctors and hospitals to adopt health IT in 2011, without meeting the new standards until 2014. The proposed rule would move all menu set items to core measures, and many of the percentages are increased, and some new menu objectives added.

Other significant aspects of the rule are around improving care transitions and patient engagement, including health information exchange and interoperability of EHRs. The requirement that patients have electronic access to their information is proposed to become that patients have used the capability to access and download their information and have communication preferences stated, as well as a requirement that 10% patients get reminders for preventive, follow-up care. Patients will have the right to view and download (on demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patients should be able to filter or organize information by date, encounter, etc. Patient engagement will be critical to allow patients to share accountability for their care and obtain better health. There is also a new requirement for Eligible Hospitals (EH)s that 80% of patients offered the ability to view and download via a web-based portal, within 36 hours of discharge, relevant information contained in the record about EH inpatient encounters. It will be required that data are available in human-readable and structured forms. (A web portal as defined as online access to health information. Therefore all web portals defined as such are subject to HIPPA rules and regulations.)

The requirement that a summary of care record must be transmitted between providers at transitions in care is ramped up and using paper is no longer an option. Secure messaging is a requirement, and there is a standards and certification requirement that Direct Project protocols are enabled in the EHR. The health information exchange requirement goes from merely performing one test to the ability to connect to at least three external providers in the primary referral network (but outside delivery system that uses the same EHR) or establish an ongoing bidirectional connection to at least one health information exchange organization. Sharing health data among providers is necessary to be accountable for care and the health of a patient population. The requirements for quality reporting in meaningful use are increasing at the same time that new reimbursement models are tied to performance. Quality reporting will eventually need to be in real time so that gaps in care can be avoided, rather than simply reported.

Medicare and Medicaid Programs; Electronic Health Record Incentive Program-- Stage 2

Stage 2 Standards and Certification Criteria

In order to successfully meet the requirements for meaningful use, hospitals and EPs must meet Stage 2 objectives and measures using “Certified EHR Technology.” Certified EHR Technology is defined as an EHR (either a Complete EHR or combination of EHR Modules) that has been certified against all applicable certification criteria adopted by ONC for a given payment year. With the delay of Stage 2 Meaningful Use implementation, this allows additional time for EHR vendors to design, develop and release new functionality, which was also cited as one of the reasons behind the recommended delay.

Below is the NPRM on Standards, Implementation Specifications, and Certification Criteria for stage 2 meaningful use. The final rule that established the initial set of standards, implementation specifications, and certification criteria was published in the Federal Register on July 28, 2010. The initial set represented the first round of an incremental approach to adopting future sets of standards, implementation specifications, and certification criteria to enhance electronic health record (EHR) interoperability, functionality, and utility. Under the authority provided by section 3004 of the Public Health Service Act (PHSA), this notice of proposed rulemaking would propose that the Secretary adopt revisions to the initial set as well as new standards, implementation specifications and certification criteria. The proposed new and revised standards, implementation specifications, and certification criteria would establish the technical capabilities that certified EHR technology would need to include to support meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs.

The ONC has created a new certification called Certified EHR Technology that will replace current certification. This will begin at the implementation of Stage 2 Meaningful Use in 2014 (they are creatively calling this the 2014 edition). There will be two types of certification: a Base EHR and a Core EHR. Some of the baseline capabilities of a Base EHR are history and problem list, clinical decision support, CPOE, capture quality data and data query. privacy and security, and health information exchange.

One of the requirements is the View and Download for patients certification criterion which combines several previous certification requirements:
Enable a user to provide patients with the ability to view and download their longitudinal health information online, and to electronically transmit this information directly to patients. Also, enable users to track transmission events and when information is viewed and downloaded. Information must include, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, procedures, clinical summaries and discharge instructions, and be provided in:
(i) Human readable format;
(ii) The standard (and applicable implementation specifications) specified in the new single standard and implementation guide and with data elements using applicable standards;
(iii) Track the number of patient online accesses (view and download) or transmission events.

