NJ Health Information Technology Commission Meeting: Feb 3, 2011

February 3, 2011 3:00pm to 5:00pm
Location: Auditorium on the first floor of the Department of Health and Senior Services Building, 369 S. Warren St, Trenton, NJ.

1.Call to Order
2.Committee Reports and/or Review of Committee Scorecards
          a.Privacy and Security Committee (up to 40 minutes) – Committee Chair
                     i.Review of Report/Dashboard
                    ii.Announcement – new Co-Chairs
          b.Committee Membership status
3.Status on State HIT Operational Plan
         a.Recent $11.4 million ONC awards and immediate next steps – (15 minutes) – Colleen Woods
         b.Project Management assistance – Colleen Woods
4.New and Unfinished Business
         a.Dialogue with Constituencies (10 min) – Al Campanella
         b.Promotion of e-Prescribing (5 min) – Colleen Woods
         c.Vision of the Innovation Center (5 min) – Colleen Woods
5.Housekeeping Items
         a.File-Sharing Website (5 min) – Al Campanella
         b.Update on Public NJ HIT Commission Website – Colleen Woods
6.Public Comment Period

Documents from January 2011 NJ HIT Commission Meeting
Alfred Campanella, Chair NJ HIT Commission: Chair’s Reflections and Direction. January 2011 [pdf 358k]
Colleen Woods, NJ Statewide HIT Coordinator: Presentation to HIT Commission, January 2011 [ppt 275k]

New Jersey: 20th State to Receive ONC Approval for HIE Operational Plan

ONC Approves 20th Strategic and Operational State HIE Plan: New Jersey
On January 13, 2011, the Office of the National Coordinator for Health IT approved the operational portion of the State of New Jersey’s Strategic and Operational Plan for Health Information Exchange. This should lead soon to a release of funding for the first of four years of the plan. Previously only planning funds were released. Total Award Amount for New Jersey is $11,408,594. NJ-HITEC, New Jersey’s Regional Extension Center (REC), has already been awarded $23,048,351. Funds for HIE and REC programs are released based on reaching specific milestones.

List of Approved Plans on ONC’s State HIE Program site
New Jersey Strategic and Operational Plan–ONC Summary [PDF]

Following are excerpts from the first five of six pages ONC released summarizing the NJ program. The sixth page is an HIE Inventory, enabling easier comparisons with other state programs.

Health Information Exchange
Strategic and Operational Plan Profile

The State of New Jersey is committed to building on existing health information technology and exchange investments in developing a strategy for providers in the state to meet the EHR Incentive Program meaningful use requirements. It has developed a strategy for health information exchange that includes first strengthening exchange in local nodes and then creating a “network-of-networks” linking four regional health information exchange organizations (RHIOs) to create statewide coverage.

Model and Services
The New Jersey plan builds the capacity of local/regional exchange efforts. The state will use a large portion of the funds to support four local RHIOs in increasing data liquidity and supporting providers in achieving meaningful use. The work to strengthen the capacity of local exchange will be paired with strategic policy and operational interventions to increase lab data liquidity and e-prescribing participation statewide:
• Enable lab results delivery from Quest Diagnostics using the NHIN Direct specifications.
• Implement regulations that will require commercial and private laboratories to make electronically interfaced laboratory result transactions available to physician EHRs and regional HIEs at no extra cost to physicians.
• Implement a statewide education program on e-prescribing that targets the 15% of pharmacies not currently enabled for this functionality. This includes identification and monitoring of the targeted pharmacies.
In a later phase, that state will support node to node exchange and other services. The planned statewide services will include:
• Statewide broker/backbone that will connect HIEs
o Record locator services to find location of patient records across the state
o Patient health record services
• State-provided data from key registries (Immunization, Lead, Public Health, etc.)
• State-provided data on Medicaid Medication History
• State-provided Master Patient Index/Master Client Index (MPI/MCI)
• NJHIN stored “master” Record Locator Service for Standalone
EHRs and out-of-state provider access

• Supporting Innovation: New Jersey has a special focus on incentivizing creative innovation within the state. They have established the HIT Innovation Center which is a partnership between the St. Barnabus healthcare system and the New Jersey Institute of Technology. There is a program under development to use NJIT students to create and develop HIT applications as well. The HIT Coordinator Office, the NJ-HITEC and the Innovation Center will be sponsoring an Innovation Summit in early 2011 to feature pilot projects already in place as well as special projects for future consideration. They also continue to emphasize and support a number of innovative projects currently in place across the state including:
o Meridian Home Health Pilot
o Bergen Regional Center Behavioral Health Pilot
o Virtua – Personal Health Records
o St Joe’s – Telemedicine

• Advancing Multi-State Collaboration: New Jersey has expressed an interest in leading new multi-state coordination activities for the mid-Atlantic region. All multi-state HIE coordination initiatives New Jersey is exploring will be in accordance with NHIN standards for communication and interaction. These include:
o Hosting a multi-state collaboration event – New Jersey plans to host its own multi-state collaboration event with surrounding states, to focus on sharing of plans and establishing an interstate approach for secure HIE.
o Project Management focus on multi-state pilots – New Jersey plans to assign full-time project management support to oversee and coordinate several interstate secure HIE pilot initiatives.
o Regional HIE data exchange – Three regional HIEs (South Jersey HIE, the Virtua HIE, and the South Jersey Health System HIE) have plans to exchange data in late 2010/early 2011 with Fox Chase Cancer Center’s HIE, located in Philadelphia, Pennsylvania.

[ONC issued new guidance to State HIE Programs on July 6, 2010, in the form of a Program Information Notice, which established "The immediate priority of the State HIE Program is to ensure that all eligible providers within every state have at least one option available to them to meet the HIE requirements of meaningful use in 2011... (and therefore) states and SDEs shall outline in their State Strategic and Operational Plans (state plans) a concrete and operationally feasible plan to address and enable these three HIE capabilities in the next year:
1. E-prescribing
2. Receipt of structured lab results
3. Sharing patient care summaries across unaffiliated organizations]

NJ E-Prescribing Landscape
As of the end of 2009, there are 1,609 community active pharmacies capable of filling e-prescriptions. This figure excludes hospital pharmacies, but includes both chain and independent facilities (both retail and closed) and represents an 85% adoption rate across pharmacies in New Jersey. A total of 2,696 physicians routed prescriptions electronically in New Jersey, representing a 15% e-prescribing adoption rate for physicians in New Jersey.
NJ E-Prescribing Strategy
The State HIT Coordinator’s office, working NJ-HITEC, the NJ Dept of Health and Senior Services, and state associations, will develop a new program tentatively titled “ePrescribing New Jersey” to target pharmacists, clinicians, and consumers. In January, the state will develop the list of pharmacies who do not offer ePrescribing by matching Surescripts’ list of ePrescribing pharmacies against the NJ Board of Pharmacy’s list of all licensed pharmacies in the state. In February, the Coordinator’s office, working with the Department of Health and Board of Pharmacy will develop information on ePrescribing in the form of a course, handouts, and Web pages (part of the state HIT Coordinator’s Web site). In March, the state and REC will coordinate the start of a series of educational sessions with the HIEs to target non-eRx pharmacies, consumers, and clinicians.

