**Description of Current, Intermediate, and Desired End States for
Personalized Health Care**

***\[Note:** Content of cells to be brief text/bullets. Cells can be
expanded as needed.**\]***

**Broad Charge:** Make recommendations to the AHIC for a process to
foster a broad, community-based approach to establish a common pathway
based on common data standards to facilitate the incorporation of
interoperable, clinically useful genetic information and analytical
tools into electronic health records to support clinical decision-making
for the health care provider and patient.

**Specific Charge:** Make recommendations to the AHIC to consider means
to establish standards for reporting and incorporation of common medical
genetic test, genomic test, and family medical history data into
electronic health records, and provide incentives for adoption across
the country including federal government agencies.

Goals of the vision:

1.  Agree on what the future should look like from a variety of
    perspectives if the broad charge is realized;

2.  Communicate that vision to key stakeholders for personalized health
    care and HIT to develop a common understanding of our current and
    desired future state of personalized health care and HIT;

3.  Act as a tool to guide future work group deliberations, a work plan,
    and the development of recommendations;

4.  Identify key enablers and barriers to realize progress over the next
    few years.

+-------------+--------------------------+---+----------------------------+
|             | Current State (2007)     |   | End State (\~2017)         |
+=============+==========================+===+============================+
| **          |                          |   |                            |
| Description |                          |   |                            |
| of          |                          |   |                            |
| Consumer's  |                          |   |                            |
| Experiences |                          |   |                            |
| with        |                          |   |                            |
| P           |                          |   |                            |
| ersonalized |                          |   |                            |
| Health      |                          |   |                            |
| Care**      |                          |   |                            |
+-------------+--------------------------+---+----------------------------+
| Consumer's  | -   Emphasis is on       | - |                            |
| Perspective |     treatment and acute  |   |                            |
|             |     care rather than on  |   |                            |
|             |     prevention           |   |                            |
|             |                          | P |                            |
|             | -   Consumers have       | a |                            |
|             |     little interaction   | t |                            |
|             |     with the health care | i |                            |
|             |     setting outside of   | e |                            |
|             |     visits to their      | n |                            |
|             |     doctors              | t |                            |
|             |                          | s |                            |
|             | -   Consumers are        |   |                            |
|             |     fearful that their   |   |                            |
|             |     health information   |   |                            |
|             |     may be used against  |   |                            |
|             |     them for insurance   | a |                            |
|             |     and employment       | r |                            |
|             |     issues               | e |                            |
|             |                          |   |                            |
|             | -   Much of the          |   |                            |
|             |     consumer's knowledge |   |                            |
|             |     of the use of        |   |                            |
|             |     genetic information  | m |                            |
|             |     is in forensics      | o |                            |
|             |     applications         | t |                            |
|             |                          | i |                            |
|             | -   Consumers are not    | v |                            |
|             |     educated about how   | a |                            |
|             |     their information    | t |                            |
|             |     may be used without  | e |                            |
|             |     their consent        | d |                            |
|             |                          |   |                            |
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|             |                          | x |                            |
|             |                          | p |                            |
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|             |                          | c |                            |
|             |                          | t |                            |
|             |                          | a |                            |
|             |                          | t |                            |
|             |                          | i |                            |
|             |                          | o |                            |
|             |                          | n |                            |
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+-------------+--------------------------+---+----------------------------+
| **Defining  |                          |   |                            |
| Attributes  |                          |   |                            |
| of PHC with |                          |   |                            |
| Respect to  |                          |   |                            |
| the         |                          |   |                            |
| Consumer**  |                          |   |                            |
+-------------+--------------------------+---+----------------------------+
| Family      | -   Family history is    |   | -   Family history         |
| History     |     currently collected  |   |     information is         |
| Tools       |     in the health record |   |     organized in a useful  |
|             |     as free text         |   |     format, that includes  |
|             |                          |   |     relationship of the    |
|             | -   Early entry of       |   |     family member to the   |
|             |     family history       |   |     consumer, specific     |
|             |     information in       |   |     disorder, age of onset |
|             |     digital formats is   |   |                            |
|             |     underdeveloped       |   | -   Studies are performed  |
|             |                          |   |     to determine relative  |
|             | -   Information is saved |   |     accuracy of patient    |
|             |     on the patient's     |   |     reported family        |
|             |     computer, printed    |   |     history information on |
|             |     out, and brought in  |   |     a variety of different |
|             |     to the clinician,    |   |     disease states         |
|             |     which does not       |   |                            |
|             |     enable               |   | -   Family history         |
|             |     interoperability     |   |     information is         |
|             |     with other           |   |     seamlessly integrated  |
|             |     electronic health    |   |     through electronic     |
|             |     information          |   |     communication between  |
|             |                          |   |     the PHR with the EHR.  |
|             | -   Family history can   |   |                            |
|             |     be recorded in the   |   | -   Information can be     |
|             |     privacy of the       |   |     securely pulled from   |
|             |     patient's home, with |   |     relative's health      |
|             |     adequate time to     |   |     records, and           |
|             |     consult with         |   |     potentially pushed to  |
|             |     relatives to ensure  |   |     relatives to alert of  |
|             |     correct information. |   |     the identification of  |
|             |                          |   |     a recently identified  |
|             | -   Some risk analysis   |   |     heritable disease      |
|             |     and prevention       |   |                            |
|             |     messages for         |   | -   Networks of databases  |
|             |     specific disease     |   |     containing family      |
|             |     areas are available. |   |     history information    |
|             |     Widespread use of    |   |     can securely message   |
|             |     these tools unknown. |   |     consented information  |
|             |                          |   |     between family members |
|             |                          |   |     if a particular        |
|             |                          |   |     heritable disorder is  |
|             |                          |   |     identified             |
|             |                          |   |                            |
|             |                          |   | -   Importance of          |
|             |                          |   |     providing a "real"     |
|             |                          |   |     (i.e., no secrets)     |
|             |                          |   |     family history and the |
|             |                          |   |     potential risks of     |
|             |                          |   |     information            |
|             |                          |   |     suppression are        |
|             |                          |   |     understood by          |
|             |                          |   |     consumers              |
|             |                          |   |                            |
|             |                          |   | -   Algorithms for many    |
|             |                          |   |     different disease      |
|             |                          |   |     states can input       |
|             |                          |   |     family history,        |
|             |                          |   |     genetic information,   |
|             |                          |   |     environmental factors, |
|             |                          |   |     and behavior to        |
|             |                          |   |     generate personalized  |
|             |                          |   |     prevention messages    |
|             |                          |   |                            |
|             |                          |   | -   Family history         |
|             |                          |   |     information is divided |
|             |                          |   |     into two functions:    |
|             |                          |   |     core elements that     |
|             |                          |   |     most primary care      |
|             |                          |   |     physicians regularly   |
|             |                          |   |     encounter (diabetes,   |
|             |                          |   |     cancer etc) and a      |
|             |                          |   |     modular component with |
|             |                          |   |     tools for specialists. |
|             |                          |   |     All of this            |
|             |                          |   |     information is         |
|             |                          |   |     interoperable to form  |
|             |                          |   |     a complete family      |
|             |                          |   |     history.               |
|             |                          |   |                            |
|             |                          |   | -   Studies are performed  |
|             |                          |   |     to determine effect    |
|             |                          |   |     that family history    |
|             |                          |   |     information has on     |
|             |                          |   |     effecting patient      |
|             |                          |   |     behavior/preemption    |
+-------------+--------------------------+---+----------------------------+
| Personal    | -   Patients can't       |   | -   The PHR contains       |
| Health      |     easily access their  |   |     complete, organized,   |
| Records     |     electronic personal  |   |     quality patient        |
|             |     health information   |   |     information, including |
|             |     or populate a PHR    |   |     genetic and            |
|             |     with their medical   |   |     environmental risk and |
|             |     history.             |   |     exposure data, that is |
|             |                          |   |     actionable for         |
|             | -   Personal Health      |   |     decision making        |
|             |     Records are being    |   |                            |
|             |     offered by a growing |   | -   Patient has            |
|             |     number of health     |   |     responsibility to      |
