Medical Records and the Law

Disclosures Required by Law 259The Joint Commission on Accreditation of Healthcare Organizations( Joint Commission) also requires compliance with the Safe MedicalDevices Act as one of its accreditation standards. 70The Privacy Rule provides that a covered entity may disclose PHI toa person subject to the jurisdiction of the FDA with respect to an FDAregulated product or activity for which that person has responsibility,for the purposes related to the quality, safety, or effectiveness of theproduct or activity. 71 This provision would permit a covered entity to:• Collect or report adverse events, product defects, or problems (includingproblems with the use or labeling of a product) or biologicalproduct deviations• Track FDA regulated products• Enable recalls, repairs or replacement, or lookback (including locatingand notifying individuals who have received products that havebeen recalled, withdrawn, or are the subject of the lookback)• Conduct post-marketing surveillance 72The terms used in this section of the Privacy Rule have both their commonlyunderstood meanings and any specialized definitions createdby the Food, Drug, and Cosmetic Act. 73 Therefore, covered entitiesshould be familiar with the interplay of HIPAA and that act with respectto disclosures to the FDA.Communicable DiseasesCommunicable disease reporting laws require hospitals and practitionersto inform public health authorities of cases of infectious, venereal,or sexually transmitted diseases. These are among the oldestcompulsory reporting statutes in many states. The statutes or regulationsusually list the particular diseases that must be reported, and directpractitioners to give local public health officials the patient’sname, age, sex, address, and identifying information, as well as the70Joint Commission on Accreditation of Healthcare Organizations, 2005 ComprehensiveAccreditation Manual for Hospitals, Standard EC.6.10.7.7145 C.F.R. § 164.512(b)(1)(iii).72Ibid.7321 U.S.C. § 321 et seq.; see also 65 Fed. Reg. 82525 (Dec. 28, 2000).