NJ Structured Lab Results Landscape
New Jersey has 5,703 Clinical Laboratory Improvement Amendments (CLIA)-recognized laboratories with various certifications. Of these, there are 85 CLIA-accredited independent clinical laboratories, 4,079 recognized physician office laboratories, and 134 CLIA-accredited hospital-based clinical laboratories in the State.

Electronic sharing of laboratory orders and results within hospitals is already a generally accepted practice for all hospitals in New Jersey.

National laboratories have a large presence in New Jersey. These laboratory companies provide connectivity solutions to many state hospitals and healthcare providers for the exchange of electronic lab orders and results. Three of the largest independent clinical laboratories in New Jersey (Quest Diagnostics Inc., Laboratory Corporation of America, and Bio-Reference Laboratories) are able to directly interface with numerous electronic health record (EHR) systems. These interfaces allow for EHR systems to send lab orders electronically and receive results that can be downloaded directly into the EHR. Other connectivity solutions offered by laboratory companies in the State include proprietary portals for requesting lab orders and receiving results.

While the capability to exchange lab orders and results exists within the State, healthcare providers and regional health information exchange organizations have had varying levels of success incorporating laboratory data from commercial laboratory companies into their electronic health information exchange environments. Hospitals and health information exchange organizations that want to exchange lab data with independent laboratories are required to build custom interfaces to support these integration points and to incur ongoing transaction costs. The resulting drain on monetary and human resources for these point-to-point interfaces for electronic laboratory data exchange continues to be an adoption-limiting factor in the State.
NJ Structured Lab Results Strategy
New Jersey will approach the adoption of electronic transmission of lab results by leveraging the NJHINT law S323 and the regulations already in place for the electronic reporting of medical data to the NJ Department of Health and Senior Services. The Office of Statewide HIT Coordinator will pursue statutory and regulatory avenues in 2010/2011 that will require commercial and private laboratories to make electronically interfaced laboratory result transactions available to physician EHRs and regional HIEs at no extra cost to physicians (replacing traditional means such as faxing of results).

NJ Patient Care Summary Landscape
There is minimal current activity in the state related to the sharing of patient care summaries.
NJ Patient Care Summary Strategy
New Jersey is taking several approaches to enable this requirement. The primary mechanism is to pursue certification processes and participation agreements with the HIEs that will require them to support the exchange of Patient Care Summaries (PCS) with Physician EHRs and other HIEs in order to be eligible for state-sponsored funding and related state benefits.

NJ Health IT Commission: Jan 6 Starts New Schedule, New Chair for 2011

New Jersey Health Information Technology Commission
January 6, 2011                 3:00 to 5:00 pm

Meeting Agenda [PDF Version]
Auditorium, 1st Floor, Health and Agriculture Building,
369 S. Warren St
Trenton, NJ

1. Introductions

2. Colleen Woods, NJ Statewide Health Information Technology Coordinator:
Status on the State HIE Plan and key areas for the Commission’s direction

3. Alfred Campanella, Chair NJ HIT Commission: Chair’s reflections on Commission’s role and direction

4. Discussion on approach for stakeholder inputs (Consumers, Hospitals, Payors, etc.) and the role of Commission members

5. Housekeeping items: Meeting times, intra-Commission communication

6. Public Comments

Schedule of 2011 HIT Commission Meetings
First Thursday of each month.
January 6, 2011
February 3, 2011
March 3, 2011
April 7, 2011
May 5, 2011
May 5, 2011
June 2, 2011
July 7, 2011
August 4, 2011
September 1, 2011
October 6, 2011
November 3, 2011
December 1, 2011

Colleen Woods Asks “Where are the NJ Healthcare Innovators?!!”

From: Colleen Woods, NJ Health IT Coordinator
To: New Jersey Healthcare Innovators,
NJ Health IT Community
Re: Calling for Innovations for Supplemental ONC Funding
Date: Dec 21, 2010
High Priority
Most of you are aware that the Office of the National Coordinator issued a supplemental funding opportunity to the State Health Information Exchange Cooperative Agreement Program.  As required, on December 10th,2010,  I responded that New Jersey would apply for the supplemental funding, knowing that we have many exciting projects in place that could be advanced with just a bit of additional funds.

There are five challenge “themes” that the feds view as potential barriers to full national health information exchange. They are seeking innovative ideas/solutions from those of you who know healthcare delivery the best.  The themes are:
  • Achieving Health Goals through Health Information Exchange
  • Improving Long Term and Post Acute Care Transitions
  • Consumer Mediated Information Exchange
  • Enabling Advance Query for Patient Care
  • Fostering Distributed Population-Level Analytics

For more information please see a PDF of the  ONC’s funding announcement: http://goo.gl/oGc7Q

Or to see all the funding documents, go to Grants.gov:http://goo.gl/0dk3i

I know there are a lot of good ideas and projects already underway that would qualify for this funding opportunity. (Jeff, Becky, Jim, Tom, Dave, Tom, Linda, Lou, Judy, Neal, Al, Bob et al…..) , but the award requires a quick response.  Applications need to be sent to by the NJ State Coordinator’s Office ONC by January 5th, 2011. I would proud to submit any ideas you have that would meet the ONC challenge.  Please feel free to call me to discuss.

My best wishes to you and your families for a Happy Holiday Season!


