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Fetal Tissue Firms Guilty of Systemic HIPAA Violations

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The U.S. House of Representatives Select Investigative Panel has published the findings from its investigation into the sale of fetal tissue by abortion clinics, revealing systemic HIPAA violations by both abortion clinics and tissue procurement businesses.

An investigation was requested by the Energy and Commerce Subcommittee on Oversight and Investigations following revelations made by undercover journalist David Daleiden.

In 2015, Daleiden arranged a serious of meetings with businesses involved in the fetal tissue procurement industry via the not-for-profit group Center for Medical Progress (CMP).

Daleiden secretly recorded abortion providers – and companies involved in the fetal tissue business – detailing the nature of the business of buying and selling tissues from aborted fetuses. Daleiden’s meetings uncovered some dark truths about the practices employed by abortion clinics to obtain fetal tissue, including how termination procedures were often changed in order to obtain more intact specimens, including the use of illegal abortion procedures. The investigation showed how abortion clinics were selling fetal tissue to improve their bottom lines with profit often placed above patient welfare.

The Select Investigative Panel’s 471-page report is the culmination of a yearlong investigation into the fetal procurement industry. The aim of the investigation was sixfold: To examine the medical procedures and business practices used by the industry; to investigate other relevant matters related to fetal procurement; to review federal funding and support for abortion service providers; to investigate the practice of second and third trimester abortions (including partial birth abortions); to assess medical procedures used to care for a child born alive; and to determine whether there was a need for law changes and/or further regulation of the industry.

The investigation centered on the tissue procurement company StemExpress and three Californian abortion clinics: Two operated by Planned Parenthood and one operated by Family Planning Specialists Medical Group.

Planned Parenthood and StemExpress Violated the HIPAA Privacy Rule

The investigation revealed that StemExpress and the Californian abortion clinics: Planned Parenthood Mar Monte (PPMM), Planned Parenthood Shasta Pacific (PPSP), and Family Planning Specialists Medical Group (FPS), routinely violated the Health Insurance Portability and Accountability Act’s Privacy Rule. The organizations’ HIPAA violations were found to be systemic and occurred over a 6-year period between 2010 and 2015.

While HIPAA Rules are in place to protect the privacy of healthcare patients and prevent unauthorized disclosures of individuals’ identifiable protected health information, the above abortion clinics were discovered to have impermissibly disclosed individual’s PHI to facilitate the sale of human fetal tissue.

Further, some tissue procurement businesses misrepresented that the consent forms used, along with the methods employed to harvest fetal tissue, complied with federal regulations.

The Panel determined that tissue procurement businesses routinely violated the HIPAA privacy rights of women for the sole purpose of making money by selling fetal tissue, and were concerned with profit over patient welfare.

Impermissible Disclosures of PHI

The Panel determined that the fetal tissue trade “did not meet the exceptions for cadaveric organ, eye or tissue transplantation or for research,” and that the HIPAA Privacy Rule had been repeatedly violated. The abortion clinics were discovered to have allowed employees of StemExpress to enter their clinics, view patients’ PHI, interact with patients, and seek and obtain their consent to donate fetal tissues. However, consent to share PHI had not been obtained prior to sharing sensitive information with StemExpress. StemExpress was found to have violated HIPAA Rules by viewing the PHI of women without there being a medically valid reason for doing so.

No HIPAA Business Associate Agreements

The Panel also determined that the consent forms obtained by StemExpress “did not constitute sufficient authorizations for the disclosure of PHI,” and that the information disclosed to StemExpress was not “the minimum necessary information” as required by HIPAA. Abortion clinics are HIPAA-covered entities and their dealings with StemExpress made the company a HIPAA business associate, yet the clinics and StemExpress had not entered into a business associate agreement as required by HIPAA Rules.

While the clinics could have entered into a valid business associate agreement and provided PHI in accordance with HIPAA Rules, they did not, and instead impermissibly shared “the most intimate information about their patients,” and violated patients’ privacy.

The Select Investigative Panel determined that the disclosures were both deliberate and purposeful, with StemExpress employees being provided with full patient charts containing highly sensitive medical information.

While a contractual agreement between the abortion clinics and Planned Parenthood clinics existed, the agreements were not compliant with HIPAA Rules. The report says the agreements with StemExpress instructed the company to “treat the information obtained from patients’ charts in order to preserve the confidentiality of the patients,” but said this “cannot trump a law prohibiting the Planned Parenthood abortion clinics from permitting these disclosures in the first place.”

The Select Investigative Panel’s report says “The Panel’s work has revealed that this corruption extends to the method of obtaining consent from the patient, which is both deceptive and unlawful,”

Recommendations for the Department of Health and Human Services

The panel has made numerous recommendations, including a request that Planned Parenthood is stripped of all federal funding, including reimbursements for Medicaid services. Instead those funds should be made available to healthcare providers that “provide comprehensive preventive healthcare for their patients, and that do not perform abortions,” except in the case of rape or incest or when abortions are required to prevent women from being placed in danger of death.

The potential HIPAA violations have been referred to the Department of Health and Human Services and the Select Investigative Panel has recommended that HHS conducts “greater oversight over misleading consent forms, IRBs, HIPAA violations, and abortion provider competence to care for infants born alive during abortion procedures.”

The sale of fetal tissue by abortion clinics has been condemned by many pro-life groups. Kristan Hawkins, president of Students for Life of America (SFLA), said “It is our deepest hope that Planned Parenthood, StemExpress, their business partners, and these late-term abortionists be brought to swift justice by the immediate investigation and prosecution of the U.S. Department of Justice and various state Attorneys General to whom charges were referred.”

The Select Investigative Panel report can be downloaded on this link.

Author: HIPAA Journal

HIPAA Journal provides the most comprehensive coverage of HIPAA news anywhere online, in addition to independent advice about HIPAA compliance and the best practices to adopt to avoid data breaches, HIPAA violations and regulatory fines.

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