Under the Federal Health Insurance and Portability Act 1996, regulations have been promulgated that took effect in April 2003 that apply a privacy protection regime to personal health information. The regulation is called the HIPAA Privacy Rule and cited as 45 Code of Federal Regulations Parts 160 and 164.
Scope
The rule applies to all covered entities that are health plans, health care clearing house and health care providers who transmit personal health information in connection with transactions, such as billing and payment for services or insurance, in respect of which the Department of Health and Human Service has established standards.
The rule generally prohibits health care providers from using or disclosing
individually identifi able health information, called “protected health information” for purposes other than treatment except in defi ned situations. The fi rst of these is with consent, called authorisation, to which the standards of consent for involvement in research are applied. The second is if the data are de-identifi ed, or are in limited data sets (established by removing specifi ed identifi ers). The third is with waiver of authorisation by an institutional review board, applying similar procedures and requirements as apply to the exercise of their power to waive consent for research. The rule also allows use of protected health information for research purposes if waiver of authorisation (consent) is given by a privacy board, a new body established under the rule.
The regulation is highly detailed, but its key defi nitions are:
Health information means any information, whether oral or recorded in any form or medium, that:
(1) Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and
(2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.
Individually identifi able health information is information that is a subset of health information, including demographic information collected from an individual, and: (1) Is created or received by a health care provider, health plan, employer, or
(2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and
(i) That identifi es the individual; or
(ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual.
Protected health information means individually identifi able health information: (1) Except as provided in paragraph (2) of this defi nition, that is:
(i) Transmitted by electronic media;
(ii) Maintained in any medium described in the defi nition of electronic media at § 162.103 of this subchapter; or
(iii) Transmitted or maintained in any other form or medium. (2) Protected health information excludes individually identifi able health
information in:
(i) Education records covered by the Family Educational Right and Privacy Act, as amended, 20 U.S.C. 1232g; and
(ii) Records described at 20 U.S.C. 1232g(a)(4)(B)(iv).
Health care means care, services, or supplies related to the health of an individual. Health care includes, but is not limited to, the following:
(1) 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; and
(2) Sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription.
Health care provider means a provider of services (as defi ned in section 1861(u) of the Act, 42 U.S.C. 1395x(u)), a provider of medical or health services (as defi ned in section 1861(s) of the Act, 42 U.S.C. 1395x(s)), and any other person or organization who furnishes, bills, or is paid for health care in the normal course of business.
NEW ZEALAND
The Privacy Act 1993 appears to follow a similar pattern to the Australian federal equivalent, in that it is expressed to fulfi l New Zealand’s obligations as a member of the OECD, but it adopts a simpler comprehensive scheme. Section 46 of the Act permits the Commissioner to approve codes of practice and, in 1995 (amended in 2000), he approved the Health Information Privacy Code, which is directly relevant to the present context. Section 46 permits approved codes to vary or relax the provisions of principles under the Act.
In this account of the legislation, the relevant provisions of this Act and the Code are described and compared.
Scope
The Act
The Act applies to “agencies” that are defi ned in section 2 to include both public and private sector entities, with specifi c exclusion of some specifi c public sector bodies: “Agency’’-
(a) Means any person or body of persons, whether corporate or
unincorporate, and whether in the public sector or the private sector; and, for the avoidance of doubt, includes a Department; but
(b) Does not include- (i) The Sovereign; or
(ii) The Governor-General or the Administrator of the Government; or (iii) The House of Representatives; or
(iv) A member of Parliament
(iv) A member of Parliament in his or her offi cial capacity; or (v) The Parliamentary Service Commission; or
(vi) The Parliamentary Service, except in relation to personal information about any employee or former employee of that agency in his or her capacity as such an employee; or (vii) In relation to its judicial functions, a court; or
(viii) In relation to its judicial functions, a [tribunal]; or (ix) An Ombudsman; or
(x) A Royal Commission; or
(xi) A commission of inquiry appointed by an Order in Council made under the Commissions of Inquiry Act 1908; or
(xii) A commission of inquiry or board of inquiry or court of inquiry or committee of inquiry appointed, pursuant to, and not by, any provision of an Act, to inquire into a specifi ed matter; or (xiii) In relation to its news activities, any news medium.
The Code
The Code, in paragraph 3, adapts the defi nition of agency to specify: (a) an agency which provides health or disability services;
(b) within a larger agency, a division or administrative unit (including an individual) which provides health or disability services to employees of the agency or some other limited class of persons;
(c) a person who is approved as a counsellor for the purposes of the
Accident Insurance Act 1998;
(d) a school, faculty or department of a tertiary educational institution which provides the training or a component of the training necessary for the registration of a health professional;
(e) an agency having statutory responsibility for the registration of any registered health professionals;
(f) a health professional body;
(g) persons appointed or designated under the Health and Disability Commissioner Act 1994;
(h) the Health Funding Authority or an agency that has been declared by the Minister of Health by notice in the Gazette to be a funder for the purposes of the Health and Disability Services Act 1993;
(i) an agency which provides health, disability, accident or medical insurance, or which provides claims management services in relation to such insurance, but only in respect of providing that insurance or those services;
(j) an accredited employer under the Accident Insurance Act 1998; (k) an agency which provides services in respect of health information,
including an agency which provides those services under an agreement with another agency;
(l) a district inspector, deputy district inspector or offi cial visitor appointed pursuant to section 94 of the Mental Health (Compulsory Assessment and Treatment) Act 1992;
(m) an agency which manufactures, sells or supplies medicines, medical devices or related products;
(n) an agency which provides health and disability services consumer advocacy services;
(o) the Department for Courts but only in respect of information contained in documents referred to in section 44(2) of the Coroners Act 1988; (p) the agencies specifi ed in Schedule 1.