|             |     plans, employers,    |   |     overcome paternalistic |
|             |     HIT vendors, and a   |   |     system                 |
|             |     few select           |   |                            |
|             |     EHR-enabled          |   | -   Access is ubiquitous   |
|             |     physician offices    |   |     with clinically        |
|             |     but overall adoption |   |     relevant and quality   |
|             |     is very limited.     |   |     health information     |
|             |                          |   |     available in real time |
|             | -   CPS issues are not   |   |     to consumers           |
|             |     clearly understood   |   |                            |
|             |     or addressed by many |   | -   Methods have been      |
|             |     of the PHR vendors   |   |     established for        |
|             |                          |   |     consumers to detect    |
|             |                          |   |     incorrect and          |
|             |                          |   |     incomplete             |
|             |                          |   |     information. Consumers |
|             |                          |   |     have the ability to    |
|             |                          |   |     view and modify        |
|             |                          |   |     information as needed. |
|             |                          |   |                            |
|             |                          |   | -   The PHR enables        |
|             |                          |   |     partnership with       |
|             |                          |   |     providers to reduce or |
|             |                          |   |     eliminate duplicate    |
|             |                          |   |     procedures or          |
|             |                          |   |     processes, save        |
|             |                          |   |     healthcare dollars,    |
|             |                          |   |     and the patient's and  |
|             |                          |   |     provider's time by     |
|             |                          |   |     assisting in           |
|             |                          |   |     preparation for        |
|             |                          |   |     appointments.          |
|             |                          |   |                            |
|             |                          |   | -   Incentives facilitated |
|             |                          |   |     move from paper health |
|             |                          |   |     records to EHRs        |
|             |                          |   |                            |
|             |                          |   | -   Consistent privacy     |
|             |                          |   |     protections are in     |
|             |                          |   |     place regardless of    |
|             |                          |   |     who has what           |
|             |                          |   |     information. A consent |
|             |                          |   |     process enables        |
|             |                          |   |     sharing of information |
|             |                          |   |     for different          |
|             |                          |   |     purposes.              |
|             |                          |   |                            |
|             |                          |   | ```{=html}                 |
|             |                          |   | <!-- -->                   |
|             |                          |   | ```                        |
|             |                          |   | -   Health disparities are |
|             |                          |   |     eliminated/reduced and |
|             |                          |   |     equities are provided  |
|             |                          |   |     (e.g., new             |
|             |                          |   |                            |
|             |                          |   |    pharmacogenetic/genetic |
|             |                          |   |     tests)                 |
|             |                          |   |                            |
|             |                          |   | -   Consumer-friendly      |
|             |                          |   |     information is         |
|             |                          |   |     available to           |
|             |                          |   |     understand knowns and  |
|             |                          |   |     unknowns,              |
|             |                          |   |     implications,          |
|             |                          |   |     surveillance, and      |
|             |                          |   |     intervention options   |
|             |                          |   |                            |
|             |                          |   | -   Information is managed |
|             |                          |   |     to maximize future     |
|             |                          |   |     value                  |
|             |                          |   |                            |
|             |                          |   | -   Consumers are able to  |
|             |                          |   |     use the information in |
|             |                          |   |     selecting insurance    |
|             |                          |   |     that is unique to the  |
|             |                          |   |     individual (i.e.,      |
|             |                          |   |     consumer-driven health |
|             |                          |   |     plan)                  |
+-------------+--------------------------+---+----------------------------+
| **          |                          |   |                            |
| Description |                          |   |                            |
| of          |                          |   |                            |
| Provider's  |                          |   |                            |
| Experiences |                          |   |                            |
| with        |                          |   |                            |
| P           |                          |   |                            |
| ersonalized |                          |   |                            |
| Health      |                          |   |                            |
| Care**      |                          |   |                            |
+-------------+--------------------------+---+----------------------------+
| Provider's  | -   Care of consumers is |   | -   Many chronic diseases  |
| Perspective |     focused on           |   |     are treated with       |
|             |     treatment/acute      |   |     combination therapies  |
|             |     intervention, and    |   |     that are selected and  |
|             |     not on prevention    |   |     custom-designed by     |
|             |                          |   |     tests that determine   |
|             | -   Clinicians cannot    |   |     the most effective and |
|             |     keep up with medical |   |     safe to use. Health    |
|             |     breakthroughs and    |   |     care outcomes are more |
|             |     insufficient         |   |     predictable and based  |
|             |     education about      |   |     less on                |
|             |     genetics in medicine |   |     "trial-and-error."     |
|             |                          |   |                            |
|             | -   EHR adoption slow    |   | -   Health care screening  |
|             |     and expensive, value |   |     and prevention         |
|             |     to the provider is   |   |     strategies are focused |
|             |     not obvious          |   |     on assessment of       |
|             |                          |   |     environmental factors  |
|             | -   Use of clinical      |   |     and genetic markers to |
|             |     decision support and |   |     shape prevention and   |
|             |     other tools to bring |   |     treatment strategies.  |
|             |     evidence to the      |   |                            |
|             |     point of care is low |   | -   Through electronic     |
|             |                          |   |     messaging services,    |
|             |                          |   |     health care providers  |
|             |                          |   |     have rapid access to   |
|             |                          |   |     evidence on new        |
|             |                          |   |     therapies that is      |
|             |                          |   |     aimed at specific      |
|             |                          |   |     patients who may       |
|             |                          |   |     benefit from the       |
|             |                          |   |     latest breakthroughs,  |
|             |                          |   |     thereby accelerating   |
|             |                          |   |     the dissemination of   |
|             |                          |   |     medical research into  |
|             |                          |   |     common clinical use.   |
|             |                          |   |                            |
|             |                          |   | -   Health care providers  |
|             |                          |   |     have medical networks  |
|             |                          |   |     (med-nets) that        |
|             |                          |   |     exchange clinical      |
|             |                          |   |     information about      |
|             |                          |   |     patients that help     |
|             |                          |   |     shape larger knowledge |
|             |                          |   |     management databases.  |
|             |                          |   |     These databases are    |
|             |                          |   |     used to develop        |
|             |                          |   |     electronic reports or  |
|             |                          |   |     profiles of treatment  |
|             |                          |   |     options and plans for  |
|             |                          |   |     patient care.          |
|             |                          |   |     Providers can query    |
|             |                          |   |     these databases to     |
|             |                          |   |     select information     |
|             |                          |   |     about the latest       |
|             |                          |   |     options for care. The  |
|             |                          |   |     networks also alert    |
|             |                          |   |     providers to possible  |
|             |                          |   |     adverse events that    |
|             |                          |   |     are associated with    |
|             |                          |   |     certain interventions. |
|             |                          |   |                            |
|             |                          |   | -   EHRs enable easy and   |
|             |                          |   |     appropriate access to  |
|             |                          |   |     retrospective patient  |
|             |                          |   |     health information.    |
|             |                          |   |                            |
|             |                          |   | -   Interoperable systems  |
|             |                          |   |     enable seamless        |
|             |                          |   |     communication among    |
|             |                          |   |     clinician's offices,   |
|             |                          |   |     laboratories,          |
|             |                          |   |     hospitals, and other   |
|             |                          |   |     health care settings.  |
|             |                          |   |                            |
|             |                          |   | -   Providers actively     |
|             |                          |   |     engage in interactive  |
|             |                          |   |     exchange (web-based or |
|             |                          |   |     other messaging tools) |
|             |                          |   |     of information with    |
|             |                          |   |     patients and other     |
|             |                          |   |     health care providers  |
|             |                          |   |     to provide more        |
|             |                          |   |     thorough understanding |
|             |                          |   |     of health care         |
|             |                          |   |     prevention and         |
|             |                          |   |     treatment options.     |
|             |                          |   |                            |
|             |                          |   | -   All phenotype          |
|             |                          |   |     (clinical              |
|             |                          |   |     descriptors),          |
|             |                          |   |     genotype, and          |
|             |                          |   |     environmental factors  |
|             |                          |   |     will be integrated     |
