Personal Digital Assistants (PDAs) and Records

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  1. What is a PDA?
  2. What kind of records might I have on my PDA?
  3. What should I do with Agency records created on my PDA?
  4. After I have captured Agency records, do I need to delete them from my PDA?
  5. Do I need to set up any special security on the PDA?
  6. Is the information on my PDA subject to FOIA, subpoena, and discovery?
  7. My PDA was not provided by the Agency. Do these rules still apply to me?
  8. Do these guidelines apply to FDA contractors?
  9. How can I get additional guidance?

1. What is a PDA?

A personal digital assistant (PDA) is a handheld device that usually includes a clock, calendar, address book, task list, memo pad, and calculator. PDAs usually synchronize with a PC or home computer. Palm Pilots, Blackberries and Pocket PCs are all considered types of PDAs.

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2. What kind of records might I have on my PDA?

Common Agency records maintained on PDAs include e-mail, calendars, and other information related to your FDA work.

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3. What should I do with Agency records created on my PDA?

You should capture records from your PDA into your organization's recordkeeping system on a regular basis. A recordkeeping system may be either electronic or hard-copy, as long as records are organized and accessible.

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4. After I have captured Agency records, do I need to delete them from my PDA?

No, you may maintain convenience or reference copies on your PDA. Both official records and convenience copies should be disposed of in accordance with applicable Agency record schedules.

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5. Do I need to set up any special security on the PDA?

Information stored on your PDA requires the same degree of protection as similar FDA information stored elsewhere, whether on a LAN, PC, removable electronic media, or paper. Consult your organization's policy on handheld computing to see if there are special security requirements. Also, it is a good idea to enable the password lock feature when the device is not being used, to provide an initial form of protection against unauthorized users.

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6. Is the information on my PDA subject to FOIA, subpoena, and discovery?

Yes, information on your PDA may be requested under FOIA or in response to litigation. The same exemptions apply to the release of PDA information that apply to other FDA records.

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7. My PDA was not provided by the Agency. Do these rules still apply to me?

Yes, if you have Agency records on a personally-owned handheld device, they still need to be captured in an approved recordkeeping system.

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8. Do these guidelines apply to FDA contractors?

Yes, these guidelines apply to FDA contractors and other agents. Contract terms should ensure that contractor systems satisfy legal requirements for creating and maintaining adequate and complete records of FDA transactions.

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9. How can I get additional guidance?

If you have policy questions about your PDAs, contact the FDA appropriate Center/Office Records Liaison Officer.

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