------------ --------------- --------------- --------------- ---------------
  Attendees:   John Lumpkin    Chip Kahn       Kelly Cronin    Jim Craver

  Ed Sondik    Art Davidson    Shawn Grannis   Steve Solomon   Tom Savel

                                               Shu McGarvey    Laura Conn
  ------------ --------------- --------------- --------------- ---------------

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| **Discussion**                                                       |
+======================================================================+
| **Three areas to consider for organizing thoughts around             |
| recommendations**                                                    |
|                                                                      |
| 1.  Electronic reporting from EHRs, including decision support that  |
|     prompts a physician to initiate an AEs report, and the ability   |
|     to interactively initiate a report from an EHR and have patient  |
|     and other pertinent information pre-populated from the HER.      |
|                                                                      |
| 2.  Ability to use Data Mining for signal detection and to analyze   |
|     patterns in AEs                                                  |
|                                                                      |
| 3.  Facilitate reporting in States where Medical Error reporting is  |
|     mandated by law                                                  |
|                                                                      |
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|                                                                      |
| 2 kinds of reporting exists:                                         |
|                                                                      |
| 1.  Pharmaceutical or device and                                     |
|                                                                      |
| 2.  Medical Error Reporting                                          |
|                                                                      |
| Suggestion that we focus on the 1^st^ while keeping in mind the      |
| needs of the 2^nd^.                                                  |
|                                                                      |
| For Data Mining --                                                   |
|                                                                      |
| -   Need to focus on recommendations that will allow us to get the   |
|     data. Then analysis can be done to determine the appropriate     |
|     criteria to apply, implement the criteria using clinical query   |
|     languages, identify triggers, and then review ADEs that are      |
|     identified, once the data is available. This all relates to      |
|     developing the infrastructure to support making sense of the     |
|     data captured in the repository.                                 |
|                                                                      |
| -   Need definitions for specific ADEs of interest as a first step - |
|     so they can be detected through data analysis.                   |
|                                                                      |
| CPOE (Computerized Physician Order Entry) is another source for      |
| data, may be able to integrate patient reminders at this point.      |
| (there was some discussion of this being out of scope for AEs)       |
|                                                                      |
| Discussed an Organizational Framework for thinking about AE          |
| recommendations. Some areas for recommendations that were suggested  |
| include:                                                             |
|                                                                      |
| 1.  Standards -- for Format and Content. There are existing efforts  |
|     in this area but they are not necessarily standardized           |
|     themselves.                                                      |
|                                                                      |
| 2.  Roles -- need to work with stakeholders to define their roles    |
|     and determine the needs of various stakeholders.                 |
|                                                                      |
| 3.  Authorization and Access Control -- MOUs or policy to support    |
|     sharing of data for ADE detection                                |
|                                                                      |
| 4.  Pilot projects -- proof of concept pilot to understand how to    |
|     apply analysis and do signal detection. What are the methods     |
|     that need to be developed to support this? Pilots can be         |
|     leveraged though RHIOs/HIEs and possible NHIN implementations.   |
|     The same infrastructure should be developed and used for various |
|     types of public health surveillance.                             |
|                                                                      |
| Challenges                                                           |
|                                                                      |
| 1.  Determine the need and then determine what is Health IT related  |
|                                                                      |
| 2.  Hospitals have a hard time participating because they're         |
|     required to report to agencies differently                       |
|                                                                      |
| 3.  Define what we mean by the scope of AE detection and reporting.  |
|     Determine the taxonomy of AEs -- review 2003 IOM report on       |
|     *Patient Safety: Achieving a New Standard for Care*              |
|                                                                      |
| 4.  Access Control -- policy level authorization -- how should this  |
|     be handled to enable sharing of data?                            |
|                                                                      |
| Considerations:                                                      |
|                                                                      |
| -   How to deliver data to PH w/o encumbering the clinician          |
|                                                                      |
| -   How can we all fit together and work together, especially given  |
|     the similarities of some of the efforts?                         |
|                                                                      |
| -   Focus on automated collection -- look at proxy data and          |
|     surrogates to build the value case (linking ICD-9 codes and CPT  |
|     codes)                                                           |
|                                                                      |
| Next steps                                                           |
|                                                                      |
| 1.  Define contextual situations; develop simple use cases -- What   |
|     data is available? How do we use standards? What can we do in    |
|     the future? What data is analyzed?                               |
|                                                                      |
| 2.  Review State legislation to determine the reporting legislation  |
|     in place and categories of reports that are required             |
|                                                                      |
| 3.  Review 2003 IOM report for taxonomy and suggestions for          |
|     recommendations.                                                 |
|                                                                      |
| 4.  Develop a matrix to convey the different categories of AE        |
|     reports                                                          |
|                                                                      |
| 5.  Explore scope of next round of use cases so our recommendations  |
|     can be targeted, and will both get traction and provide the      |
|     biggest "bang for the buck" to PH.                               |
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|                                                                      |
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