|             |                          |   |     into an EHR            |
|             |                          |   |                            |
|             |                          |   | -   Providers can use      |
|             |                          |   |     computer assisted      |
|             |                          |   |     programs that provide  |
|             |                          |   |     clinical decision      |
|             |                          |   |     support which provides |
|             |                          |   |     options concerning     |
|             |                          |   |     possible management    |
|             |                          |   |     strategies (i.e.,      |
|             |                          |   |     which drugs to use,    |
|             |                          |   |     and likely outcomes of |
|             |                          |   |     use).                  |
|             |                          |   |                            |
|             |                          |   | -   Value of primary care  |
|             |                          |   |     and the importance of  |
|             |                          |   |     CDS are understood as  |
|             |                          |   |     fundamental to the     |
|             |                          |   |     future of PHC          |
|             |                          |   |                            |
|             |                          |   | -   Analysis tools are     |
|             |                          |   |     available with updated |
|             |                          |   |     algorithms; feedback   |
|             |                          |   |     loops to update data   |
|             |                          |   |     and algorithms         |
|             |                          |   |                            |
|             |                          |   | -   Balance between the    |
|             |                          |   |     science and the art of |
|             |                          |   |     medicine (human        |
|             |                          |   |     inputs) is achieved    |
|             |                          |   |                            |
|             |                          |   | ```{=html}                 |
|             |                          |   | <!-- -->                   |
|             |                          |   | ```                        |
|             |                          |   | -   Follow-up              |
|             |                          |   |     counseling/care        |
|             |                          |   |     accompanies results;   |
|             |                          |   |     providers act as       |
|             |                          |   |     counselors, avoiding   |
|             |                          |   |     paternalistic aspect   |
|             |                          |   |                            |
|             |                          |   | -   Centralized knowledge  |
|             |                          |   |     repository is separate |
|             |                          |   |     from individual        |
|             |                          |   |     patient records        |
|             |                          |   |     database               |
|             |                          |   |                            |
|             |                          |   | ```{=html}                 |
|             |                          |   | <!-- -->                   |
|             |                          |   | ```                        |
|             |                          |   | -   The paradigm of        |
|             |                          |   |     medical education is   |
|             |                          |   |     changed to reflect PHC |
|             |                          |   |     delivered at point of  |
|             |                          |   |     care                   |
+-------------+--------------------------+---+----------------------------+
| **Defining  |                          |   |                            |
| Attributes  |                          |   |                            |
| of PHC with |                          |   |                            |
| Respect to  |                          |   |                            |
| the         |                          |   |                            |
| Provider**  |                          |   |                            |
+-------------+--------------------------+---+----------------------------+
| Genetic     | -   Currently over 1000  |   | -   Full sequence          |
| Tests       |     genetic tests are    |   |     information will       |
|             |     available for a      |   |     negate the use of      |
|             |     variety of diseases. |   |     individual genetic     |
|             |                          |   |     tests. Research and    |
|             | -   Determining the      |   |     development will be on |
|             |     clinical validity of |   |     developing the         |
|             |     genetic tests lacks  |   |     analytic tools and     |
|             |     a widely accepted    |   |     algorithms to derive   |
|             |     process for vetting  |   |     knowledge from the     |
|             |     and disseminating    |   |     sequence information   |
|             |     this information.    |   |                            |
|             |     Clinical validation  |   | -   Genetic testing        |
|             |     of the utility of    |   |     information, from the  |
|             |     genetic tests lacks  |   |     basic science, to the  |
|             |     a systematic         |   |     test and the           |
|             |     approach.            |   |     associated lab data,   |
|             |                          |   |     and finally to the     |
|             | -   Appropriate          |   |     relevant clinical      |
|             |     selection of genetic |   |     findings, are          |
|             |     tests by the         |   |     standardized and       |
|             |     provider is hindered |   |     seamlessly integrated  |
|             |     lack of education    |   |     in the EHR.            |
|             |     and information.     |   |                            |
|             |                          |   | ```{=html}                 |
|             |                          |   | <!-- -->                   |
|             |                          |   | ```                        |
|             |                          |   | -   New genomic tests are  |
|             |                          |   |     validated for analytic |
|             |                          |   |     and clinical validity  |
|             |                          |   |     and practice           |
|             |                          |   |     guidelines are         |
|             |                          |   |     continually updated    |
|             |                          |   |     based on the most      |
|             |                          |   |     recent scientific      |
|             |                          |   |     evidence.              |
|             |                          |   |                            |
|             |                          |   | -   Evidence based genetic |
|             |                          |   |     testing                |
|             |                          |   |                            |
|             |                          |   |     -   agreement on goals |
|             |                          |   |         of service         |
|             |                          |   |                            |
|             |                          |   |     -   generate and       |
|             |                          |   |         synthesize         |
|             |                          |   |         relevant primary   |
|             |                          |   |         empirical evidence |
|             |                          |   |                            |
|             |                          |   |     -   support capacity   |
|             |                          |   |         and understanding  |
|             |                          |   |         of users of        |
|             |                          |   |         evidence           |
|             |                          |   |                            |
|             |                          |   |     -   promote effective  |
|             |                          |   |         implementation of  |
|             |                          |   |         evidence           |
|             |                          |   |                            |
|             |                          |   | ```{=html}                 |
|             |                          |   | <!-- -->                   |
|             |                          |   | ```                        |
|             |                          |   | -   Providers are          |
|             |                          |   |     appropriately trained  |
|             |                          |   |     in clinical genetics,  |
|             |                          |   |     particularly with a    |
|             |                          |   |     shift in genetic       |
|             |                          |   |     information from       |
|             |                          |   |     specialty to primary   |
|             |                          |   |     care and recognition   |
|             |                          |   |     of time constraints of |
|             |                          |   |     clinical encounters    |
+-------------+--------------------------+---+----------------------------+
| Eviden      | -   Some clinical        |   | -   Clinical messages are  |
| ce/Outcomes |     support tools exist  |   |     ranked to maximize use |
|             |     now and a few        |   |     of physician's time,   |
| Clinical    |     include genetic      |   |     by relaying only those |
| Decision    |     variables in risk    |   |     that have the largest  |
| Support     |     factor assessment.   |   |     impact to customize    |
| Systems     |                          |   |     patient encounters     |
|             | -   Development of       |   |                            |
|             |     algorithms to        |   | -   Clinicians trust the   |
|             |     support CDS is slow  |   |     usefulness and         |
|             |     and hindered by lack |   |     accuracy of            |
|             |     of large             |   |     messages/reminders     |
|             |     standardized         |   |                            |
|             |     knowledge            |   | -   Measures and CDS are   |
|             |     repositories from    |   |     routinely enhanced and |
|             |     which to draw        |   |     refined by examining   |
|             |     conclusions and      |   |     'exceptions'.          |
|             |     develop evidence     |   |                            |
|             |                          |   | -   Evidence-based         |
|             | -   Integration into EHR |   |     medicine is practiced  |
|             |     of CDS systems that  |   |     with inputs regarding  |
|             |     add significant      |   |     feasibility, values,   |
|             |     value is slow        |   |     resources, and         |
|             |                          |   |     preferences            |
|             |                          |   |                            |
|             |                          |   | -   Providers have         |
|             |                          |   |     developed competencies |
|             |                          |   |     in understanding       |
|             |                          |   |     probability and        |
|             |                          |   |     confidence in          |
|             |                          |   |     information            |
|             |                          |   |                            |
|             |                          |   | -   Surveillance           |
|             |                          |   |     algorithms are         |
|             |                          |   |     available with         |
|             |                          |   |     information regarding  |
|             |                          |   |     when data was modified |
|             |                          |   |     and by whom            |
|             |                          |   |                            |
|             |                          |   | -   Regional adjustments   |
|             |                          |   |     are made to treatment  |
|             |                          |   |     guidelines for         |
|             |                          |   |     differing populations  |
|             |                          |   |                            |
|             |                          |   | -   CDS systems are        |
|             |                          |   |     incorporated into the  |
|             |                          |   |     EHR and support the    |
|             |                          |   |     clinician and patient  |
|             |                          |   |     in making healthcare   |
|             |                          |   |     decisions.             |
