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MEG Users Meeting 4/11/03

MEG Users Meeting 4/11/03. HIPAA Compliance: Acquiring and Saving MEG Data. Main problem. Saving data: main problems. HIPAA methods: Step 1. Each group will now have its own login name and pswd for sinuhe Group names are created as: acqxxxx e.g. megclin, meghalg, megmbar, etc

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MEG Users Meeting 4/11/03

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  1. MEG Users Meeting 4/11/03 HIPAA Compliance: Acquiring and Saving MEG Data

  2. Main problem

  3. Saving data: main problems

  4. HIPAA methods: Step 1 • Each group will now have its own login name and pswd for sinuhe • Group names are created as: acqxxxx • e.g. megclin, meghalg, megmbar, etc • The same group will also be created on the linux side—this group will own your data files

  5. HIPAA methods: Step 2 • Subject Type: • Default is Volunteers, instead select Patients • Registered and MEG data will now be available only to your group

  6. Accessible to group: Change to your lab’s group name, e.g. acqwest HIPAA methods: Step 3

  7. HIPAA methods: Step 4 HIS ID: west001 • HIS ID can be any code of your choosing… • Use unique names • e.g. west001 vs 001 • Directories will now be named as: • /subj_<HIS>/<date>/

  8. HIPAA methods: Step 5 • Data files should be saved with this code as well (rather than initials)

  9. HIPAA methods: Step 6 • In addition to logging out of the Acquisition program, you also need to log off the computer • Simply hit Exit on the task bar at the bottom of any window

  10. PI’s responsibility: To do list http://www.healthcare.partners.org/phsirb/hipaa2do.htm

  11. Approved/ongoing protocols (prior to 4/14) • Subjects enrolled prior to 4/14 • Authorizations not required (unless subject re-consented after 4/14) • Subjects enrolled on or after 4/14 • Subject must sign both a consent form and an authorization form • Must be given a copy of the Privacy Notice, and obtain written acknowledgement of receipt

  12. Authorization form • Downloadable from website • Fulfills specific elements of Privacy Rule without requiring you to rewrite/resubmit existing consent form • Must provide a copy to the Human Research Office to document compliance with the Privacy Rule • Authorization will not be reviewed by the PHRC - you are responsible for the accuracy of the information in the document • Signed Authorization should be kept with signed consent form • Free-standing Authorization should be used until your PHRC-approved consent form includes the authorization language (ie, merge consent with Authorization)

  13. Privacy Notice • Privacy Notice can be downloaded from previously mentioned site, and does not need to be “approved” by Human Research Office • Signed acknowledgement forms must be returned to the Privacy Officer at your institution • Although not required, recommended that you keep a copy of the signed receipt of Privacy Notice for your records

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