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ITAA on proposed med-privacy rules



> http://www.itaa.org/isec/pubs/ecurrent.cfm

>                      E-HEALTH: ADMINISTRATION PROPOSES MEDICAL RECORDS
>                      PRIVACY RULES
>                      HHS Secretary Donna E. Shalala proposed a set of
>                      national standards to protect the privacy of Americans'
>                      personal health records. The standards will apply to
>                      medical records created by health care providers,
>                      hospitals, health plans and health care clearinghouses
>                      that are either transmitted or maintained
>                      electronically, and the paper printouts created from
>                      these records.
> 
>                      Shalala noted that Americans are increasingly worried
>                      that the privacy of their medical information will be
>                      violated. Some have even taken action to avoid creating
>                      a medical record, including withholding information
>                      from their doctors, changing doctors, or even avoiding
>                      care altogether. "We cannot allow the absence of
>                      privacy protections to compromise the quality of care
>                      in our nation," Secretary Shalala said. "Our proposals
>                      will provide Americans with greater peace of mind as
>                      they seek care, yet they are balanced with the need to
>                      protect public health, conduct medical research and
>                      improve the quality of health care for the nation."
> 
>                      The bipartisan Health Insurance Portability and
>                      Accountability Act of 1996 (HIPAA) -- also known as the
>                      Kassebaum-Kennedy law -- called on Congress to enact
>                      comprehensive national medical record privacy standards
>                      by Aug. 21, 1999. If Congress was unable to meet that
>                      deadline, HIPAA required the Secretary of HHS to issue
>                      final regulations by Feb. 21, 2000. HHS's proposal
>                      marks the beginning of that regulatory process.
> 
>                      The proposal reflects the five principles outlined by
>                      Secretary Shalala in September 1997 as part of her
>                      Recommendations for Protecting the Confidentiality of
>                      Individually Identifiable Health Information:
> 
>                         * Consumer Control. The standards provide consumers
>                           with important new rights including, the right to
>                           see a copy of their medical records; the right to
>                           request a correction to their medical records; and
>                           the right to obtain documentation of disclosures
>                           of their health information.
>                         * Accountability. The statute includes new penalties
>                           for violations of a patient's right to privacy.
>                           These penalties include, for violations of the
>                           privacy standards by the persons subject to them,
>                           civil monetary penalties of up to $25,000 per
>                           person, per year, per standard. There are also
>                           substantial criminal penalties applicable to
>                           certain types of violations of the statute that
>                           are done knowingly: up to $50,000 and one year in
>                           prison for obtaining or disclosing protected
>                           health information; up to $100,000 and up to five
>                           years in prison for obtaining protected health
>                           information under "false pretenses"; and up to
>                           $250,000 and up to 10 years in prison for
>                           obtaining protected health information with the
>                           intent to sell, transfer or use it for commercial
>                           advantage, personal gain or malicious harm.
>                         * Public Responsibility. Privacy protections must be
>                           balanced with the public responsibility to support
>                           such national priorities as protecting public
>                           health, conducting medical research, improving the
>                           quality of care, and fighting health care fraud
>                           and abuse. For example, public health agencies
>                           routinely use health records in their efforts to
>                           protect the public from outbreaks of infectious
>                           diseases.
>                         * Boundaries. With few exceptions, an individual's
>                           health care information should be used for health
>                           purposes only, including treatment and payment.
>                           For example, a hospital could use personal health
>                           information to provide care, teach, train and
>                           conduct research and ensure quality. However,
>                           employers who also function as health care
>                           providers or health plans would be barred from
>                           using information for non-health purposes like
>                           hiring, firing or determining promotions.
>                           Similarly, insurers could not use such information
>                           to underwrite other products, such as life
>                           insurance.
>                         * Security. Organizations that are entrusted with
>                           health information must protect it against
>                           deliberate or inadvertent misuse or disclosure.
>                           The proposed standards would require each covered
>                           organization to establish clear procedures to
>                           protect patients' privacy, designate an official
>                           to monitor that system and notify their patients
>                           about their privacy protection practices. In
>                           addition, those who get information and misuse it
>                           would be subject to the penalties outlined in the
>                           proposal.
> 
>                      The proposed standards would enhance the protections
>                      afforded by many existing state laws. In circumstances
>                      where the federal rules and state laws are in conflict,
>                      the stronger privacy protection would prevail. The
>                      proposed privacy standards would apply to consumers
>                      whether they are privately insured, uninsured or
>                      participants in public programs such as Medicare or
>                      Medicaid.
> 
>                      While the privacy standards proposed are a significant
>                      step toward protecting patients' confidentiality, HHS
>                      does not currently have the authority to protect all
>                      medical records. Under HIPAA, HHS does not have the
>                      authority to protect records that are maintained in
>                      paper form only. HIPAA also does not allow HHS to issue
>                      standards for records that are maintained by other
>                      insurers, or by employers for worker's compensation
>                      purposes. The proposed rule does not establish
>                      appropriate restrictions on the use or redisclosure of
>                      such information by likely recipients, such as
>                      researchers, life insurance issuers, marketing firms,
>                      or administrative, legal and accounting services.
> 
>                      HHS also lacks the authority to provide Americans with
>                      the right to take action in court when their medical
>                      information is used inappropriately -- a critical
>                      consumer protection that only Congress can provide. The
>                      Clinton Administration has called upon Congress to
>                      close these important gaps and enact comprehensive
>                      national legislation to ensure that all medical records
>                      are protected.
> 
>                      The proposed rule will be open for comment from the
>                      public for 60 days.
> 
>                      In addition to the proposed HHS regulation, several
>                      medical records legislative initiatives are currently
>                      under consideration:
> 
>                         * HR 1057, the Medical Information Privacy and
>                           Security Act, introduced on March 10, 1999 by Rep.
>                           Ed Markey (D-MA) and cosponsored by 41 Democratic
>                           Representatives and Delegates.
>                         * HR 1941, the Health Information Privacy Act,
>                           introduced on May 25, 1999 by Rep. Gary Condit
>                           (D-CA), and cosponsored by 65 Democratic
>                           Representatives and Delegates. (There is
>                           substantial overlap in their co-sponsorship lists
>                           of HR 1057 and 1941).
>                         * HR 2470, the Medical Information Protection and
>                           Research Enhancement Act of 1999, introduced on
>                           July 12, 1999 by Rep. James Greenwood (R-PA), and
>                           cosponsored by 8 Republicans and 2 Democrat (Rep.
>                           Earl Hilliard and Rep. William Lipinski).
>                         * S 573, the Medical Information Privacy and
>                           Security Act, sponsored by Sen. Pat Leahy.
>                         * S 881, the Medical Information Protection Act,
>                           sponsored by Sen. Bob Bennett.
>