|             |                          |   |                            |
|             |                          |   | -   Patient outcomes are   |
|             |                          |   |     observed in real time  |
|             |                          |   |     based on the use of    |
|             |                          |   |     CDS                    |
|             |                          |   |                            |
|             |                          |   | -   Standard,              |
|             |                          |   |     user-friendly          |
|             |                          |   |     interfaces are         |
|             |                          |   |     available and fully    |
|             |                          |   |     interoperable          |
+-------------+--------------------------+---+----------------------------+
| **Health    |                          |   |                            |
| Information |                          |   |                            |
| Exchange    |                          |   |                            |
| (HIE) and   |                          |   |                            |
| Data Bank   |                          |   |                            |
| Issues**    |                          |   |                            |
+-------------+--------------------------+---+----------------------------+
| Consumer    | *Family History Tools*   |   | -   Patient is engaged in  |
|             |                          |   |     health care, partly    |
|             | *Government              |   |     through input of       |
|             | Initiatives:*            |   |     family history into    |
|             |                          |   |     PHR                    |
|             | -   NLM: Genetics Home   |   |                            |
|             |     Reference, Family    |   | -   Family History tools   |
|             |     History Spotlight    |   |     are standardized for   |
|             |                          |   |     exchange of            |
|             | -   Office of the        |   |     information between    |
|             |     Surgeon General: My  |   |     systmes                |
|             |     Family Heath         |   |                            |
|             |     Portrait             |   | -   Family History tools,  |
|             |                          |   |     in combination with    |
|             | -   CDC: Family          |   |     personal health        |
|             |     Healthware           |   |     history captured in    |
|             |                          |   |     the PHR, can be used   |
|             | -   DoD: Armed Forces    |   |     to create health care  |
|             |     Health Longitudinal  |   |     messages based on      |
|             |     Technology           |   |     validated risk         |
|             |     Application (AHLTA)  |   |     analysis algorithms    |
|             |                          |   |                            |
|             | *Privately Developed     |   |                            |
|             | Tools:*                  |   |                            |
|             |                          |   |                            |
|             | -   The Ohio State       |   |                            |
|             |     University           |   |                            |
|             |     Comprehensive Cancer |   |                            |
|             |     Center, and Multi    |   |                            |
|             |     Media Design, Center |   |                            |
|             |     for Knowledge        |   |                            |
|             |     Development, College |   |                            |
|             |     of Medicine Public   |   |                            |
|             |     Health (*James*Link) |   |                            |
|             |                          |   |                            |
|             | -   Center for Medical   |   |                            |
|             |     Genetics, Evanston   |   |                            |
|             |     Northwestern         |   |                            |
|             |     Healthcare:          |   |                            |
|             |     MyGenerations        |   |                            |
|             |                          |   |                            |
|             | -   UT Southewestern:    |   |                            |
|             |     CancerGene           |   |                            |
|             |                          |   |                            |
|             | *Personal Health Record  |   |                            |
|             | Examples:*               |   |                            |
|             |                          |   |                            |
|             | -   VA: My HealtheVet    |   |                            |
|             |     (MHV)                |   |                            |
|             |                          |   |                            |
|             | -   Continuity of Care   |   |                            |
|             |     Record (CCR)         |   |                            |
+-------------+--------------------------+---+----------------------------+
| Provider    | -   Pilot projects are   |   | -   Standards and          |
|             |     being initiated that |   |     automation exist for   |
|             |     enable clinical      |   |     data entry with red    |
|             |     genetic test         |   |     flags that appear to   |
|             |     information to be    |   |     connect to research    |
|             |     exchanged            |   |     findings and clinical  |
|             |                          |   |     protocols,             |
|             | *Genetic Test            |   |     interpretations of     |
|             | Resources:*              |   |     tests, utility, and    |
|             |                          |   |     knowledge management   |
|             | -   Genetics Home        |   |     guidance               |
|             |     Reference            |   |                            |
|             |                          |   | -   Quality measures allow |
|             | -   GeneTests            |   |     providers to compare   |
|             |                          |   |     experiences with other |
|             |                          |   |     providers              |
|             |                          |   |                            |
|             |                          |   | -   Providers have ready   |
|             |                          |   |     access to accurate and |
|             |                          |   |     quality information,   |
|             |                          |   |     including guidelines,  |
|             |                          |   |     drug labels and        |
|             |                          |   |     treatment protocols,   |
|             |                          |   |     that is stored         |
|             |                          |   |     usefully to prevent    |
|             |                          |   |     duplication (avoidance |
|             |                          |   |     of waste) and is       |
|             |                          |   |     updated in a timely    |
|             |                          |   |     manner                 |
|             |                          |   |                            |
|             |                          |   | -   Providers have direct  |
|             |                          |   |     access to and          |
|             |                          |   |     communication with     |
|             |                          |   |     other providers and    |
|             |                          |   |     are alerted to         |
|             |                          |   |     appropriate protocols  |
|             |                          |   |                            |
|             |                          |   | -   Research enterprise is |
|             |                          |   |     integrated into        |
|             |                          |   |     information management |
|             |                          |   |     systems to supply      |
|             |                          |   |     knowledge and          |
|             |                          |   |     resources. Relevant    |
|             |                          |   |     agencies (i.e., NIH,   |
|             |                          |   |     National Library of    |
|             |                          |   |     Medicine, FDA, etc.)   |
|             |                          |   |     can link updated       |
|             |                          |   |     information to the     |
|             |                          |   |     record system.         |
|             |                          |   |     Additionally, links to |
|             |                          |   |     population health      |
|             |                          |   |     surveillance systems   |
|             |                          |   |     are available.         |
+-------------+--------------------------+---+----------------------------+
| Electronic  | -   Electronic exchange  |   | -   Bi-directional         |
| co          |     of information       |   |     exchange of            |
| mmunication |     between consumer and |   |     information            |
| between     |     provider nearly      |   |                            |
| consumer    |     nonexistent          |   | -   The PHR are separate   |
| and         |                          |   |     but fully              |
| provider    |                          |   |     interoperable with the |
|             |                          |   |     EHR with accompanying  |
|             |                          |   |     clinical decision      |
|             |                          |   |     support                |
|             |                          |   |                            |
|             |                          |   | -   Common vocabulary is   |
|             |                          |   |     used across            |
|             |                          |   |     technologies           |
|             |                          |   |                            |
|             |                          |   | -   Informed consent       |
|             |                          |   |                            |
|             |                          |   | -   Knowledge management:  |
|             |                          |   |     patients manage access |
|             |                          |   |     to health information  |
|             |                          |   |                            |
|             |                          |   | -   Ownership of patient   |
|             |                          |   |     information clarified  |
|             |                          |   |                            |
|             |                          |   | -   Role-based control and |
|             |                          |   |     audit trails so        |
|             |                          |   |     consumers can see who  |
|             |                          |   |     has accessed their     |
|             |                          |   |     health information     |
|             |                          |   |                            |
|             |                          |   | -   Partnership exists     |
|             |                          |   |     between consumers and  |
|             |                          |   |     providers with secure, |
|             |                          |   |     interoperable exchange |
|             |                          |   |     of information         |
|             |                          |   |                            |
|             |                          |   | -   EHRs have been         |
|             |                          |   |     constructed such that  |
|             |                          |   |     they are upgradeable   |
|             |                          |   |     to the next generation |
|             |                          |   |     of HIT                 |
+-------------+--------------------------+---+----------------------------+
| Technical   | *Basic Science*          |   | -   Where harmonization is |
| Standards   |                          |   |     possible is            |
| for         | -   Human Gene           |   |     identified, where it   |
| Clinical    |     Nomenclature (HUGN)  |   |     is not possible is     |
| Information |                          |   |     clearly defined, and   |
|             | -   Online Mendelian     |   |     systems that allow for |
|             |     Inheritance in Man   |   |     variation are          |
|             |     (OMIM)               |   |     developed              |
|             |                          |   |                            |
|             | *Accompanying lab test   |   | -   Standards are used in  |
|             | information*             |   |     the development of a   |
|             |                          |   |     wide variety of PHR    |
|             | -   MicroArray and Gene  |   |     and EHRs so that       |
|             |     Expression Markup    |   |     medical genomic        |
|             |     Language (MAGE-ML)   |   |     information and family |
|             |                          |   |     history information    |