Electronic access via online access is intended to include an online portal and/or PHR directly tied to the EHR or a third party patient portal and or PHR that is connected to the EHR. The third party solution (PHR and/or patient portal) may be directly connected to that EHR or through an HIE connection that offers electronic patient access. Similarly, the intention here is that the EHR needs to demonstrate one of these options for certification (not all of them). There is also the criteria that secure messaging is enabled that would allow a user to electronically send a secure message to a patient; and also receive a secure message from a patient. As mentioned previously Direct Project protocols must be enabled, which shows a continued emphasis on promoting these standards.

Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technolog...


Thursday, January 12, 2012

Further Analysis of Data on Meaningful Use Attestation

Comments on my previous post about the data on meaningful use attestation as well as emails, and conversations on social media have led me to want to show the specific data for inpatient and ambulatory attestations. I also include the excellent presentation to the HIT Policy Committee by Robert Tagalicod, Robert Anthony, and Jessica Kahn from CMS on their analysis of the data (including the element not available on data.gov - the money paid out in incentive payments). So first let's look at the Eligible Hospital attestations. Here are the top ten vendors on the inpatient side so far:


It is interesting that Cerner and Meditech are really doing great, while Epic is lagging so far on hospital attestations on the inpatient side, and it's important to note that HCA is using modular systems that incorporate much of Meditech's product. Here are the top ten vendors by attestation for EPs:


It appears that EPIC is by far the vendor with the greatest number of EP attestations (although I suspect that these are employed providers of large health systems). As the Medicaid programs are launched in all the states and those EPs attesting under AIU began to come in I suspect we will see greater numbers for vendors who are in smaller practices.

Tuesday, January 10, 2012

Data on Meaningful Use Attestation

Some very interesting data on meaningful use attestations thus far. While the reports already posted by CMS provide good information (such as the map below with a state by state breakdown), the data released on Data.gov enables systematic analysis of the distribution of certified EHR vendors and products among those providers that have attested to meaningful use within the CMS EHR Incentive Programs. The data set can be analyzed by vendor, state, provider type, provider specialty, and practice setting. One data point that would make this even sexier is the dollar amount paid for each attestation, but hopefully that can be included in future releases. I'll be doing some deeper analysis of this data, but some initial interesting facts are noticeable about state and vendor figures.



Here are the top 25 states in number of attestations for meaningful use as of November 2011:

Attestations State/Territory
1761 Texas
1653 Ohio
1533 Illinois
1450 Pennsylvania
1387 Florida
1287 California
1272 New York
963 Minnesota
931 Massachusetts
812 Wisconsin
752 New Jersey
638 New Hampshire
606 Oregon
588 Virginia
525 North Carolina
520 Michigan
502 Georgia
457 Washington
384 Tennessee
370 Arizona
351 Missouri
302 Indiana
288 Colorado
280 Oklahoma

Here are the top 25 vendors by attestation:

Attestations Vendor 
6330 Epic Systems Corporation
1847 eClinicalWorks LLC
1502 Allscripts
1158 athenahealth, Inc
999 Community Computer Service, Inc.
921 GE Healthcare
899 NextGen Healthcare
770 e-MDs, Inc.
712 Greenway Medical Technologies, Inc.
567 Cerner Corporation
565 Sage
397 BioMedix Vascular Solutions
264 HCA Information & Technology Services, Inc.
256 MEDITECH
252 AmazingCharts.com, Inc.
239 Eyefinity/OfficeMate
210 meridianEMR, Inc.
206 McKesson
199 Sammy Systems
179 SOAPware, Inc.
174 Health IT Services Group
164 ChartLogic, Inc.
147 MedInformatix, Inc
144 Compulink



Wednesday, January 26, 2011

Information Exchange Workgroup Provider Directory Task Force 1-24-11

The Information Exchange Workgroup Provider Directory Task Force met on January 24, 2011 and continued their discussion on Individual Level Provider Directories. The webinar is below:

Monday, January 24, 2011

Stage 2 Meaningful Use Request for Comments

The Health Information Technology Policy Committee, which advises the Department of Health and Human Services, is seeking comments through Feb. 25 on an initial set of proposed requirements for stage 2 meaningful use of electronic health records. The committee plans to hold public hearings this spring, and to issue final recommendations to HHS this summer for consideration in rulemaking. We should all plan to submit comments on the proposed stage 2 requirements currently under consideration. This will give ample opportunity for broad stakeholder input into the process before the proposed rule and final rule are published. Comments can be submitted here on regulations.gov. Below is information on the request for comment from the Meaningful Use Workgroup Regarding Meaningful Use Stage 2 [PDF]


HIT Policy Committee:
Meaningful Use Workgroup Request for Comments Regarding Meaningful Use Stage 2

I. Background

The Health Information Technology Policy Committee (HITPC) is a federal advisory committee that advises the U.S. Department of Health and Human Services (HHS) on federal HIT policy issues, including how to define the ―meaningful use‖ (MU) of electronic health records (EHRs) for the purposes of the Medicare and Medicaid EHR incentive programs. The HITECH portion of the American Recovery and Reinvestment Act (ARRA) of 2009 specifically mandated that incentives should be given to Medicare and Medicaid providers not for EHR adoption but for ―meaningful use‖ of EHRs. In July of 2010, HHS released that program’s final rule, thus defining stage 1 MU and strongly signaling that the bar for what constitutes MU would be raised in subsequent stages in order to improve advanced care processes and health outcomes.

The HITPC held six public hearings in 2010 including testimony from several dozen stakeholders and received additional dozens of public comments via its blog. All of this input helped to inform its many hours of public deliberations regarding the future vision of MU (e.g., stage 3) as well as the interim stepping stone of stage 2 MU that will set expectations for 2013 and 2014.

The HITPC has developed a preliminary set of recommendations specifically designed to solicit additional public feedback. The goal of sending out this request for comment (RFC) early is threefold.

  1. Provide some signal to the industry of potential new EHR functionalities that the HITPC may recommend to help the industry get a head start on developing new functionalities.
  2. Extend the public discussion of future stage MU definitions through a more formal public comment process well in advance of its formal final stage 2 recommendations to be issued in the summer of 2011.
  3. Request input on specific questions.

Following analysis of the comments received through the approximately 45-day public comment period, the HITPC intends to revisit these recommendations in its public meetings in the spring of 2011. At that time, the HITPC will be able to review public comments in the context of the early feedback from providers on experience with stage 1 MU. That input will come through many vehicles: the Medicare program, the Medicaid program (both federal and state constituencies), the HIT regional extension program, and other sources. Note, this RFC solely represents the preliminary thinking of the HITPC and its Meaningful Use Workgroup.

Structure and Relevant Concurrent HITPC Activities

The HITPC has created a matrix of objectives and measures that it is considering for its recommendations to HHS. These objectives are organized into four of the five health outcome priorities that formed the stage 1 MU organizing structure. The HITPC approached its task of developing proposed stage 2 objectives by first developing a longer-term vision for MU and then determining what an appropriate stage 2 stepping stone is to get there. For this reason, the matrix includes possible stage 3 objectives, but they are only included in the matrix in order to provide context for the Stage 2 recommendations. Therefore, for the purpose of this Request for Comments, the HITPC is primarily interested in comments on the proposed Stage 2 objectives at this time.

The HITPC has a concurrent activity that is developing Stage 2 and 3 recommendations for the fifth health outcome priority — ensure adequate privacy and security protections for personal health information. The HITPC and its Privacy & Security Tiger Team will subsequently release recommendations for this domain.

In addition, the HITPC has a Quality Measures (QM) Workgroup that is concurrently developing a framework for the evolution of clinical quality measures to be electronically reported as part of Stages 2 and 3 MU. The HITPC recently collected public input through a request for comment on a set of proposed measure concepts, and it will provide more guidance on its measure development priorities in the near future following synthesis and analysis of those public comments. Other recommendations about information exchange are being developed by the HITPC’s Information Exchange Workgroup.

