JRI Health on New S. 1360 - Sign-On Letter

[James Love <love@Essential.ORG>]

  The following is a letter that is being circulated by the JRI Health Law 
  Institute expressing objections to the new draft of S. 1360.  If you have 
  questions, or want to sign on, contact A.G. Breitenseten, at the address 
  below.  A.G. also has a copy of a draft bill on medical records privacy 
  which was put together for the Medical Privacy Coalition.  
  
  -----------------
  A.G. Breitenstein, Director, The JRI Health Law Institute
  130 Boylston Street, Boston, MA 02116
  Voice: (617) 457-8150, Fax: (617) 457-8133, E-mail: ag@jri.org
  ------------------------
  
  
  April 23, 1996
  
  The Honorable Nancy Landon Kassebaum
  United States Senate
  302 Russell Senate Office Building
  Washington, D.C. 20510
  
  Dear Madam Chairman:
  
  	Having reviewed the changes of S.1360 submitted on 4/10/96, it is
  evident that a commendable debate has begun with regard to what is truly
  necessary to protect patient confidentiality.  We would like to thank the
  Committee and their staff for the work that has been dedicated to this
  draft.  It is clear, however, that the debate that has been set in motion
  must continue if we are to achieve the laudable goals articulated in the
  bill's purpose.  We still oppose the draft of the bill in its current
  form.  Although some changes have been made, many key issues remain
  unaddressed.  We believe that the changes that have already been suggested
  in the Medical Privacy Coalition's discussion draft embody the full
  potential of S.1360 and we urge the committee to adopt them as fully as
  possible. 
  
  	As a general matter, the revised provisions of S.1360 do not
  consistently adhere to the fundamental principles on which any medical
  privacy bill should be based: 
  
   	Right to Privacy - Individuals have a right to privacy with respect to
  their personal medical information; 
  
   	Informed Consent - An individual's right to privacy cannot be waived
  unless that individual is afforded meaningful notice and informed consent; 
  
   	Compelling Public Interest - In the absence of an informed consent, an
  individual's right of privacy with respect to personal medical information
  shall not be eliminated or limited except in circumstances prescribed by
  statute where there is an overwhelming and compelling public interest. 
  
  As we have previously stated, preservation of the right to privacy for
  personal medical information is essential to quality medical care.  If
  patients cannot communicate in confidence with their treating physician
  (or other health care giver), the physician will not be able to obtain the
  information that is needed for effective diagnosis and treatment.  Thus,
  protection of the right to privacy is crucial to preservation of the
  physician/patient relationship which is the cornerstone of our health care
  delivery system. 
  
  Flowing from this understanding, we would like to raise the following
  specific concerns: 
  
   Stricter limits must be placed on insider access.
  	-A trustee should not be able to condition employment or services
  on the receipt of an authorization for use and/or disclosure of health
  information. 
  	-Patients should be given a specific list of those individuals
  within a trustee who will have access to their health information and be
  able to control who may appear on that list.
  	-Patients should have full knowledge of a trustee's use of an
  independent contractor.
  	-All trustees, including health care providers, should maintain a
  readily understandable audit trail of disclosures.  
  	
   Longitudinal health databases should not be allowed without consent.
  
  	-No patient should be forced to have their information placed in a
  longitudinal database without their consent.
  	-The only possible exception we would consider would be where pure
  research were being performed and where the patient has the opportunity
  and absolute ability to "opt out" of such research. 
  
   No Health Information should be disclosed or used without the Informed 
  Consent of the Patient.
  
  	-True informed consent appears nowhere in the current draft.  Not
  only must this concept be included, but further procedural safeguards and
  notice requirements must be incorporated to support such consent.  Again
  we refer to the specific suggestions made in the Medical Privacy
  Coalition's discussion draft. 
  	-The purpose for any use or disclosure must be specified in any
  consent signed by an individual. 
  
   Stronger state laws should not be prohibited.
  	-The current draft still preempts state law.  We would strongly
  urge the removal of this section as no federal law should ever serve as a
  ceiling for protective state action.  Further, the current language allows
  weaker laws that "regulate" public health and mental health to
  remain.  This would allow worse state laws to remain and preempt the
  addition of better laws.  This is a loss, even from the earlier draft of
  S.1360. 
  
  Specific conditions for access to identifiable health information must be 
  set out for health insurers, oversight and public health officials, 
  researchers, accreditation agencies, and in emergency circumstances.  
  	-The current provisions simply allow full access without
  restriction.  These entities must have a compelling public purpose to
  access health information without consent.  The Coalition set out very
  specific requirements for each of these entities in its discussion draft. 
  
   Limitations on law enforcement access must be appreciably strengthened.  
  	-Although a clear and convincing standard has been added, it is
  still only with regard to the "relevance" of the information.  The
  standard should be "clear and convincing evidence that the information is
  necessary."  In addition, the Medical Privacy Coalition suggested a number
  of procedural safeguards, such as a requirement that a party seeking
  health information provide the court with a proffer of evidence specifying
  the grounds for such an inquiry and review of information at the court. 
  These suggestions among others are very important to protecting privacy. 
  
  The above should not be regarded as an exhaustive list of the concerns held 
  by the undersigned.  The Medical Privacy Coalition's discussion draft 
  submitted to the Committee most fully details the suggestions we hope to see 
  incorporated into the final version of the bill.  This letter is, however, 
  intended to address our major concerns. With that said we recognize that a 
  variety of both good and bad alternatives to S.1360 are currently being 
  considered by Congress.  We would very much hope that the debate continues 
  within the framework that has been created by S.1360.
  
  We will support of a modified version of S.1360 if the Committee will commit 
  to correcting the outstanding deficiencies noted above.  We would like to 
  reiterate that we feel that the work that has been done thus far has 
  contributed to the creation of a robust debate about what should be done to 
  protect the privacy of patients.
  
  We look forward to a continued discussion of the very vital issues described 
  above.
  
  Sincerely,
  (Signatories as of 4/23/96)
  
  Denise Nagel, MD 
  Director, Medical Confidentiality Project of the Coalition for Patient Rights
  
  A.G. Breitenstein
  Director, JRI Health Law Institute
  
  
  
  
  
  cc: 	The Honorable Robert Bennett
  	The Honorable Edward Kennedy
  	The Honorable Patrick Leahy
  __________________________________________
  A.G. Breitenstein, Director, The JRI Health Law Institute
  130 Boylston Street
  Boston, MA 02116
  
  Voice: (617) 457-8150
  Fax: (617) 457-8133
  E-mail: ag@jri.org
  JRI on the Web: http://www.jri.org/jrihealth
  HIV InfoWeb: http://www.jri.org/infoweb