|             | -   Bioinformatic        |   |     are usefully           |
|             |     Sequence Markup      |   |     incorporated in these  |
|             |     Language (BSML)      |   |     electronic tools that  |
|             |                          |   |     are available and used |
|             | -   Logical Observation  |   |     by the vast majority   |
|             |     Identifiers Names    |   |     of patients and        |
|             |     and Codes (LOINC)    |   |     clinicians.            |
|             |                          |   |                            |
|             | -   Clinical             |   |                            |
|             |     Bioinformatics       |   |                            |
|             |     Ontology (CBO)       |   |                            |
|             |                          |   |                            |
|             | *Clinically relevant     |   |                            |
|             | findings*                |   |                            |
|             |                          |   |                            |
|             | -   Systemized           |   |                            |
|             |     Nomenclature of      |   |                            |
|             |     Medicine Clinical    |   |                            |
|             |     Terminology (SNOMED  |   |                            |
|             |     CT)                  |   |                            |
|             |                          |   |                            |
|             | -   Unified Medical      |   |                            |
|             |     Language Thesaurus   |   |                            |
|             |     (as listed at NLM)   |   |                            |
+-------------+--------------------------+---+----------------------------+
| Inter       | *Standards*              |   | -   Continuity of          |
| operability |                          |   |     standards between      |
| of EHRs,    | -   Health Level Seven   |   |     technology, diagnostic |
| PHRs, and   |     (HL7)                |   |     test, patient health   |
| Labs        |                          |   |     record, information    |
|             | -   Clinical Data        |   |     warehouses             |
|             |     Interchange          |   |                            |
|             |     Standards Consortium |   | -   Standards are used in  |
|             |     (CDISC)              |   |     the development of     |
|             |                          |   |     interoperable          |
|             | -   Continuity of Care   |   |     communications between |
|             |     Record (CCR)         |   |     PHR, EHR, and          |
|             |                          |   |     laboratories.          |
|             | -   EHR-Lab              |   |                            |
|             |     Interoperability and |   | -   All information        |
|             |     Connectivity         |   |     captured in the        |
|             |     Standards (ELINCS)   |   |     laboratory test,       |
|             |                          |   |     including data         |
|             |                          |   |     standards, controls,   |
|             |                          |   |     methods, full sequence |
|             |                          |   |     information, etc., are |
|             |                          |   |     included in the EHR    |
|             |                          |   |     for potential future   |
|             |                          |   |     use                    |
|             |                          |   |                            |
|             |                          |   | -   Only the clinically    |
|             |                          |   |     relevant information   |
|             |                          |   |     is displayed to the    |
|             |                          |   |     clinician and the      |
|             |                          |   |     patient to make        |
|             |                          |   |     maximum use of the     |
|             |                          |   |     knowledge with the     |
|             |                          |   |     minimum display of     |
|             |                          |   |     data.                  |
+-------------+--------------------------+---+----------------------------+
| Confi       | -   GINA passed in       |   | -   Genetic                |
| dentiality, |     Senate focused on    |   |     non-discrimination     |
| Privacy and |     non-discrimination   |   |     complete               |
| Security    |                          |   |                            |
| (CPS)       | -   HIPAA provides       |   | -   Risk associated with   |
|             |     baseline protections |   |     certain types of       |
|             |                          |   |     genetic information    |
|             |                          |   |     will be understood     |
|             |                          |   |                            |
|             |                          |   | -   Genetic privacy        |
|             |                          |   |                            |
|             |                          |   | -   Secondary use of       |
|             |                          |   |     genetic information    |
|             |                          |   |     (look at quality       |
|             |                          |   |     matrix for description |
|             |                          |   |     of end state of        |
|             |                          |   |     appropriate secondary  |
|             |                          |   |     uses)                  |
|             |                          |   |                            |
|             |                          |   | -   Security of health and |
|             |                          |   |     genetic information    |
|             |                          |   |                            |
|             |                          |   | -   Ownership of patient   |
|             |                          |   |     information clarified  |
|             |                          |   |                            |
|             |                          |   | -   Consent is better      |
|             |                          |   |     informed through       |
|             |                          |   |     education of the       |
|             |                          |   |     consumer               |
+-------------+--------------------------+---+----------------------------+
| **          |                          |   |                            |
| Description |                          |   |                            |
| of Other    |                          |   |                            |
| St          |                          |   |                            |
| akeholders' |                          |   |                            |
| Experiences |                          |   |                            |
| with        |                          |   |                            |
| P           |                          |   |                            |
| ersonalized |                          |   |                            |
| Health      |                          |   |                            |
| Care**      |                          |   |                            |
+-------------+--------------------------+---+----------------------------+
| **R&D /     | -   The sequence of the  |   | -   For many diseases, a   |
| HIT**       |     human genome,        |   |     plethora of new        |
|             |     combined with the    |   |     genetic markers of     |
| -           |     power of genomic     |   |     major chronic diseases |
| Researchers |     analysis techniques, |   |     will be discovered as  |
|             |     such as the HapMap,  |   |     a consequence of       |
| -           |     SNP analysis and     |   |     genome wide            |
|    Research |     GWAS, are rapidly    |   |     association studies    |
|             |     advancing the basic  |   |     and other programs     |
|    subjects |     understanding of     |   |     that link genotype     |
|             |     disease processes.   |   |     with phenotype.        |
| -   Public  |                          |   |                            |
|     health  | -   Translation of this  |   | -   The evolution of genes |
|             |     knowledge into       |   |     and environment        |
| -           |     clinically useful    |   |     databases provides     |
|    Industry |     knowledge and        |   |     context to risk        |
|             |     effective            |   |     management for certain |
| -   Labs    |     interventions and    |   |     chronic diseases at a  |
|             |     therapies largely    |   |     population level.      |
| -   EHR     |     still remains to be  |   |                            |
|     vendors |     realized.            |   | -   New opportunities for  |
|             |                          |   |     innovative strategies  |
|             | *Translation of Basic    |   |     in prevention and      |
|             | Research*                |   |     preemption emerge from |
|             |                          |   |     better understanding   |
|             | *NIH Programs:*          |   |     of genetic and         |
|             |                          |   |     environmental factors  |
|             | -   Genome Wide          |   |     that contribute to     |
|             |     Association Studies  |   |     disease.               |
|             |     (GWAS)               |   |                            |
|             |                          |   | -   Many aspects of health |
|             | -   Cancer               |   |     disparities or         |
|             |     BioInformatics Grid  |   |     differences in disease |
|             |     (CaBIG)              |   |     outcomes are explained |
|             |                          |   |     and lessened as a      |
|             | -   Database of Genotype |   |     consequence of         |
|             |     and Phenotype        |   |     understanding genetic  |
|             |     (dbGAP)              |   |     and environmental      |
|             |                          |   |     contributors.          |
|             | -   The Cancer Genome    |   |                            |
|             |     Atlas (TCGA)         |   | -   Researchers operate in |
|             |                          |   |     accordance with        |
|             | -   The Biomarkers       |   |     principles of          |
|             |     Consortium,          |   |     community-based        |
|             |                          |   |     participatory          |
|             | -   The Pharmacogenomics |   |     research, partnership  |
|             |     Research Network     |   |     with consumers and     |
|             |     (PGRN)               |   |     users                  |
|             |                          |   |                            |
|             | The Genes and            |   | -   Balance between        |
|             | Environment Initiative   |   |     traditional research   |
|             | (GEI)                    |   |     and real-time data     |
|             |                          |   |     capture                |
|             | -   Public health        |   |                            |
|             |     researchers have     |   | -   Large clinical genomic |
|             |     limited access to    |   |     databases for several  |
|             |     large datasets of    |   |     major chronic diseases |
|             |     patient information. |   |     will be developed with |
|             |                          |   |     descriptions of        |
|             | *Public Health           |   |     clinical outcomes.     |
|             | Evaluation*              |   |                            |
|             |                          |   | -   Health maintenance     |
|             | *CDC Programs:*          |   |     organizations, payers  |
|             |                          |   |     and employers will     |
|             | -   Evaluation of        |   |     encourage use of       |
|             |     Genomic Applications |   |     personalized health    |
|             |     in Practice and      |   |     records to facilitate  |
|             |     Prevention (EGAPP)   |   |     an individual's health |
|             |                          |   |     care.                  |
|             | -   ACCE, which takes    |   |                            |
|             |     its name from the    |   | -   Common approaches to   |
|             |     four components of   |   |     developing new         |
|             |                          |   |     therapies include use  |
|             |    evaluation---analytic |   |     of genetically-based   |
|             |     validity, clinical   |   |     biomarkers to          |
|             |     validity, clinical   |   |     accelerate discovery   |
|             |     utility and          |   |     and development of     |
|             |     associated ethical,  |   |     medical products.      |
|             |     legal and social     |   |                            |
|             |     implications         |   | -   Data from              |
|             |                          |   |     interoperable EHRs is  |
|             | -   Human Genome         |   |     available to the       |