Proposed MU Objectives and Measures for Stages 2 and 3


Meaningful Use: Stage 1 Final Rule and Proposed Objectives for Stages 2 and 3
Improving Quality, Safety, Efficiency & Reducing Health Disparities
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
Comments
CPOE for medication orders (30%)
CPOE (by licensed professional) for at least 1 medication,  and 1 lab or radiology order for 60% of unique patients who have at least 1 such order (order does not have to be transmitted electronically)
CPOE (by licensed professional) for at least 1 medication, and 1 lab or radiology order on 80% of patients who have at least 1 such order (order does not have to be transmitted electronically)

Drug-drug/drug-allergy interaction checks 

Employ drug-drug interaction checking and drug allergy checking on appropriate evidence-based interactions
Employ drug-drug interaction checking, drug allergy checking, drug age checking (medications in the elderly), drug dose checking (e.g., pediatric dosing, chemotherapy dosing), drug lab checking, and drug condition checking (including pregnancy and lactation)  on appropriate evidence-based interactions
Reporting of drug interaction checks to be defined by  quality measures workgroup 


E-prescribing (eRx) (EP) (40%)
50% of orders (outpatient and hospital discharge) transmitted as eRx 
80% of orders (outpatient and hospital discharge) transmitted as eRx 
If receiving pharmacy cannot accept eRx, automatically generating electronic fax to pharmacy OK
Record demographics (50%)
80% of patients have demographics recorded and can use them to produce stratified quality reports
90% of patients have demographics recorded (including IOM categoriesi) and can use them to produce stratified quality reports

Report CQM electronically
Continue as per Quality Measures Workgroup and CMS
Continue as per Quality Measures Workgroup and CMS
The HIT Policy Committee’s Quality Measures Workgroup issued a request for comment in December; new measures will be considered after review of public comments

Maintain problem list (80%)
Continue Stage 1
80% problem lists are up-to-date
Expect to drive list to be up-to-date by making it part of patient visit summary and care plans

Maintain active med list (80%)
Continue Stage 1
80% medication lists are up-to-date
Expect to drive list to be up-to-date via medication reconciliation

Maintain active medication allergy list (80%)
Continue Stage 1
80% medication allergy lists are up-to-date
Expect to drive the list to be up-to-date by making it part of visit summary

Record vital signs (50%)
80% of unique patients have vital signs recorded
80% of unique patients have vital signs recorded


Record smoking status (50%)
80% of unique patients have smoking status recorded
90% of unique patients have smoking status recorded


Implement 1 CDS rule
Use CDS to improve performance on high-priority health conditions.
Establish CDS attributes for purposes of certification: 1. Authenticated (source cited); 2. Credible, evidence-based; 3. Patient-context sensitive; 4. Invokes relevant knowledge; 5. Timely; 6. Efficient workflow; 7. Integrated with EHR; 8. Presented to the appropriate party who can take action
Use CDS to improve performance on high-priority health conditions.
Establish CDS attributes for purposes of certification: 1. Authenticated (source cited); 2. Credible, evidence-based; 3. Patient-context sensitive; 4. Invokes relevant knowledge; 5. Timely; 6. Efficient workflow; 7. Integrated with EHR; 8. Presented to the appropriate party who can take action


Implement drug formulary checks* 
Move current measure to core
80% of medication orders are checked against relevant formularies
What is the availability of formularies for eligible professionals?

