Paper or Plastic? From Paper Records to Electronic Database
Dr. Edwards is very excited about the database he has developed.
He has been a clinical psychologist and researcher for fifteen
years and has strongly advocated for the use of computers in his
field since his med school days. Several years ago, looking at the
shelves and drawers filled with patient files, he began to think
about data management. He came up with the idea of developing a
multimedia, fully integrated database that would allow physicians
and researchers to store, analyze and query patient/subject
information quickly and easily. Through such a resource, he
thought, he could maximize the utility of large collections of
data, allowing researchers to ask questions currently impossible to
address, due to the logistics of handling such large, heterogeneous
data sets. Edwards envisioned a database that would allow
researchers to record and track all aspects of an experiment
including patient samples and records (everything from name and
address to CAT scans), experimental reagents, protocols, raw data
and primary analysis. It is a fantastically powerful tool with
tremendous potential.
The Medusa database (Multimedia Data Storage and Analysis) was
developed in Edwards's lab, at a prominent teaching hospital, using
data from his own studies of ADHD and bipolar disorder. Medusa is
fairly robust for his data set, but needs to be beta-tested with a
range of data types and formats that are not commonly encountered
in clinical psychology (e.g., DNA sequence data or results from
animal breeding experiments). He meets with several labs on the
medical campus and gives presentations on Medusa in an effort not
only to advertise, but also to recruit high-profile labs in which
to beta-test his product. During demonstrations, all patient names
are encrypted and family relationships obscured. Edwards navigates
through Medusa, showing off the ease with which one can toggle
between a patient's blood chemistries and the results of behavioral
tests. He convinces three labs with large ongoing projects to
import their data into Medusa, helping him work out bugs and
continue to develop the design and utility of his database. He
knows that if all goes well, his name and that of Medusa will be
mentioned in future publications out of the beta-labs, which will
be important when he takes his database to market.
When Edwards began developing Medusa, he did not inform his
patients or ask their permission to be included. He believes that
storing the data in Medusa is equivalent (if not superior) to
storing it in folders in file cabinets and is simply the best way
for him to provide care to his patients.
Discussion Questions:
- Is there a substantive difference between paper records and
Medusa?
- Is Edwards justified in using patient information for database
development and promotion? Why or why not?
Currently, the database is located in Edwards's lab on only one
computer, which is accessible over the web. The bioinformatics
staff of the respective beta-labs must learn the data structures
and file formats used in Medusa, as well as how to manipulate the
encryption utility. That will enable them to devise ways to import
their own labs' data, which may be markedly different than the data
from Edwards's lab. In order to import the data, a few individuals
must have full access to the database, which means that they also
have full access to Edwards's data set. To avoid this exposure,
Edwards would have had to set up a complete duplicate database,
which would be onerous and time-consuming. Edwards provides each
beta-lab programmer with the encryption key; Amy is one such
database programmer. While learning Medusa, Amy has access to
complete patient files and experimental data stored in the
database, although she has no need to look through these files.
Periodically, her supervisor asks her to update the rest of the lab
on her progress. During her lab presentations, it is easier to
demonstrate much of Medusa's functionality without the encryption
in place; although Edwards is working on it, the key currently must
be entered each time a query is submitted, which is cumbersome and
slow for demonstration purposes.
Discussion Questions:
- If Edwards had sought his patients' informed consent for use in
the database, what would the consent form look like? E.g., what
risks and benefits would have to be disclosed?
- Given this additional information, do you feel differently
about Edwards's use of patient information in the development and
promotion of Medusa? Why or why not?
- Where is the line between legitimate sharing of information and
breech of physician-patient confidentiality?