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Medical Records and the Law

Medical Records and the Law

Medical Records and the Law

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HIPAA Security Rule 473sor becomes aware. 129 These m<strong>and</strong>ates ensure that group health pl<strong>and</strong>ocuments will require <strong>the</strong> sponsor to protect <strong>the</strong> ePHI it creates or receiveson behalf of <strong>the</strong> plan, except for ePHI disclosed to a plan sponsorthat is summary health information or enrollment/disenrollment informationdiscussed in <strong>the</strong> privacy regulations.Policies, Procedures, <strong>and</strong> DocumentationThe Security Rule requires that covered entities develop <strong>and</strong> implementpolicies <strong>and</strong> procedures designed to enable <strong>the</strong>m to meet <strong>the</strong>st<strong>and</strong>ards of <strong>the</strong> rule. 130 These policies must be in written (includingelectronic) form, <strong>and</strong> must be maintained for six years from <strong>the</strong> later of<strong>the</strong> date <strong>the</strong>y were created <strong>and</strong> <strong>the</strong> date <strong>the</strong>y were last in effect. 131 Thecovered entity’s documentation should also include a record of actionsit has taken in compliance with <strong>the</strong> Security Rule. 132 Thus, security riskassessments, interventions in response to security incidents, implementationof security safeguards, <strong>and</strong> o<strong>the</strong>r actions specified in <strong>the</strong> ruleshould all be in <strong>the</strong> covered entity’s record of security compliance. If acovered entity amends its policies <strong>and</strong> procedures for any reason, <strong>the</strong>entity must also document those revisions. Finally, a covered entitymust periodically review its policies <strong>and</strong> procedures <strong>and</strong> make any revisionsrequired by environmental or operational changes. 133 The frequencywith which a covered entity conducts its reviews will dependupon <strong>the</strong> entity’s size, configuration, business environment, operationalchanges, <strong>and</strong> <strong>the</strong> particular security measures already implemented. 134Security Requirements in Health Data NetworksIn any health data network, <strong>the</strong> HDN or <strong>the</strong> participating covered entitieswill be required to implement for <strong>the</strong> HDN operations all <strong>the</strong> securitymeasures that meet <strong>the</strong> st<strong>and</strong>ards set forth in <strong>the</strong> SecurityRule—including assessing controls <strong>and</strong> tracking methodologies <strong>and</strong>ensuring that <strong>the</strong> EHRs it maintains or uses will be free from improper12945 C.F.R. § 164.314(b).13045 C.F.R. § 164.316(a).13145 C.F.R. § 164.316(b)(2)(1).13245 C.F.R. § 164.316(b)(1)(ii).13345 C.F.R. § 164.316(B)(2)(iii).13468 Fed. Reg. 8361 (Feb. 20, 2003).

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