Hipaa for the Family Formation Attorney
| Publication year | 2019 |
| Author | Cynthia E. Fruchtman |
Cynthia E. Fruchtman
The Law Offices of Cynthia E. Fruchtman has maintained a law practice in the area of Assisted Reproduction Technology law since 1990, rated AV by Martindale-Hubbell and Superb 10/10 by Avvo. Her clients include donors, recipients, surrogates, intended parents, agencies, laboratories, clinics and physicians, in all aspects of gamete and embryo donation, surrogacy, and posthumous reproduction. She has also worked with the California legislature, both through her service on various bioethics committees and as a member of the Academy of California Family Formation Lawyers and the American Society of Reproductive Medicine, regarding pending regulation in this area. She has spoken and written extensively at legal and medical conferences on ART related issues. Ms. Fruchtman also practices in the areas of management-side labor and employment and civil litigation. Ms. Fruchtman received her B.A. from Northwestern University in Evanston, Illinois and her J.D. from the Chicago-Kent College of Law in Chicago, Illinois.
The Health Insurance Portability and Accountability Act of 1996 ("HIPAA") is a U.S. law designed to, among other things, establish privacy standards to protect patients' medical records and other health information provided to health plans, doctors, hospitals, and other health care providers.1 HIPAA represents a uniform, federal floor of privacy protections for consumers across the country.
The Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule") under HIPAA gives patients access to their medical records and some control over how their protected health information ("PHI") is used and disclosed.2 PHI includes all health information that identifies or provides a reasonable basis to identify an individual or that could reasonably be believed to be useful to identify the individual, in any form, including digital, paper or oral records, such as:
- Name, address, birth date and Social Security Number;
- An individual's physical or mental health condition;
- Any care provided to an individual; or
- Information concerning the payment for the care provided to the individual.3
Medical record information is not PHI unless it contains some identifying or potentially identifying information about the individual.
There are no restrictions on the use or disclosure of de-identified health information that neither identifies nor provides a reasonable basis to identify a patient.4There are two ways to de-identify information: (1) have a qualified statistician make a formal determination of what information can be included; or (2) remove specified identifiers of the patient and of the patient's relatives, household members, and employers. Neither of these methods of de-identification is adequate if the covered entity has any actual knowledge that the remaining information could be used to identify the patient.
HIPAA does not specifically address sperm and egg donation. There are no direct answers in HIPAA for such questions as: who is the patient, who has access to what medical records, and what information is considered PHI. Instead, one section of HIPAA that touches on the procurement of organs should be considered. First, in the HIPAA definitions, "healthcare" means, in relevant part: care, services, or supplies related to the health of an individual. Health care includes, but is not limited to, the following:
(1) The preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of an individual or that affects the structure or function of the body.5
Second, "treatment" is defined as:
the provision, coordination, or management of health care and related services by one or more health care providers, including the coordination or management of health care by a health care provider with a third party; consultation between health care providers relating to a patient; or the referral of a patient for health care from one health care provider to another.6
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Under these definitions, HIPAA only applies to healthcare-related activities. The procurement or banking of organs, blood (including autologous blood), sperm, eyes or any other tissue or human product is not considered to be health care and the organizations that perform such activities would not be considered health care providers when conducting these functions.7 Thus, those who obtain or store eggs, sperm or embryos are by definition not subject to HIPAA.
Likewise, sperm and egg donors are not covered by HIPAA because they are not receiving healthcare; that is, they are not...
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