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Geoffrey Milos

Should the FDA stop you from scaring yourself with 23andMe's DNA test? - 0 views

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    "The public humiliation of 23andMe shows how dangerous it is for any company to cross regulators. But there's a benefit derived from upstarts such as 23andMe bristling at creaky, old rules: They force a re-examination of laws that are, sometimes, genuinely outdated."
Geoffrey Milos

HIPAA Privacy Rule and Its Impacts on Research - 0 views

  • The first way, the "safe-harbor" method, is to remove all 18 identifiers enumerated at section 164.514(b)(2) of the regulations 1. Data that are stripped of these 18 identifiers are regarded as de-identified, unless the covered entity has actual knowledge that it would be possible to use the remaining information alone or in combination with other information to identify the subject.
  • 1 The following identifiers of the individual or of relatives, employers, or household members of the individual must be removed: (1) Names; (2) all geographic subdivisions smaller than a state, except for the initial three digits of the ZIP code if the geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people; (3) all elements of dates except year, and all ages over 89 or elements indicative of such age; (4) telephone numbers; (5) fax numbers; (6) email addresses; (7) social security numbers; (8) medical record numbers; (9) health plan beneficiary numbers; (10) account numbers; (11) certificate or license numbers; (12) vehicle identifiers and license plate numbers; (13) device identifiers and serial numbers; (14) URLs; (15) IP addresses; (16) biometric identifiers; (17) full-face photographs and any comparable images; (18) any other unique, identifying characteristic or code, except as permitted for re-identification in the Privacy Rule.
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    includes de-identification by safe-harbor
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