Colleen Woods
NJ Health IT Coordinator
Governor’s Office

Synopsis of the Supplemental State HIE Challenge Program
“This funding announcement for the Health Information Exchange Challenge Program encourages breakthrough progress for nationwide health information exchange in five challenge areas identified as key needs since Federal and State governments began implementation of the HITECH Act. The awards will fund the development of technology and approaches that will be developed in pilot sites and then shared, reused, and leveraged by other states and communities to increase nationwide interoperability. The five themes include: 1. Achieving health goals through health information exchange 2. Improving long-term and post-acute care transitions 3. Giving patients access to their own health information 4. Developing tools and approaches to search for and share granular patient data (such as specific lab results for a given time period) 5. Fostering strategies for population-level analysis Awards will range between $1 million and $2 million each, and will be in the form of supplemental funding to State Health Information Exchange Cooperative Agreements, which have provided approximately half a billion dollars to states and State designated entities to enable health information exchange. Funding for this initiative is approximately $16 million which ONC anticipates will support 10 awards.”
–Synopsis from grants.gov

ONC Listens: BluePrint at ONC Innovations Seminar

ONC Listens: BluePrint at ONC Innovations Seminar
On October 25, 2010, the ONC Innovations Seminar was led by BluePrint Healthcare IT in Washington, DC. The one-hour seminar entitled “HITECH in New Jersey: A View from the Private Sector” was part of a series featuring people from outside the Office of National Coordinator (ONC) for Health IT sharing their experiences and ideas with the Office. This post reports on how three of my BluePrint colleagues and I got to speak with about twenty members of ONC (including several on a conference line) and share our experiences.

ONC Innovations Seminar
Sachin Jain MD, MBA, Special Assistant to David Blumenthal; and Wil Yu, Special Assistant for Innovation to the National Coordinator, invited the BluePrint team to Washington, DC to lead Monday’s ONC Innovation Seminar. Members of BluePrint had previously worked with the New Jersey and Delaware Valley HIMSS chapters to invite Jain and Yu to speak and meet with attendees at the chapters’ joint fall conference in Atlantic City in September.

Jain initiated the ONC Innovations Series, which in its official description took “place every one to two weeks (for members of the ONC staff) and will bring in noted experts from the health IT community including technologists, patient and community advocates, grantees, academic researchers, government officials and others.”

Seminar leaders have included Michael Porter (Harvard Business School and thought leader on Competitive Advantage), Mark McClelland (former head of FDA and CMS, now heading the Engleberg Center for Health  Care Reform at Brookings), Peter Pronovost  (Johns Hopkins physician and leader in patient safety), Lonny Reisman (Aetna’s chief medical officer), Richard Baron (Philadelphia area physician with Greenhouse Internists) and Rushika  Fernandopulle (an Atlantic City physician).

Case Studies
Speaking with ONC members at its October 25 seminar, BluePrint used three case studies to illustrate health IT challenges and how it was helping hospitals solve them: fast-tracking meaningful use security risk assessments; developing and implementing a workflow software tool to manage access to enterprise-wide software; and setting up a five-stage security and privacy framework at a community hospital to strengthen physician relationships and foster greater trust with patients. It also described its two-hour seminars offered to hospital leadership to prepare for meaningful use and readiness to receive EHR incentive payments.

BluePrint’s Public Policy Role—New Jersey and beyond
The seminar pointed out the new momentum fostered by New Jersey’s health IT leadership—statewide Health IT Coordinator Colleen Woods and Bill O’Byrne, executive director of NJ-HITEC, the state’s regional extension center. New Jersey submitted its HIE operational plan to ONC in August, and NJ-HITEC kicked off its clinician sign-up program for meaningful use support in October.

Based on working with hospital CIOs, Vikas Khosla, the President and CEO of BluePrint, described the transformation of hospital and multi-hospital system CIOs from systems implementation and management executives to leaders of healthcare change management. Founded in 2003 to advise hospitals and multi-hospital systems on security and privacy issues, BluePrint has taken on a public policy role as well, including producing a series of workshops on HITECH Breach Enforcement in collaboration with NJ HIMSS and having Vikas serve as a subject matter expert for the state HIT Committee on Privacy and Security.

The ONC’s Listening Continues
This seminar series demonstrates one way ONC listens and learns. Another example, for which registration just opened this week, is the Personal Health Record Roundtable on December 3 in Washington, DC, to be chaired by HHS Chief Privacy Officer Joy Pritts. The roundtable will hear panels of “researchers, legal scholars, and representatives of consumer, patient, and industry organizations” in order to prepare recommendations, as stipulated in HITECH Act,  “related to the application of privacy and security requirements to non-HIPAA Covered Entities, with a focus on personal health record vendors and related service provider.”

To the readers of e-Healthcare Marketing,  who are used to seeing this blogger’s collections of information and reports about Health IT and EHRs, thank you for taking the time to read about  the Washington trip of Vikas Khosla, President and CEO; Gregory Michaels, Director, Security and Compliance Solutions; Mohit Pasricha, Chief Solutions Architect, and me, Mike Squires, Vice President, Strategic Development and Public Policy, BluePrint Healthcare IT www.blueprinthit.com .
Mike Squires

Scan for Health IT Innovation Pilot Programs in New Jersey: What Pilots Do You Know About in NJ? Due Sept 21

New Jersey: Are you involved with or know of Health IT Innovation Pilots Programs in NJ?
Tuesday noon, September 21, 2010 Deadline

New Jersey’s Statewide Health IT Coordinator, Colleen Woods, is asking for your immediate help in gathering a list of  Innovative Health IT Pilot Programs in the state. Do you or your organization have an ongoing pilot program that involves health information technology? Are you planning a specific innovative pilot program involved with Health IT? Or do you have experience with a past program in NJ?

Think broadly: health IT pilot programs in hospitals, long-term and critical care facilities, physician and clinical offices, pharmacies, home health, remote monitoring and self-monitoring, electronic health records, personal health records, wireless, online and digital.

