GENETIC INFORMATION IN ELECTRONIC HEALTH RECORDS AND NETWORKS Mark A. Rothstein, J.D. Herbert F....
29
GENETIC INFORMATION IN ELECTRONIC HEALTH RECORDS AND NETWORKS Mark A. Rothstein, J.D. Herbert F. Boehl Chair of Law and Medicine Director, Institute of
GENETIC INFORMATION IN ELECTRONIC HEALTH RECORDS AND NETWORKS
Mark A. Rothstein, J.D. Herbert F. Boehl Chair of Law and Medicine
Director, Institute of Bioethics, Health Policy and Law University
of Louisville School of Medicine 2009
Slide 3
FOCUS OF THIS TALK I.Changes in the quantity and quality of
genetic information in health records. II.Characteristics of the
emerging Nationwide Health Information Network. III.Uses and
disclosures of health information beyond health care settings.
Slide 4
I.GENETIC INFORMATION TRADITIONALLY CONTAINED IN PAPER HEALTH
RECORDS Family health history (3 generations if possible) Medical
geneticMendelian disorders in informationaffected families (e.g.,
test results, counseling records, diagnostic, treatment)
Slide 5
GENETIC INFORMATION INCREASINGLY FOUND IN ELECTRONIC HEALTH
RECORDS Complex disorders E.g., cancer, heart disease Genomic
information 1500+ genetic tests GWAS Pharmacogenomics Drug
selection and dosing Toxicogenomics Risk assessment and medical
monitoring
Slide 6
VALUE OF ELECTRONIC HEALTH RECORDS TO CLINICAL GENETICS 1.There
are only about 1,500 active board-certified clinical geneticists
and 2,000 board- certified genetic counselors. 2.Most primary care
physicians lack the training or expertise in genetics.
Slide 7
3.EHRs can help standardize and organize pedigree and other
data collection. 4.EHRs can provide essential clinical decision
support.
Slide 8
II.NATIONWIDE HEALTH INFORMATION NETWORK Network of networks
Interoperable Longitudinal Comprehensive
Slide 9
ADVANTAGES OF THE NHIN 1.Enhance coordination of care 2.Avoid
duplication of services 3.Improve effectiveness of care 4.Improve
efficiency of care 5.Facilitate outcomes and other research
Slide 10
DISADVANTAGE OF THE NHIN (FOR PRIVACY) It eliminates the chaos
of disaggregated, unconnected, fragmented, and largely paper-based
health records.
Slide 11
KEY PRIVACY ISSUES TO BE RESOLVED Should patients be allowed to
control access to their records? Should patients be allowed to
control the content of their records?
Slide 12
No: It will make record management more difficult and it will
undermine the integrity and completeness of the records.
Slide 13
Yes: 1. Unless individuals can control the content of their
records, they will opt-out of the NHIN. 2.Much sensitive health
information is not needed for current health care needs. 3.If
patients fear a loss of privacy, they might refuse to seek care for
these conditions, thereby endangering themselves and possibly the
public.
Slide 14
Should any special protections be put in place for certain
classes of sensitive medical information, such as mental health,
substance abuse, STDs, genetic test results, etc.?
Slide 15
NCVHS (Feb. 2008): The design of the NHIN should permit
patients to elect to sequester sensitive health information in one
or more predefined categories.
Slide 16
Some examples of categories for consideration: Domestic
violence information Genetic information Mental health information
Reproductive health information Substance abuse information
Slide 17
AMERICAN RECOVERY AND REVINVESTMENT ACT (2009) (i)Technologies
that protect the privacy of health information and promote security
in a qualified electronic health record, including for the
segmentation... Title XIII. Health Information Technology for
Economic and Clinical Health Act (HITECH Act) Section 3002. HIT
Policy Committee Areas for Consideration
Slide 18
... and protection from disclosure of specific and sensitive
individually identifiable health information with the goal of
minimizing the reluctance of patients to seek care (or disclose
information about a condition) because of privacy concerns, in
accordance with applicable law, and for the use and disclosure of
limited data sets of such information. ARRA 3002(b)(2)(i).
Slide 19
OTHER QUESTIONS TO RESOLVE RELATED TO SEQUESTERED HEALTH
INFORMATION CLINICAL DECISION SUPPORT (Should it scan sequestered
information?) EMERGENCY ACCESS (How would a break the glass feature
work?) NOTATIONS TO PHYSICIANS (Should they identify the
category?)
Slide 20
HIPAA PRIVACY RULE 1.Only designed to protect health
information in the payment chain. 2.No federal enforcement or
private remedies. 3.Without comprehensive health privacy
legislation, the NHIN will diminish current (indirect) privacy
protections.
Slide 21
SOME NON-COVERED HEALTH-CARE PROVIDERS Athletic trainers Blood
banks Concierge physicians Cosmetic medicine Employer health
clinics Health and fitness clubs Home testing laboratories
Nutritional counselors Reproductive health services Urgent care
facilities
Slide 22
III.DISCLOSURES BEYOND HEALTH CARE SETTINGS
Slide 23
Each year in the U.S. there are about 25 million authorizations
for the compelled disclosure of health records in various contexts,
such as the following: Employment entrance examinations (10.2 M)
Individual life insurance applications (6.8 M) Individual health
insurance applications Individual long-term care insurance
applications Individual disability insurance applications
Slide 24
Individual and group disability insurance claims Automobile
insurance personal injury claims Social Security Disability
Insurance applications Workers compensation claims Veterans
disability claims Personal injury lawsuits
Slide 25
For the vast majority of these authorizations, there are no
limits placed on the scope of the information disclosed. Even where
there are limits, in a paper-based health records system there is
no practical way to limit the scope of the disclosure. So,
custodians of the records send everything.
Slide 26
Today, everything means all the records from a single provider
or entity. With the NHIN, tomorrows everything means everything
from everybody.
Slide 27
Contextual access criteria technology could limit the scope of
these compelled disclosures. NCVHS recommended in 2006 that HHS
begin development of these tools. So far, there has been no
progress.
Slide 28
CONCLUSION The combination of more genetic information with
EHRs and EHR networks presents a great challenge for health
privacy.