|             |     Epidemiology         |   |     research enterprise to |
|             |     Network, (HuGENet™)  |   |     better assess and      |
|             |                          |   |     prioritize national    |
|             | -   Clinical validation  |   |     quality metrics and    |
|             |     of the utility of    |   |     guidelines             |
|             |     genetic tests lacks  |   |                            |
|             |     a systematic         |   | -   Focus moves from       |
|             |     approach.            |   |     collecting large banks |
|             |                          |   |     of information to      |
|             | -   Post-marketting      |   |     perform research, but  |
|             |     surveillance of      |   |     to analyzing the rich  |
|             |     diagnostics and      |   |     wealth of data         |
|             |     therapeutics is      |   |     available through      |
|             |     underutilized        |   |     electronic             |
|             |                          |   |     databases/warehouses   |
|             | -   Rx and coresponding  |   |                            |
|             |     Dx are rarely        |   | -   Basic research is      |
|             |     codeveloped          |   |     rapidly translated     |
|             |                          |   |     from the bench to the  |
|             | -   The underlying       |   |     bedside leading to:    |
|             |     genetic factors for  |   |     more effective,        |
|             |     adverse reactions to |   |     targeted therapies;    |
|             |     therapeutics is just |   |     the use of genomic     |
|             |     beginning to be      |   |     tests to monitor drug  |
|             |     investigated         |   |     therapy; widespread    |
|             |                          |   |     availability of        |
|             | -   Regulatory oversight |   |     medical tests to       |
|             |     structure of         |   |     identify disease       |
|             |     diagnostics is       |   |     predispositions early  |
|             |     fragmented and not   |   |     and enabling           |
|             |     well developed       |   |     preemptive and         |
|             |                          |   |     preventive measures to |
|             |                          |   |     be undertaken.         |
|             |                          |   |                            |
|             |                          |   | -   An integrated system   |
|             |                          |   |     of health information  |
|             |                          |   |     (network of networks)  |
|             |                          |   |     from different health  |
|             |                          |   |     care delivery systems  |
|             |                          |   |     exists. Collaborations |
|             |                          |   |     among payer and        |
|             |                          |   |     publicly provided      |
|             |                          |   |     health care networks   |
|             |                          |   |     develop policies that  |
|             |                          |   |     facilitate information |
|             |                          |   |     exchange to support    |
|             |                          |   |     evidence-development,  |
|             |                          |   |     safety assessment, and |
|             |                          |   |     outcomes research.     |
|             |                          |   |                            |
|             |                          |   | -   Research in public     |
|             |                          |   |     health is aided by the |
|             |                          |   |     immense amount of data |
|             |                          |   |     accumulated in health  |
|             |                          |   |     care delivery, as it   |
|             |                          |   |     is organized in ways   |
|             |                          |   |     that can be used to    |
|             |                          |   |     improve the quality    |
|             |                          |   |     and efficiency of      |
|             |                          |   |     health care at an      |
|             |                          |   |     individual level.      |
|             |                          |   |                            |
|             |                          |   | -   Information is useful  |
|             |                          |   |     and accessible         |
|             |                          |   |                            |
|             |                          |   | -   Value of information   |
|             |                          |   |     banks is realized      |
|             |                          |   |                            |
|             |                          |   | -   Use of biospecimens is |
|             |                          |   |     regulated with fully   |
|             |                          |   |     informed consent and   |
|             |                          |   |     data ownership is      |
|             |                          |   |     understood             |
|             |                          |   |                            |
|             |                          |   | -   Value of de-identified |
|             |                          |   |     data in standard       |
|             |                          |   |     format widely          |
|             |                          |   |     available              |
|             |                          |   |                            |
|             |                          |   | ```{=html}                 |
|             |                          |   | <!-- -->                   |
|             |                          |   | ```                        |
|             |                          |   | -   Many clinical          |
|             |                          |   |     development programs   |
|             |                          |   |     for new therapies      |
|             |                          |   |     focus on individual    |
|             |                          |   |     differences in         |
|             |                          |   |     patients that have a   |
|             |                          |   |     genetic basis.         |
|             |                          |   |                            |
|             |                          |   |     -   Engage             |
|             |                          |   |         pharmaceutical and |
|             |                          |   |         diagnostics        |
|             |                          |   |         industries to      |
|             |                          |   |         partner to develop |
|             |                          |   |         Rx/Dx combinations |
|             |                          |   |                            |
|             |                          |   | ```{=html}                 |
|             |                          |   | <!-- -->                   |
|             |                          |   | ```                        |
|             |                          |   | -   Diagnostics developers |
|             |                          |   |     play a role            |
|             |                          |   |     introducing academics  |
|             |                          |   |     to pharmaceutical      |
|             |                          |   |     developers,            |
|             |                          |   |     diagnostics developers |
|             |                          |   |     partner with basic     |
|             |                          |   |     researchers to         |
|             |                          |   |     identify new           |
|             |                          |   |     targetsNetworks of     |
|             |                          |   |     networks emerge as new |
|             |                          |   |     approaches to product  |
|             |                          |   |     evaluation. More       |
|             |                          |   |     information is         |
|             |                          |   |     obtained *after*       |
|             |                          |   |     market approval than   |
|             |                          |   |     prior enabling better  |
|             |                          |   |     use of information     |
|             |                          |   |     from clinical outcomes |
|             |                          |   |     evaluations.           |
|             |                          |   |                            |
|             |                          |   | -   The majority of        |
|             |                          |   |     mortality of adverse   |
|             |                          |   |     events due to drugs    |
|             |                          |   |     and vaccines are       |
|             |                          |   |     avoided as a           |
|             |                          |   |     consequence of         |
|             |                          |   |     understanding genetic  |
|             |                          |   |     predisposition and     |
|             |                          |   |     selecting the best     |
|             |                          |   |     interventions for each |
|             |                          |   |     patient.               |
|             |                          |   |                            |
|             |                          |   | -   Cross-sector           |
|             |                          |   |     collaborations in      |
|             |                          |   |     health information     |
|             |                          |   |     technology,            |
|             |                          |   |     diagnostics, and       |
|             |                          |   |     pharmaceutical         |
|             |                          |   |     industries will emerge |
|             |                          |   |     in new partnerships.   |
|             |                          |   |                            |
|             |                          |   | -   Publicly available     |
|             |                          |   |     genomic databases      |
|             |                          |   |     serve to support a     |
|             |                          |   |     majority of drug       |
|             |                          |   |     discovery efforts.     |
|             |                          |   |                            |
|             |                          |   | ```{=html}                 |
|             |                          |   | <!-- -->                   |
|             |                          |   | ```                        |
|             |                          |   | -   Regulatory clarity     |
|             |                          |   |     exists and innovation  |
|             |                          |   |     is rewarded            |
|             |                          |   |                            |
|             |                          |   | -   Commercialization of   |
|             |                          |   |     clinical trial data    |
|             |                          |   |     with associated        |
|             |                          |   |     risks/benefits         |
|             |                          |   |                            |
|             |                          |   | -   Process is transparent |
|             |                          |   |                            |
|             |                          |   | -   Post-marketing         |
|             |                          |   |     surveillance is        |
|             |                          |   |     ongoing                |
|             |                          |   |                            |
|             |                          |   | -   Quality of care is     |
|             |                          |   |     improved and measured; |
|             |                          |   |     data are used for      |
|             |                          |   |     continuous quality     |
|             |                          |   |     improvement research   |
|             |                          |   |                            |
|             |                          |   | -   Point-of-care learning |
|             |                          |   |     and CDS are            |
|             |                          |   |     established for        |
|             |                          |   |     providers              |
|             |                          |   |                            |
|             |                          |   | -   Well-defined           |
|             |                          |   |     mechanisms and         |
|             |                          |   |     protocols are in place |
|             |                          |   |     to evaluate data       |
|             |                          |   |     quality and quality    |
|             |                          |   |     control                |
+-------------+--------------------------+---+----------------------------+