Record existence of advance directives (EH) (50%)*
Make core requirement. For EP and EH: 50% of patients >=65 years old have recorded in EHR the result of an advance directive discussion and the directive itself if it exists
For EP and EH: 90% of patients >=65 years old have recorded in EHR the result of an advance directive discussion and the directive itself if it exists
Potential issues include: state statutes; challenges in outpatient settings; age; privacy; specialists; needs to be accessible and certifiable; need to define a standard 
Incorporate lab results as structured data (40%)*
Move current measure to core, but only where results are available

90% of lab results electronically ordered by EHR are stored as structured data in the EHR and are reconciled with structured lab orders, where results and structured orders available

Generate patient lists for specific conditions*
Make core requirement. Generate patient lists for multiple patient-specific parameters
Patient lists are used to manage patients for high-priority health conditions


Send patient reminders (20%)*
Make core requirement. 
20% of active patients who prefer to receive reminders electronically receive preventive or follow-up reminders
How should ―active patient‖ be defined?

(NEW)
30% of visits have at least one electronic EP note
90% of visits have at least one electronic EP note
Can be scanned, narrative, structured, etc.
(NEW)
30% of EH patient days have at least one electronic note by a physician, NP, or PA
80% of EH patient days have at least one electronic note by a physician, NP, or PA
Can be scanned, narrative, structured, etc.
(NEW)
30% of EH medication orders automatically tracked via electronic medication administration recording
80% of EH inpatient medication orders are automatically tracked via electronic medication administration recording

Engage Patients and Families in Their Care
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
Comments
Provide electronic copy of health information, upon request (50%)
Continue Stage 1

90% of patients have timely access to copy of health information from electronic health record, upon request
Only applies to information already stored in the EHR

Provide electronic copy of discharge instructions (EH) at discharge (50%)
Electronic discharge instructions for hospitals (which are given as the patient is leaving the hospital) are offered to at least 80% of patients (patients may elect to receive only a printed copy of the instructions)

Electronic discharge instructions for hospitals (which are given as the patient is leaving the hospital) are offered to at least 90% of patients in the common primary languages (patients may elect to receive only a printed copy of the instructions)
Electronic discharge instructions should include a statement of the patient’s condition, discharge medications, activities and diet, follow-up appointments, pending tests that require follow up, referrals, scheduled tests  [we invite comments on the elements listed above]
EHR-enabled patient-specific educational resources (10%)
Continue Stage 1

20% offered patient-specific educational resources online in the common primary languages

(NEW for EH)
80% of patients offered the ability to view and download via a web-based portal, within 36 hours of discharge, relevant information contained in the record about EH inpatient encounters. Data are available in human-readable and structured forms (HITSC to define). 
80% of patients offered the ability to view and download via a web-based portal, within 36 hours of discharge, relevant information contained in the record about EH inpatient encounters. Data are available in human readable and structured forms (HITSC to define). 
Inpatient summaries include: hospitalization admit and discharge date and location; reason for hospitalization; providers; problem list; medication lists; medication allergies; procedures; immunizations; vital signs at discharge; diagnostic test results (when available); discharge instructions; care transitions summary and plan; discharge summary (when available); gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]
Provide clinical summaries for each office visit (EP) (50%)

Patients have the ability to view and download relevant information about a clinical encounter within 24 hours of the encounter. Follow-up tests that are linked to encounter orders but not ready during the encounter should be included in future summaries of that encounter, within 4 days of becoming available. Data are available in human-readable and structured forms (HITSC to define)

Patients have the ability to view and download relevant information about a clinical encounter within 24 hours of the encounter. Follow-up tests that are linked to encounter orders but not ready during the encounter should be included in future summaries of that encounter, within 4 days of becoming available. Data are available in human readable and structured forms (HITSC to define)

The following encounter data are included (where relevant): encounter date and location; reasons for encounter; provider; problem list;medication list; medication allergies; procedures; immunizations; vital signs; diagnostic test results; clinical instructions; orders: future appointment requests, referrals, scheduled tests; gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]

demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patient should be able to filter or organize information by date, encounter, etc. Data are available in human-readable and structured forms (HITSC to define). 

demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patient should be able to filter or organize information by date, encounter, etc. Data are available in human readable and structured forms (HITSC to define). 

locations; reasons for encounters; providers; problem list; medication list; medication allergies; procedures; immunizations; vital signs; diagnostic test results; clinical instructions; orders; longitudinal care plan;gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]

