Text: SF00153 Text: SF00155 Text: SF00100 - SF00199 Text: SF Index Bills and Amendments: General Index Bill History: General Index
PAG LIN
1 1 Section 1. Section 144C.6, Code 1995, is amended by adding
1 2 the following new subsection:
1 3 NEW SUBSECTION. 2A. The board shall establish policies
1 4 and procedures which provide access to researchers, with the
1 5 approval of the institutional review board of the institution
1 6 with which the researcher is affiliated, to patient-
1 7 identifiable data provided to the system if the institutional
1 8 review board certifies that all of the following conditions
1 9 are met:
1 10 a. Use of the data in personally identifiable form is
1 11 necessary to the research.
1 12 b. The risk of harm to the subject of the data is minimal.
1 13 c. Adequate safeguards are implemented to protect the
1 14 record or information from unauthorized disclosure.
1 15 d. Removal and destruction of identifiers will be carried
1 16 out when the research is complete.
1 17 The board shall also adopt procedures which do not require
1 18 patient authorization under this subsection, but which do
1 19 include notification of patients of the uses that may be made
1 20 of patient records by researchers under this subsection.
1 21 Sec. 2. Section 145.4, Code 1995, is amended by adding the
1 22 following new subsection:
1 23 NEW SUBSECTION. 5. From the health data commission and
1 24 any persons from whom the commission collects data to
1 25 researchers, with the approval of the institutional review
1 26 board of the institution with which the researcher is
1 27 affiliated. Notwithstanding any other provision to the
1 28 contrary, the data provided to a researcher under this
1 29 subsection may be provided in a patient-identifiable manner,
1 30 if the institutional review board certifies that all of the
1 31 following conditions are met:
1 32 a. Use of the data in personally identifiable form is
1 33 necessary to the research.
1 34 b. The risk of harm to the subject of the data is minimal.
1 35 c. Adequate safeguards are implemented to protect the
2 1 record or information from unauthorized disclosure.
2 2 d. Removal and destruction of identifiers will be carried
2 3 out when the research is complete.
2 4 The commission shall adopt procedures which do not require
2 5 patient authorization under this subsection but which do
2 6 require the notification of patients of the uses that may be
2 7 made of patient records and information under this subsection.
2 8 EXPLANATION
2 9 This bill provides for the accessing of data collected by
2 10 the community health management information system under
2 11 chapter 144C or by the health data commission under chapter
2 12 145 by researchers in patient-identifiable form, if the
2 13 patient is notified of the uses that may be made of patient
2 14 records and information, and if the institutional review board
2 15 of the institution with which a researcher is affiliated
2 16 certifies that the data in personally identifiable form is
2 17 necessary to the research, the risk of harm to the subject of
2 18 the data is minimal, adequate safeguards are implemented to
2 19 protect the record or information from unauthorized
2 20 disclosure, and removal and destruction of identifiers will be
2 21 carried out when the research is complete.
2 22 LSB 1662SS 76
2 23 pf/jw/5
Text: SF00153 Text: SF00155 Text: SF00100 - SF00199 Text: SF Index Bills and Amendments: General Index Bill History: General Index
Iowa General Assembly
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