Please let us know. This will help pull together some additional information in time for next week’s NJ and Delaware Valley HIMSS Conference on Sept 22-24, 2010 in Atlantic City. You can add comments to this blog or email Mike Squires at msquires@e-healthcaremarketing.com with whatever information you can share. I’ll be sure to get it to Colleen Woods.   Thank you very much!
–Mike Squires

NJ Health IT Commission Meeting: Sept 2, 2010, 3:00pm

New Jersey Health Information Technology Commission
Thursday September 2nd 2010, 3-5 PM

Auditorium, 1st Floor, Health and Agriculture Building, Trenton, NJ
AGENDA  PDF version
1. Dr. Kennedy Ganti, Chair, NJ HIT Commission – Overview – 5 minutes
2. Doug Struyk and Jennifer DiAngelo- Christian Medical – Long Term Care Facility-EMR Success Story – 30 minutes
3. Dr. Michael Riccards- Director, Hall Institute for Public Policy- Introduction and Collaboration with NJ HIT Commission – 15 minutes
4. Dr. Steve Green- Director, Office for eHIT Development, NJ DOBI – Update – 15 minutes
5. Dr. Simi Octania-Pole, Director of Data Systems and Evaluation, Division of Epidemiology, Environmental and Occupational Health NJ DHSS – CDRSS presentation – 20 minutes
6. Dr. Kennedy Ganti – Public Outreach – 20 minutes
7. Public Comments

New Jersey Sends HIE Operational Plan to ONC

New Jersey Health Information Exchange Operational Plan: August 13, 2010
Includes Map of Current HIE Landscape

New Jersey sent its Operational Plan for State  Health Information Exchange Cooperation Agreement to the Office of the National Coordinator for Health IT on August 13, 2010. Per the report, New Jersey submitted its initial “State HIT Plan in October 2009 with an additional update in January 2010.” Plan is posted on NJ Health IT Commission Web site, with excerpts below which include the cover letter from NJ State HIE Coordinator Colleen Woods and the Executive Summary.

[Clicking on any of the four figures will give you a clearer view of those figures.]
Operational Plan PDF [2.2M]
NJ State HIT Operational Plan 2010

August 13, 2010  

David Blumenthal MD, MPP
National Coordinator for Health Information Technology
Department of Health and Human Services 
Washington, DC 20201

Dear Dr. Blumenthal:
Attached is New Jersey’s HIT Operational Plan which represents a continuation of our planning efforts started in 2009 with the submission to the Office of the National Coordinator for HIT of our State HIT Plan in October 2009 with an additional update in January 2010. Our Operational Plan represents a significant collaborative effort that included:  

  • New Jersey State Medicaid leadership
  • Director of NJ-HITEC, our Regional Extension Center
  • Executive Director of the New Jersey HIT Commission
  • Director of the New Jersey Office for eHIT Development
  • Leadership from our four funded HIEs
  • Leaders from several unfunded HIEs
  • Representative from New Jersey Hospital Association

I am very pleased with the result and believe this represents a significant step for the State of New Jersey in bringing fundamental change in the delivery, quality, and value of healthcare in the State. With this Plan we bring:   

  • A re- commitment for New Jersey to be a national leader in HIT
  • A drive to leverage and harness health information to improve, monitor and protect the health of our citizens
  • A goal to meet and exceed Federal mandates for each person to have an electronic health record by 2014

As the New Jersey Statewide HIT Coordinator I am committed to working with all state departments and agencies, the healthcare provider community, and other key stakeholders, to implement and facilitate the HIT Strategic and Operational Plans for New Jersey in accordance with nationally recognized Federal standards.We look forward to your timely review and approval of our HIT Operational Plan and continued collaboration on this vital issue for our country and for the State of New Jersey. We also request timely release of implementation funds for our four ONC funded HIEs. 

Ms. Colleen Woods 
New Jersey Statewide HIT Coordinator 

Submitted August 13, 2010


This HIT Operational Plan serves as the approach and schedule to implement New Jersey’s Strategic HIT Plan previously submitted in October 2009 and further refined in January 2010. Execution of this Plan will enhance the quality, delivery, and value of healthcare while supporting New Jersey’s hospitals and eligible providers in achieving and demonstrating meaningful use of Health Information Technology (HIT). The State acknowledges that the HIT and HIE landscape at the federal and state levels is evolving, and that this is a living document requiring ongoing review, changes, and refinement. Our plan, by design, is nimble and adaptable to the expected changes and evolution of HIT strategy. 

A Unique Approach - Our approach, depicted in Figure 1.1 below, builds on existing, long-standing HIT projects across the State combined with newly funded ARRA initiatives to ensure that all expenditures and resources are leveraged in one cohesive, strategic plan. Recognizing that complex and functional HIT systems are already established, and that expertise is available and willing to be shared, building our plan on a “ground-up” strategy makes perfect sense. Realizing that barriers do exist, our leadership is committed to identifying and eliminating barriers, while ensuring that duplication of effort and expenses are avoided. NJHIN Figure 1.1
Figure 1.1 New Jersey Health Information Network (NJHIN) 

Our approach recognizes that this is a time of unprecedented change in the Heath Information Technology landscape. Simultaneously, the following conditions and projects are occurring across New Jersey:  

  • Community-based physicians are moving to better understand the impact of adopting certified electronic health record (EHR) technology in order to be eligible for “meaningful use” incentives.
  • Hospitals are expanding and upgrading their IT systems to ensure “meaningful use” eligibility as well.
  • The newly created regional extension center, the New Jersey Health Information Technology Extension Center (NJ-HITEC) has begun to assist physicians in understanding EHR technology, selecting technology vendors and becoming eligible for “meaningful use” incentives.
  • Four ONC funded regional Health Information Exchanges (HIEs) are in various stages of becoming incorporated, developing solution strategies and building/testing new infrastructure. Health-e-cITi-NJ has been incorporated as a 501(c)(3) organization. Jersey Health Connect has been incorporated and is awaiting 501(c)(3) designation.
  • No less than eight distinct HIE models have been identified throughout the State that are in a position to be leveraged into the state plan.
  • New Jersey Medicaid is progressing toward its own HIE model and has begun implementation of a crucial Master Client Index project.

The New Jersey Health Information Network (NJHIN) will integrate these various projects and initiatives. In effect, NJHIN consists of a “network of networks” in which centralized shared services will provide: 

  • A focal point for accessing state-managed data (e.g., various state registries).
  • A record locator service (RLS) for locating records within the four new regional HIEs, the Medicaid HIE and the other existing HIE initiatives across the State.
  • A conduit to the federal NHIN Direct and NHIN Connect networks.

Key aspects of the NJHIN include: 

  • Leveraging of significant work in progress through a “ground up” collaborative effort between state HIT leadership and several community-based healthcare organizations within the State.
  • A multi-track effort leveraging Medicaid capabilities and funding, local HIE leadership, provider capabilities, NJ-HITEC services, and overall state HIT leadership.   
  • A centralized approach where appropriate, e.g., Master Patient Index/Master Client Index, while leveraging community based innovation and leadership.
  • NJHIN will leverage Medicaid and all the MMIS medical history data that already exists for ~1.3M citizens in our state representing 15% of our population.