This objective sets the measures for ―Provide timely electronic access (EP)‖ and for ―Provide clinical summaries for each office visit (EP)‖

EPs: 20% of patients use a web-based portaliii to access their information (for an encounter or for the longitudinal record) at least once. Exclusions: patients without ability to access the Internet
EPs: 30% of patients use a web-based portaliii to access their information (for an encounter or for the longitudinal record) at least once. Exclusions: patients without ability to access the Internet

(NEW)
EPs: online secure patient messaging is in use

EPs: online secure patient messaging is in use


(NEW)
Patient preferences for communication medium recorded for 20% of patients
Patient preferences for communication medium recorded for 80% of patients
How should ―communication medium‖ be delineated?


Offer electronic self-management tools to patients with high priority health conditions
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3 objective


EHRs have capability to exchange data with
We are seeking comment on what
PHRs using standards-based health data exchange
steps will be needed in stage 2 to achieve this proposed stage 3objective


Patients offered capability to report experience of care measures online
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective


Offer capability to upload and incorporate patient-generated data (e.g., electronically collected patient survey data, biometric home monitoring data, patient suggestions of corrections to errors in the record) into EHRs and clinician workflow
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
Improve Care Coordination
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
Comments
Perform test of HIE

Connect to at least three external providers in ―primary referral network‖ (but outside delivery system that uses the same EHR) or establish an ongoing bidirectional connection to at least one health information exchange
Connect to at least 30% of external providers in ―primary referral network‖ or establish an ongoing bidirectional connection to at least one health information exchange
Successful HIE will require development and use of infrastructure like entity-level provider directories (ELPD)

Perform medication reconciliation (50%)*

Medication reconciliation conducted at 80% of care transitions by receiving provider (transitions from another setting of care, or from another provider of care, or the provider believes it is relevant)
Medication reconciliation conducted at 90% of care transitions by receiving provider


Provide summary of care record (50%)*

Move to Core

Summary care record provided electronically for 80% of transitions and referrals 

(NEW)
List of care team members (including PCP) available for 10% of patients in EHR

List of care team members (including the PCP) available for 50% of patients via electronic exchange


(NEW)
Record a longitudinal care plan for 20% of patients with high-priority health conditions

Longitudinal care plan available for electronic exchange for 50% of patients with high-priority health conditions

What elements should be included in a longitudinal care plan including: care team members; diagnoses; medications; allergies;goals of care; other elements?
Improve Population and Public Health
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
 Comments
Submit immunization data*

EH and EP: Mandatory test. Some immunizations are submitted on an ongoing basis to Immunization Information System (IIS), if accepted
and as required by law
EH and EP: Mandatory test. Immunizations are submitted to IIS, if accepted and as required by law. During well child/adult visits, providers review IIS records via their EHR.

Stage 2 implies at least some data is submitted to IIS. EH and EP may choose not, for example, to send data through IIS to different states in Stage 2. The goal is to eventually review IIS-generated recommendations
Submit reportable lab data*
EH: move Stage 1 to core 

EP: lab reporting menu. For EPs, ensure that reportable lab results and conditions are submitted to public health agencies either directly or through their performing labs (if accepted and as required by law).
Mandatory test.

EH: submit reportable lab results and reportable conditions if accepted and as required by law.
Include complete contact information (e.g., patient address, phone and municipality) in 30% (EH) of reports.

EP: ensure that reportable lab results and reportable conditions are submitted to public health agencies either directly or through performing labs (if accepted and as required by law)

Submit syndromic surveillance data*

Move to core.

Mandatory test; submit if accepted




Public Health Button for EH and EP: Mandatory test and submit if accepted. Submit notifiable conditions using a reportable public-health submission button. EHR can receive and present public health alerts or follow up requests.
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective


Patient-generated data submitted to public health agencies
We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
Ensure Adequate Privacy and Security Protections for Personal Health Information
Stage 1 Final Rule
Proposed Stage 2
Proposed Stage 3
Comments
Conduct security review analysis & correct deficiencies


Additional privacy and security objectives under
consideration via the HIT Policy Committee’s Privacy & Security Tiger Team
* menu option for Stage 1

Additional Specific Questions for Public Comment
The Health Information Technology Policy Committee welcomes public comment on all proposed objectives and their associated definitions. In addition, the Committee seeks specific input on the following additional questions.