+-----------------------+-----------------------------------------------+
| Other Stakeholders    |                                               |
+-----------------------+-----------------------------------------------+
| **Payer**             | -   Payers                                    |
|                       |                                               |
|                       | -   Employers                                 |
|                       |                                               |
|                       | -   Insurers                                  |
|                       |                                               |
|                       | -   Government (i.e., CMS, VA, DoD, etc.)     |
+-----------------------+-----------------------------------------------+
| **Advocacy**          | -   Support groups                            |
|                       |                                               |
|                       | -   Family                                    |
|                       |                                               |
|                       | -   Community                                 |
|                       |                                               |
|                       | -   Educators                                 |
|                       |                                               |
|                       | -   Racial and ethnic groups                  |
+-----------------------+-----------------------------------------------+
| **Policy**            | -   Regulatory agencies                       |
|                       |                                               |
|                       | -   Legislation                               |
+-----------------------+-----------------------------------------------+
| **Secondary Uses**    | -   Law enforcement                           |
|                       |                                               |
|                       | -   Direct-to-consumer marketing              |
+-----------------------+-----------------------------------------------+

  -------------------------------------------- ----------- -------------- ------------ -------------
  Description of Other Stakeholders'                                                   
  Experiences with Personalized Health Care                                            

  **End State**                                **Payer**   **Advocacy**   **Policy**   **Secondary
                                                                                       Uses**