Significant effort and investment have already been made in evolving the NJHIN. The release of implementation funding for the four approved HIEs will accelerate the realization of the NJHIN.

Continuing Our Leadership – New Jersey has been in the forefront of promoting electronic health records. Some historical context includes: 

  • New Jersey’s active interest in electronic systems as a means of increasing healthcare quality and reducing costs began in 1993 through a study to analyze current methods, barriers, and recommendations for achieving savings and administrative simplification in the New Jersey healthcare system.
  • This led to the passage of the New Jersey Health Information Network and Technology (HINT) law in 1999 which set a precedent for health information technology standards for interoperability in the Garden State.
  • During 2004-2005 the New Jersey Hospital Association began facilitating discussion focused on HIE development and deployment. This led to the emergence of several community-based HIE initiatives which have become the basis of the current NJHIN.
  • As early as 2004, some New Jersey hospital systems began developing HIE models, primarily within their corporate structures, and have accomplished sophisticated health information sharing solutions that are ready to be integrated into the statewide plan.
  • In 2008 the New Jersey Health Information Technology Act was passed which mandates the creation of a plan to implement a secure, integrated, inter-operative and statewide infrastructure for the sharing of electronic health records. The Act also created a Health Information Technology Commission to oversee the development, implementation and oversight of the plan, in partnership with the Office for eHIT Development.
  • In October 2009 New Jersey submitted one of the first State HIT Plans to ONC and received initial approval of the four requested HIE implementation grants.
  • In March 2010, through a transformation grant from CMS, the New Jersey Division of Medical Assistance and Health Services (DMAHS) initiated a project to build Phase I of our Master Patient Identifier (MPI) capability which will promote the critical interoperable exchange of Medicaid, Immunization, and Blood Lead Screening databases among New Jersey’s departments of Health and Senior Services and Children and Families, Managed Care Organizations, Federally Qualified Health Center (FQHC) providers, hospitals and the Department of Human Services.  
    • In March of 2010, DMHAS initiated a Planning APD to CMS to secure planning funds to begin the State Medicaid HIT Plan (SMHP) that will be leveraged and integrated into the statewide planning process. 
    • Implementation planning is underway for the NJ-HITEC which will promote broad-based adoption of electronic health records. Funding for this effort was received in mid-2010.  

Our leadership continues at the national and state level as we aggressively move forward in transforming the healthcare delivery system of New Jersey.

Our Fundamental Strategies – In addition to supporting the strategic direction articulated in our State HIT Plan submitted in October 2009, the following represents the fundamental strategies for our HIT Operational Plan. These strategies include the following:  

  • Medicaid is a key partner in the execution of this HIT Operational Plan and we will leverage CMS funding to help build the infrastructure for statewide health information exchange.
  • A core tenet of the program is the elimination of disparities of care by ensuring that underserved communities, including children, are represented in evolving HIT/HIE efforts. We must also be aware of the potential for a “digital divide” between more affluent segments of the population and those who are underserved.
  • We will leverage our 98% broadband coverage (#1 in the US) to ensure all providers and healthcare service recipients have access to the right information at the right time.
  • We will leverage all funding sources (public and private) to ensure the financial viability and stability of the HIT program.
  • Through effective HIT coordination we will eliminate duplicative efforts and projects across the HIT landscape and ensure efficiency of efforts by centralizing and sharing policies, standards, and infrastructure as appropriate.
  • We will effectively manage the transformational change in the New Jersey healthcare community through the efforts of the NJ-HITEC and the Office of the Statewide HIT Coordinator. 

Coordinating Our Efforts – Ms. Colleen Woods has recently been named as New Jersey’s Statewide HIT Coordinator. Among her many outstanding qualifications Ms. Woods was most recently the CIO for the New Jersey Department of Human Services providing technology direction to the State Medicaid Program. With her selection, we have adjusted our overall governance structure for the HIT Program pertaining to HIT direction and policy. As depicted below the Program is wide-ranging with a varied and complex set of stakeholders.    

NJ HIT Program Context Figure 1.2
Figure 1.2 New Jersey HIT Program Context  

Effective governance is essential. Given this context we have designed and implemented a governance capability to drive successful program performance and results.  

NJ HIT Program Governance Figure 1.3Figure 1.3 New Jersey HIT Program Governance 

The ongoing transformation of the healthcare system in New Jersey from a paper-based healthcare information environment to a digital healthcare information environment is complex and will require collaboration between multiple parties with potential conflicting interests. We are confident our approach will build upon our early successes in bringing together the necessary constituents (both public and private) to continue the transformation to provide access to reliable healthcare information that improves the quality and efficiency of care.  


As described in this Operational Plan, the State acknowledges and accepts the following HIT program responsibilities:  

  • To ensure alignment with Medicaid and other public health programs.
  • To design and manage a transparent multi-stakeholder process to guide and implement the program.
  • To monitor and track meaningful use of HIE capabilities through a well-coordinated and effective communication process.
  • To ensure the accuracy, security, and privacy of personal health records.
  • To assure all stakeholders that information sharing is consistent with state and federal security and privacy provisions.
  • To ensure effective gap closing strategies related to HIE capabilities for meaningful use exist and are effectively managed.
  • To educate the public (patients and providers alike) to understand, embrace, and realize the benefits of EHR technology.
  • To take the lead in developing statewide, standardized policies and procedures that are consistent with those established at the national level.

In addition to the technical aspects of establishing the NJHIN, the HIT Operational Plan addresses the regulatory, financial sustainability, governance, and project management approaches to effectively implement our strategies. The sections that follow begin with the HIT Operational Plan requirements (highlighted) from the State Health Information Exchange Cooperative Agreement Program Funding Opportunity Announcement (FOA) and the related Program Information Notice (PIN), dated July 6, 2010, followed by our response.  

This HIT Operational Plan is submitted to the Office of the National Coordinator for Health Information Technology (ONC) for review and approval.

HIE Landscape in New Jersey
[Clicking on the map below will give you a clearer view of the map.]
HIE Landscape of New Jersey Figure 9.1

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For strategic and operational plans from 25 other states, please see updated post on e-Healthcare Marketing.

NJ Regional Extension Center Launches Site, Announces RFPs

NJ-HITEC Sets Schedule for EHR Vendor RFRs (Request for Response),
Letters of Intent Due Aug 18
Excerpted from NJ-HITEC Web site on August 13, 2010.