  1. How can electronic progress notes be defined in order to have adequate specificity?
  2. For patient/family access to personal health information, what standards should exist regarding accessibility for people with disabilities (e.g., interoperability with assistive technologies to support those with hearing, visual, speech, or mobile impairments)?
  3. What strategies should be used to ensure that barriers to patient access – whether secondary to limited internet access, low health literacy and/or disability – are appropriately addressed?
  4. What are providers’ and hospitals’ experiences with incorporating patient-reported data (e.g., data self-entered into PHRs, electronically collected patient survey data, home monitoring of biometric data, patient suggestions of corrections to errors in the record) into EHRs?
  5. For future stages of meaningful use assessment, should CMS provide an alternative way to achieve meaningful use based on demonstration of high performance on clinical quality measures (e.g., can either satisfy utilization measures for recording allergies, conducting CPOE, drug-drug interaction checking, etc, or demonstrate low rates of adverse drug events)?
  6. Should Stage 2 allow for a group reporting option to allow group practices to demonstrate meaningful use at the group level for all EPs in that group?
  7. In stage 1, as an optional menu objective, the presence of an advance directive should be recorded for over 50% of patients 65 years of age or older. We propose making this objective required and to include the results of the advance-directive discussion, if available. We invite public comment on this proposal, or to offer suggestions for alternative criteria in this area.
  8. What are the reasonable elements that should make up a care plan, clinical summary, and discharge summary?
  9. What additional meaningful-use criteria could be applied to stimulate robust information exchange?
  10. There are some new objectives being considered for stage 3 where there is no precursor objective being proposed for stage 2 in the current matrix. We invite suggestions on appropriate stage 2 objectives that would be meaningful stepping-stone criteria for the new stage 3 objectives.

E. Evidence Base/Rationale for Proposed New Objectives

The HITPC identified proposed new objectives because of their potential impact on the five health outcome priorities to be achieved through the meaningful use of EHRs. Some of the relevant evidence to these proposed objectives is reflected below.

Patient and Family Engagement
In a randomized control trial assessing the efficacy of a home-based computer system in providing information and decision support as well as expert and other patient contacts to patients with HIV, findings were significant for improved quality of life indicators such as cognitive function, social support and participation in their health care, and also for decreased time spent during ambulatory visits, fewer phone calls to providers, and decreased number and length of hospitalizations.
Qualitative data analysis of provider impressions of a patient centered CDSS (Patient Assessment, Care and Education) designed to increase identification and treatment of chemotherapy related symptoms affirmed the increased awareness of underreported symptoms and additional benefits such as better communication with patients.
A retrospective cross-sectional study analyzing the adoption of and patient satisfaction with a PHR reported 25% of patients registered with PHR and reported over 90% satisfaction with the PHR, with greatest satisfaction with test results, medication refills, and secure messaging.
A CDSS electronic checklist specifically aimed to improve delivery of evidence based discharge instructions for patients with heart failure (HF) or acute myocardial infarction (AMI) was evaluated to be effective in increasing delivery of discharge instructions (from 37.2% pre-intervention to 93.0% post-intervention). In addition, prescription of ACEI or ARB in patients with HF and AMI improved to 96.7% from 80.7% and to 100% from 88.1%, respectively.
An interventional study assessing the effect of patient messaging reminding patients of screening, diagnostic and monitoring tests in accordance with evidence based guidelines found an increase in adherence to clinical recommendations by 12.5% (p < 0.001).
A randomized control trial of 246 patients who were newly diagnosed with breast cancer assessed the effect of a home-based computer system with information, decision-making and emotional support. The study found that patients in the intervention group were significantly more competent in seeking information, more comfortable participating in care, and more confident in their interactions with physicians at two months post intervention and had better social support and information competence at five months post intervention. Furthermore, the relative benefits in the intervention group were greater for patients in underserved populations.