  Information is useful and accessible                                              

  Value of information banks is realized                                            

  Regulatory clarity exists and innovation is                                       
  rewarded                                                                             

  Commercialization of clinical trial data                                          
  with associated risks/benefits                                                       

  Process is transparent                                                            

  Patient fear is prevented from impeding                                           
  consumer-provider relationship                                                       

  Quality of care is improved and measured;                                         
  data are used for continuous quality                                                 
  improvement research                                                                 

  Use of biospecimens is regulated with fully                                        
  informed consent and data ownership is                                               
  understood                                                                           

  For secondary uses, disclosure is limited to                                       
  relevant information only; distinguish                                               
  between no intent to identify the individual                                         
  (hypotheses generation) vs. intent to                                                
  identify the individual                                                              

  Well-defined mechanisms and protocols are in                                        
  place to evaluate data quality and quality                                           
  control                                                                              

  Post-marketing surveillance is ongoing                                              

  Clear rules, codes of conduct and tools for                                        
  enforcement exist                                                                    

  Analysis tools are available with updated                                           
  algorithms; feedback loops to update data                                            
  and algorithms                                                                       

  Value of de-identified data in standard                                             
  format widely available                                                              

  Bi-directional exchange of information                                             

  Researchers operate in accordance with                                              
  principles of community-based participatory                                          
  research; partnership with consumers and                                             
  users                                                                                

  Balance between traditional research and                                            
  real-time data capture                                                               
  -------------------------------------------- ----------- -------------- ------------ -------------

**Enablers and Barriers**

**Enablers:**

-   Raise awareness and participation in the entire process with all
    stakeholders

-   Engage discussion to assess progress with stakeholders (advocacy,
    professional development, research and development) to ensure
    widespread ownership of the whole enterprise

1.  Evidence development and translation into a computable clinical
    environment

    a.  **Barrier**: Limited evidence and few clinical practice
        guidelines and measures specific to appropriate use of genetic
        information

    b.  **Enabler**: Build on case studies or therapeutic areas where
        sufficient evidence exists to develop and pilot CDS
        infrastructure and EHRs to demonstrate value

    c.  **Barrier**: No infrastructure or incentives to use computable
        electronic guidelines or measures

2.  Usable system to ensure widespread adoption

    a.  **Barriers**: EHR/PHR/RHIO adoption falters; despite widespread
        adoption, still lack ability to capture outcomes in timely
        fashion

    b.  **Enablers**: Standard format for family history to
        systematically perform risk assessment and inform care (by
        2010); identification and adoption of standards, including
        portability of information; demonstration that standards are
        worthwhile; mechanisms to make EHR universally available;
        engagement of the public in the excitement of PHC

3.  Privacy and security issues

    a.  **Barrier**: Harm patients because of fears of hypothetical
        threats

    b.  **Enablers**: Understand risk associated with certain types of
        genetic information (in five years); from 6/22/06 NCVHS
        recommendations: 1) Contextual access criteria limits to
        necessary information; 2) Ensure privacy and confidentiality
        rules apply to all collection/exchange of health information; 3)
        Reduce harm of discriminatory use of health information; 4)
        Research to assess CPS of NHIN and consumer confidence

4.  Effective knowledge management systems

    a.  **Barrier**: Lack of genetic education/literacy; genetic
        information still too complicated to use; slow updating of
        information for CDS

    b.  **Enablers**: Recognize lack of knowledge and study how to get
        genetic information and deliver in context of care; model for
        CDS is vetted and initialized; demonstrate yield of knowledge
        from de-identified information; improve education; form bonds
        with the Association of American Medical Colleges (AAMC)

5.  Research and development

    a.  **Barriers**: Delay in regulation of rapidly developing
        products; lack of critical mass of relevant clinical data; high
        cost of carrying out many clinical studies; lack of
        incentives/mechanisms for including 'related information' in
        experimental design of clinical studies

    b.  **Enablers**: Research in real-world networks of care; scalable
        methods

6.  Policy

    a.  **Barriers**: Excessive litigation (potential loss of
        community); lack of regulation of RHIOs; lack of reimbursement
        models; cost-effectiveness not demonstrated; reimbursement
        policies that do not reward adoption

    b.  **Enablers**: Appropriate oversight of genetic tests (in five
        years); genetic non-discrimination legislation; incentives for
        public/private partnerships

**Assumptions:**

-   Capabilities currently exist for linking large datasets. Generation
    of large-scale, individual-level genomic data will be feasible with
    protections for and limits on the use of such information in place.

-   Framework for analysis of large, linked datasets will be available

-   Analytical accuracy and clinical validity of genetic tests have a
    multi-stakeholder consensus process for approval

-   Widespread adoption of EHRs, PHRs, and network services for HIE

-   Genetic lab tests with evidence that substantiates
    cost-effectiveness are reimbursed by public and private payers

-   Robust privacy and security exist in law, business operations and
    technology solutions