“New Jersey – Health Information Technology Extension Center (NJ-HITEC) is a federally recognized Regional Extension Center located on the campus of the New Jersey Institute of Technology. The sole purpose of NJ-HITEC is to assist New Jersey primary care providers in the successful adoption, implementation and use of electronic health records systems and to become meaningful users of those healthcare technologies, in order to deliver quality care improvements to New Jersey residents throughout the state.”

[The  NJ-HITEC "website is currently under construction. Please be  sure to check back frequently as" they update and expand the site.]

Schedule for Response for Supported EHR Vendors
Letter of Intent Due Aug 18;  RFR Due Aug 27
FAQ Session Aug 20

Event Date
NJ-HITEC releases RFR August 13th, 2010
E-mail letter of Intent Due by 5 pm August 18th, 2010
Last day for Vendor Questions – Vendor FAQ session August 20th,  2010
Answers Posted on Website August 24th, 2010
RFR Due August 27th, 2010
Vendor Demonstrations & Site Visits September & October, 2010

Excerpted from Request for Response (RFR) for
Supported EHR Vendors on August 13, 2010:
NJ-HITEC was setup “to support and serve health care providers in becoming meaningful users of electronic health records (EHRs). NJ-HITEC will work towards this goal by:

  • Providing  training and support services to assist doctors and other providers in adopting EHRs
  • Offering information and guidance to help with EHR implementation and achieving Meaningful Use
  • Giving technical assistance as and when needed”

“New Jersey has nearly 33,000 physicians, among which 18,343 of which are primary care providers. NJ-HITEC has been established as a 5.01(C) 3 organization with a mission to convert 5,000 Priority Primary Care Providers (Internal Medicine, Pediatrics, Family Medicine, Adolescent Medicine, OB/GYN, Nurse Practitioners and Physician Assistants) to meaningful users of Electronic Health Record technology in the first two years.   

“This request for responses is being issued to identify and select multiple EHR solutions in order to create a “Supported Vendor List”. This Request for Response addresses NJ-HITEC’s mission to advance the adoption, implementation and meaningful use of health IT among health care providers to improve the safety, quality, accessibility, availability and efficiency of health care for the citizens of New Jersey. NJ-HITEC is seeking vendors whose products are capable of bringing providers to meaningful use in a cost efficient and effective manner and is looking forward to contract with qualified vendors. 

“NJ-HITEC views the selection of these vendors as part of the overall process in New Jersey to create an effective electronic health records system. That system will be accessible to both the individual and to his or her physician, hospital and other health care providers.

“As a part of the qualifying process, respondents may be asked to provide a demonstration of their proposed solutions. The project will be consistent with New Jersey Health Information Technology implementation plan and the NJ Medicaid Management Information System (MMIS) and State Medicaid HIT Plan (SMHP) plans.”

The Vendor FAQ conference call will be held on
August 20th, at 11 am – 12 pm EST.
Conference Call Number: 218-936-7988
Passcode: 211

Request for Response for EHR s and Instructions
Documents for Downloads
-RFR Document
-Addendum I
-Addendum II


NJ Health IT Commission Publishes Interim Report: July 2010

New Jersey HIT Commission and the Office for e-HIT Development Joint Interim Report
July 2010
The Interim July 2010 report for  New Jersey HIT Commission and the Office for e-HIT Development was accessed on the New Jersey Health IT Commission Web Page on July 27, 2010. The report’s preface, executive summary, introduction and report scope, and accomplishments sections are excerpted below.
For the full report in PDF format click here

NJ Health IT Commission
NJ Health IT Commission

go the the NJ HIT Commission Web site.

The Health Information Technology Commission, in collaboration with the Office for e-HIT Development, is statutorily obligated to submit an Interim Report to the Governor and the Legislature. The material in this report reflects the continued work in the priority areas of the New Jersey Health Information Technology Commission as determined by the Commission members with input from the Office for Electronic Health Information Technology (e-HIT) Development and the rapidly-changing national landscape of health IT.

Executive Summary
The Health Information Technology Commission was formed by the “New Jersey Health Information Technology Act,” signed into law by Governor Corzine in January, 2008. (A4044/S2728; PL 2007, Chapter 330). Under the law, the Commission and the Office for e-HIT Development in the Department of Banking and Insurance are responsible for collaborating to “develop, implement, and oversee the operation of a Statewide Health Information Technology Plan.”

The Commission is composed of key leaders from the private and public sectors representing the variety of services that compose the New Jersey Healthcare environment. The Commission held its first full meeting in December 2008.

In July, 2009 the Commission realigned its effort in order to respond to the American Recovery and Reinvestment Act of 2009 (ARRA), which contains funding under Part 3010 for the establishment of interoperable systems for Health Information Exchange (HIE). Working with leaders throughout the state, New Jersey submitted a proposal to create four regional health exchanges, for which we received approval in March 2010, resulting in a notice of grant award for $11.4 million.

Also in July, 2009 the Commission voted to form three Committees to develop and track recommendations regarding the important areas of emphasis for the state: Implementation, Policy, and Technology. Each of these committees has completed its first phase and made preliminary recommendations to the full Commission. Efforts to further delineate and refine the recommendations are currently under way. The Commission has also synthesized a variety of reports from both the private and public sectors to better define the healthcare landscape and needs of the residents of New Jersey.

The Health Information Technology Commission, in collaboration with the Office for e-HIT Development, is statutorily obligated to submit this Interim Report to the Governor and the Legislature “concerning its activities and the status of, and actions taken regarding development, implementation, and oversight of the statewide health information technology plan.” The material in
this report reflects the continued work in the priority areas of the New Jersey Health Information Technology Commission as determined by the Commission members with material contribution from the Office for e-HIT Development and the rapidly-changing national landscape of health IT.

Over the past year and a half, the NJHITC has collected, reviewed and integrated a variety of reports and plans in existence throughout the state including the Rutgers HIT Landscape Report commissioned by the Office for e-HIT Development assessing the current state of electronic healthcare information systems, and the Regional Health Exchange Feasibility Study and Model for
creating a state wide HIE commissioned by the New Jersey Hospital Association. The NJHITC addressed the issues pertinent to emergency preparedness through a review of Hippocrates, New Jersey’s state of the art, real-time, electronically integrated emergency preparedness response system program. The NJHITC and Office for e-HIT Development also reviewed the New Jersey Department of Health and Senior Services’ plan to rollout technology to Federally Qualified Health Centers, the meaningful use criteria defined by ARRA HITECH regulations, and plans to create an interstate immunization registry with New York and Pennsylvania.

