2023 Laws of Puerto Rico › TITLE TWENTY-FOUR - Health and Sanitation (§§ 1 — 15010) › PART VII - Hospitals, Institutions and Health Programs (§§ 3001 — 3891) › Chapter 148B - Birth Defect Monitoring System (§§ 3531 — 3538) › § 3535 - Confidentiality and privacy

All pertinent information gathered and analyzed pursuant to this chapter shall be kept confidential in the sense of the identity of the patient, and be used solely for the purposes described in this chapter.
(a) The data obtained directly from a patient’s medical record is to be used exclusively by the Department of Health and the public or private entities or persons that the Department determines to be necessary to carry out the intent of this chapter. The data is privileged and may not be disclosed or made public in a manner so as to expose to identification any individual whose medical record has been used to obtain data under this chapter.
(b) The information that may lead to the identification of an individual whose medical record has been used for obtaining data under this chapter shall be managed at all times pursuant to applicable Commonwealth and federal regulations.
(c) The Department of Health may publish report analysis results for scientific or public health purposes, ensuring that the identity of individuals is duly protected.
(d) Any gathered and analyzed information shall be:
(1) Confidential, where the identity of individuals shall only be used for purposes of the Monitoring System in order to confirm purposes and make referrals.
(2) Direct access to the information shall be limited to the Department of Health, its personnel and individuals with a valid scientific interest who are also involved in studies related to health, demographics, epidemiology or others. All personnel and individuals must make a written commitment to maintain confidentiality as indicated, even when they have already concluded their work or research.
(3) The Department of Health shall maintain an accurate register of the records of all persons granted access to system information. The register shall include: the name of the person who authorized the access, the name of the user, professional title, organizational affiliation of the person receiving access, date of access, and specific purpose of use. The access register shall be open for public inspection during the working hours of the agency.
(4) Any proposed research to be conducted using system information shall be reviewed and approved by a committee constituted for the protection of human rights which complies with the requirements established by the U. S. Department of Health, pursuant to Part 46 of Title 45 of the Code of Federal Regulations.
(5) No aspect of this section shall prohibit the publication of statistics related to birth defects, stillbirths and miscarriages, that have been compiled and which in no manner identifies individual cases or individual information sources.
Any person who violates a written confidentiality agreement, discloses any information under the provisions of this section, or uses information related to this section in any [manner] other than [that] approved by the committee for the protection of human rights shall be denied future access to confidential information kept by the Department. In addition, said person shall be subject to penalties as established through regulations, pursuant to this chapter. The penalty provided for by this chapter shall not restrict any provisional remedy provided by law for the benefit of the Department or any person.
History —Sept. 16, 2004, No. 351, § 7.