Quality and Safety
A randomized control trial evaluating effect of CDSS alerting physicians to order venous thromboembolism (VTE) prophylaxis showed the intervention resulted in 41% decreased risk for VTE at 90 days.
Using CDS to alert physicians and pharmacists to 8 critical drug interactions resulted in 31% decrease in dispensed drugs known to have adverse interactions.
A prospective analysis of an antimicrobial surveillance system using evidence based guidelines in a children’s hospital showed successful identification of prescribing errors allowing for early intervention.
Analysis of a CDS system intervention aimed at improving asthma documentation and management in the emergency department found that asthma severity, asthma precipitants, ICU admission history and smoking status were recorded significantly more often with the CDSS. Additionally, 76% of patients received a discharge asthma plan compared with 16% before the intervention.
A prospective cohort study assessed efficacy of CDSS in identifying patients with acute lung injury (ALI) compared to physician diagnosis alone. This study is significant because early treatment of ALI is critical to overall prognosis. The CDSS had a sensitivity of 96.3% and specificity of 89.4% whereas physician diagnosis was 26.5% sensitive and 99.5% specific. Although the CDSS was less specific, physician diagnosis alone missed 239 cases while the CDSS missed 12.
A survey of ambulatory care providers assessed attitudes toward CPOE and e-prescribing systems and found that the majority reported improved quality of care and efficiency, prevention of medical errors, and increased patient satisfaction as advantages to the system. More than one third reported that in the last month they had avoided a medication error because of system alerts In addition, slightly less than half reported better counseling of adverse effects and improved monitoring. (Despite this only 47% reported satisfaction with the system. Complaints included alerts regarding medications discontinued, alert fatigue, and alerts inappropriately identifying drug interactions.)
Implementation of a web-based laboratory information system to treat multi-drug resistant tuberculosis patients in Peru greatly improved timely access to lab results and user satisfaction. The system was expanded to other institutions based on its success to serve a network for over 3.1 million patients. The system is at relatively low cost amounting to 1% of National Peruvian Tuberculosis annual budget.

Population Health
Population based surveillance system in a large multicenter primary care network identified patients overdue for mammography screening. The interventional study showed that providers successfully contacted 63% of over 3,000 patients at risk.
A computer based smoking cessation program designed after extensive review of the literature on the barriers associated with such a program, was found to be effective, inexpensive and required little time or skill from staff. The program was continued following the conclusion of the study because of the satisfaction rates from providers and patients.
Study showed feasibility and reliability of EHR based chronic kidney disease (CKD) registry composed of 57,276 patients in accurately relaying demographics and most comorbidities when compared to individual EHR chart review (κ >0.80). Study concluded such a registry has the potential to improve quality of care in this patient population and contribute to the development of a national CKD surveillance project.

Care Coordination
A study assessing the effect of a medication reconciliation program in an ambulatory oncology clinic found at least one error in 81% of all patients’ medication lists. In the group that received the intervention, 90% of incorrect medication lists were corrected, while only 2% were corrected in the control group (p < 0.001).
2007 cross-sectional survey of US home health and hospice agencies found 33% increase in use of EHRs since 2000. The agencies used available EHR functionalities in general, including telemedicine and information sharing..

Efficiency
Antibiotic approval system guiding use of 28 restricted antibiotics improved appropriate use of antibiotics and led to increased susceptibility of S. aureus to methicillin and of pseudomonas to several antibiotics. Patients with gram negative bacteremia did not suffer increased adverse outcomes as a result.
An interventional study (n=2200) compared RBC transfusions in critically ill patients before and after evidence based CDS intervention significant decrease in number of RBC transfusions per patient and percentage of patients transfused (p = 0.045 and p = 0.01 respectively) and net savings of almost $60,000 (n=1100 patients).