These projects serve as a background for the overall statewide plan. In addition the Commission and the Office for e-HIT Development worked with the Camden Coalition to explore process improvements in health quality and cost savings in underserved urban communities through robust health data collection. The subcommittee on Policy ran a public forum and synthesized a manual of privacy policy needs and recommendations, as well as completed a preliminary analysis of Selected
New Jersey Confidentiality and Patient Approval Regulations attached to this Report as Appendix D.

The Implementation subcommittee assembled sound recommendations for the implementation of technology in physician offices and outlined best practices for implementing health information technology. The Technology subcommittee formed recommendations for standards and infrastructure which are the groundwork for moving the plan forward.

All of this effort afforded the Commission the opportunity to contribute to the ARRA grant funding effort, and facilitate attainment of the grant award by the State of New Jersey.

As we move forward, the Commission subcommittees will further develop recommendations and advance the statewide HIT plan along with the guidelines offered by our federal partners. To encourage continued progress, the Commission will maintain focus on the following foundations for success:
          Foster the quality of care
          Protect the privacy of individual health information
          Ensure the accuracy of health data
          Encourage innovation
          Incorporate all healthcare related entities

Introduction and Report Scope
The acquisition and deployment of Health Information Technology (HIT) and Health Information Exchange (HIE) throughout the healthcare system(s) in New Jersey offer a momentous opportunity to make substantial progress in improving the health of our citizens. The direct benefits include: improved patient safety and healthcare quality, enhanced public health, healthcare cost reduction, improved access to care, and greater consumer engagement and empowerment. It is vitally important
that the State of New Jersey have a strategic vision for both the implementation of information technology and a system of connectivity that will provide for the free exchange of information among providers throughout the state. Health IT is a pillar of our healthcare system—and will be increasingly central to health-care reform.

This Interim Report provides a landscape summary of health IT, a description of long-term goals, initiatives undertaken to date regarding the state plan and its implementation — including the state’s successful ARRA grant application — and recommendations to help achieve those goals. Working with other state agencies, on Oct. 16, 2009 the Commission submitted to the federal Department of Health and Human Services a State Plan in conjunction with a grant opportunity through the American Recovery and Reinvestment Act for the creation of a statewide Health Information Exchange (HIE). The HIE is one component for a state-based model of digital healthcare. The detailed State Plan is available at the Commission’s web site: http://www.nj.gov/health/bc/hitc.shtml.

Our ARRA grant submission was approved for the “Strategic” aspects of our State Health IT Plan ad as a result, the State received a notice of grant award in the total amount of $11.4 million. The tate has received $1 million of the total award for planning activities, but as with 48 other states, the ederal agency is requiring that the State Plan be in full compliance with all requirements before the
remaining “Implementation” funds are released. This will require that certain points in the State Plan be  modified or clarified, as described below.

This interim report represents a review of a process that will continue to evolve over time. Thus, it is both a “look back” and a projection of “future activity.” The transformation of the healthcare system in New Jersey from a paper based health care environment to a digital health care environment is complex and will require collaboration across multiple parties with potential conflicting interests. It is our belief however that working together with public and private parties the State can sustain the
effort to accomplish the transformation and provide access to reliable health care information that improves the quality and efficiency of care.

Working with the Office for e-HIT Development, and the Division of Medical Assistance and Health Services, the New Jersey Health Information Technology Commission (NJHITC) is addressing a broad scope of critical components and workflows in building the blueprint of a statewide health information technology network. These two entities continue to plan a strategy to deploy electronic
health records in physician offices, federally qualified health centers, long term care facilities, hospitals, home health agencies, and other health care delivery settings and connect them electronically to laboratories, pharmacies, state registries, and payers. The Commission also recognizes the valuable role technology will play to enable the optimal use of health care data for clinical research, to improve public health outcomes, and to improve the process and outcomes of patient care in New Jersey. This report focuses on the opportunities and challenges to clinical data exchange at the community and state level and to the adoption of HIT. The American Recovery and Reinvestment Act’s HITECH provision and subsequent funding programs prompted the NJHITC and Office for e-HIT Development to focus their attention on developing a plan for health information exchange so that the State of New Jersey could procure the maximum funding for such activities allowed by federal legislation. The Health Information Exchange is the cornerstone of an overall statewide plan but is not the only aspect of the plan that the NJHITC and the Office for e-HIT Development are working on. It is the intent of the two entities to issue interim reports on an ‘as needed’ basis to inform the
Governor and the Legislature of the State of New Jersey of the ongoing progress to achieve the vision of a statewide HIE and other aspects of the health IT plan.

The following table provides a list of recent Health Information Technology (HIT) accomplishments by the State of New Jersey. These accomplishments contribute to the state’s overall HIT program vision, a foundation upon which the state’s health information program will be built and transformed to enable the exchange of Electronic Health Records (EHRs) and improve health outcomes statewide.

The HIT accomplishments table is divided into six focus sections that represent key foundational areas necessary to build a successful statewide HIT program. They are as follows:

• Organization and Governance – This area addresses recent organizational changes and project governance now in place to lead and govern HIT for the state.

• Transformation Planning – This section provides further details on the plans and funding that has been secured to initiate HIT planning activities and supplement HIE technology infrastructure needs.

• Technology and Business Transformation – This area includes several major in-process initiatives to support federal directives to address HIPAA compliance and other major improvements.

• Health Information Exchanges – This area lists all active New Jersey HIEs that have been established, each addressing their specific geography and local patient and physician needs.

• Implementation and Transformation Support – This section includes accomplishments to support HIT implementation and sustain program efforts going forward.

• National Involvement – This section includes communication and coordination of activities with other states, participation in national events to share and exchange HIT related best practices and lessons learned.

Health Informatation Technology
(Excerpted from table)

FOCUS: Organization & Governance
Initiative: HIT Commission
Accomplishment: The HIT Commission established four  subcommittees to focus on core areas of HIT implementation and provide recommendations as the state moves forward with its HIT strategy.
          • Policy (including Privacy issues)
          • Implementation
          • Technical Infrastructure

Initiative: HIT Medicaid Strategy & Health Care Reform Focus
Accomplishment: The State has recognized the importance of Medicaid in the overall State HIT program as well as the need to embrace healthcare reform in the state’s HIT vision and strategy planning. A new Executive Director role has been created within the Department of Human Services to focus specifically on the Medicaid State HIT Plan (SMHP) and analyze recent healthcare reform impact on the overall HIT program. The Executive Director will work in close coordination with the State’s HIT Leader.

Initiative: HIT Leadership
Accomplishment: The State has recently created an HIT office and Leader position as part of the Governor’s office. This role will have the responsibility of directing and coordinating all HIT activities across the state. A statewide governance structure will be established and this new office will work in conjunction with the Office for e-HIT within the Department of Banking and Insurance
and the HIT Commission.

Initiative: Electronic Data Sharing Agreements
Accomplishment: Nationally recognized and accepted standard electronic data share agreements were developed and put in place between states. This was endorsed by the National Coordinator for Health IT, CDC and the
American Immunization Registry Exchange.

Initiative: Accreditation Requirements to Protect Citizen Health Information
Accomplishment: DOBI and Office for e-HIT now requires the accreditation of national healthcare clearinghouses, third party billers and third party administrators handling any New Jersey protected health information as to HIPAA and State privacy and security laws, regulations and business practices. This will ensure that the protected health information of our citizens is safe
and secure.

FOCUS: Transformation Planning
Initiative: NJ State HIT Plan
Accomplishment: The state submitted a statewide planning and implementation plan to the Office of the National Coordinator in response to funds available through the American Recovery and Reconciliation Act. The plan effectively established a foundation that leverages 4 Regional Health Information Exchanges, covering the entire state that would implement electronic health records with a ‘bottom-up’ approach. The plan also uses Medicaid as a key partner and leverages CMS funding to build the
infrastructure for statewide HIE.

Initiative: State Medicaid HIT Plan
Accomplishment: The State Medicaid HIT Plan (SMHP) establishes the road map for how the Medicaid agency will promote the use of HIT and electronic health records (EHRs) among Medicaid providers. The first phase of this project is nearing completion, with the delivery of a current landscape assessment, and will be followed by the development of a vision and a set of strategies to drive
the road map. The landscape assessment is a current view of New Jersey’s HIT maturity and will also be leveraged to develop a statewide HIT vision and plan.

Initiative: Funding Received – Planning
Accomplishment: The state received $4.92M from Centers for Medicare and Medicaid Services (CMS) to support the State Medicaid HIT Planning (SMHP) effort.

Initiative: Funding Received – HIEs
Accomplishment: The state received $11.4M from the Office of National Coordinator (ONC) for HIT to support four approved regional HIEs.

Initiative: Funding Received – Regional Extension Center (REC)
Accomplishment: NJIT received more than $23M from ONC to support REC planning and initial implementation support including awareness, training and education. The newly formed REC is called NJ-HITEC, New Jersey Health Information
Technology Extension Center.

FOCUS: Technology & Business Transformation
Initiative: Technology & Master Patient Index
Accomplishment:  This project (started in March 2010) will enable the New Jersey Division of New JerseyMedical Assistance & Health Services (DMAHS) to reliably and accurately maintain a single unique beneficiary identity within the Medicaid enterprise, while also linking Medicaid beneficiary records across various information systems. This will promote the critical interoperable exchange of Medicaid, Immunization and Blood Lead Screening databases among New Jersey’s departments of Health and Senior Services and Children and Families, Managed Care Organizations, FQHC Providers, Hospitals and the Department of Human Services.

Initiative:Immunization Registry Data Exchange
Accomplishment: Electronic exchanges of immunization registry data between States led by the Office for e-HIT between NJ and many other states. This has become the model for a national public health registry data exchange that is being established by the various Health Information Exchanges (HIEs) around the country. (Italics in text refer to corrections.)FOCUS: Health Information Exchanges
     Camden Coalition*
     Northern & Central HIE*
     South Jersey HIE*
     Clara Maass
     Central Jersey HIE
     Trenton HIE
     Virtua HIE
     (*Current ONC funded HIE’s)
Accomplishment: Implementing the HIE infrastructure enables the exchange of health information among the health care organizations and encourages improved efficiency and quality of care. Several HIE’s within New Jersey are in various stages of implementation. Significant accomplishments have been made over the last year including four of the HIEs receiving funding from ONC (indicated by the *). A Roadmap for Statewide Implementation was submitted to the Office of the National Coordinator in May 2010.

Initiative: Mid-Atlantic States – HIE
Accomnplishment: NJ e-HIT has established, at the request of ONC, a preliminary mid-Atlantic states health information exchange involving NJ, NY, PA, DE, MD, DC and VA.

FOCUS: Implementation & Transformation Support
Initiative: Sharing Medication History
Accomplishment: NJ Medicaid began sharing medication history data with the Health-e-ciTi HIE in March 2010.

Initiative: Regional Extension Center (REC)
Accomplishment: NJ-HITEC will support HIT implementation throughout the state including HIT related awareness, training and education. William O’Byrne, former State Coordinator, Office for Electronic Health Information Technology Development, has since retired from the state and has become the REC Executive Director.

Initiative: Stakeholder Analysis
Accomplishment: Excluding patients, there are more than 100,000 entities in New Jersey who are potentially involved, influence, or are impacted by HIT. It is critical to understand the stakeholder involvement and impact throughout the planning and implementation of the HIT program. The goal of the stakeholder analysis is to provide a strategic view of the human and
institutional landscape, and the relationships between the different stakeholders and the issues they care about most.

FOCUS: National Involvement
Initiative:  Multi-State Collaborative
Accomplisment:  New Jersey has been an active participant in multi-state calls sponsored by CMS to share and exchange HIT best practices, lessons learned, etc. New Jersey is also planning its own multi-state collaboration event with participation from 2-3 nearby CMS regions to further exchange and share information.

Initiative: MMIS 2010 National Conference
Accomplishment: State of New Jersey is participating and presenting on several topics related to HIT, HIE and SMHP at the 2010 MMIS National Conference in Portland, Oregon, mid August.

Challenges and Opportunities
Core Recommendations
Sub Committee Recommendations
Principles of HIE Governance
Principles of Sustainability
Principles of Privacy and Security
A – Glossary of Terms
B – Guiding Principles for a Health Information Exchange
C – Use Case Matrix Scores
D – Analysis of Selected New Jersey Confidentiality and Patient
Approval Regulations