Adam
Tanner is the author of the new book Our Bodies, Our Data:
How Companies Make Billions Selling Our Medical Records.
In
1956, the head of one of Madison Avenue’s leading medical
advertising agencies dispatched a copywriter to West Germany
to set up a new company for producing surveys of the pharmaceutical
market. The young executive had never been abroad and spoke
no German.
The
firm, initially called Institut für Medizinische Statistik,
quickly won clients by providing insights on which drugs sold
well in which markets. Drug companies eagerly bought these reports,
and IMS expanded to other European countries, North and South
America, and Asia.
Today,
the US-based data-mining firm, recently renamed QuintilesIMS,
operates in more than 100 countries and is at the heart of a
for-profit global trade in anonymized patient data. The $20
billion company assembles dossiers on more than half a billion
patients worldwide from physician records, prescriptions, insurance
claims, lab tests and more.
US
competitors include IBM Watson Health, GE Healthcare, LexisNexis
and firms linked to insurers such as UnitedHealth’s Optum
Anthem’s HealthCore and Blue Cross Blue Shield’s
Blue Health Intelligence. Rivals exist in other countries as
well.
Privacy
can be at risk. Patient dossiers omit obvious identifiers such
as names and national ID numbers, but have become more vulnerable
to re-identification as computing power advances and a constant
influx of data provide ever more clues into who is who and where
patients live and work. Another complicating issue is the growing
availability of insights from DNA testing, identifying by its
very nature.
The
growing possibility of re-identification from such dossiers
poses risks of discrimination against people with mental health
issues or any array of medical complications. In some cases,
such action would be legal, such as in denying life insurance,
and in others not, such as in hiring and promotion decisions.
Medical information could be used to blackmail and embarrass
anyone from common citizen or national leader.
Data
miner dossiers are legal under US rules and serve mostly to
help pharmaceutical firms market and advertise their drugs.
Data miners also highlight the promise of big data leading to
new discoveries and cures. “The future of medicine rests
on data: the evidence that is the basis for the discovery, development
and dispensing of prescription products and all other healthcare
decisions,” noted QuintilesIMS in an October report. “Mastering
the collection and interpretation of data is therefore vital
for the vitality and continued global contributions of the biopharmaceutical
industry.”
So
far, industry executives admit to garnering interesting insights
rather than stunning breakthroughs.
The
ability of commercial firms to assemble dossiers on individuals
comes at a time that few Americans have access to complete records
for their own health care. The fractured nature of US medicine
complicates this issue compared to countries with national systems.
Officials
in many countries suggest that they enjoy stronger privacy protections
than the United States, either through law or tradition. Yet
increasingly, American-style accumulation of sensitive medical
data on millions of patients is becoming commonplace.
For
example, many Japanese officials contend that the aggregating
and selling anonymized patient files does not occur in Japan
as it would violate Japanese sensibilities. “The difference
between IMS in Japan and in the United States, in Japan they
treat data and privacy in a more sensitive way,” said
Yoshitake Yokokura, president of the influential Japan Medical
Association. “Medicine should be for the public benefit,
not for business.”
For-profit
ventures are expected to secure patient consent. Yet IMS advertises
the sale of Japanese longitudinal data, including “actual
prescription data from pharmacy records for individual patients.”
Japan’s guidelines on selling anonymized patient data
are blurred because the nation lacks US-style privacy rules,
including the Health Insurance Portability and Accountability
Act. Officials often speak of a gray zone of practices neither
explicitly allowed nor forbidden.
Data
miners typically do not seek patient consent and maintain that
properly anonymized information does not belong to an individual.
A group of patients and doctors in South Korea disagreed and
launched a legal case against IMS in 2014. After a whistleblower
released anonymized records from some of these data-miner transactions,
it turned out that a simple code could unlock the patients’
national ID numbers.
Sung
Bae Kim, among the South Korean physicians who brought the lawsuit,
described his shock: “If it’s syphilis or hypertension
or diabetes, if you have information about me without my understanding.
If they do not get consent, they have no right. It is very unethical.”
QuintilesIMS
is fighting the lawsuit and defends its practices, arguing that
only anonymous healthcare data is mined. “IMS Health then
takes further steps to ensure the information remains anonymous,
such as additional cryptographic coding,” said spokesman
Tor Constantino.
Europe
boasts of stronger personal data protections than the United
States. Yet data miners advertise anonymized patient dossiers
from a number of European Union countries. For example, in Germany
QuintilesIMS sells details from electronic health records, prescriptions,
hospital discharges and patient registries.
Some
European countries such as the Nordics maintain national health
databases with information on patients suffering from heart
disease, cancer and HIV among other ailments. Such efforts,
led by the state, are not aimed at making a commercial profit.
Some
IMS veterans who worked at the company during the era when focus
was limited to broader pharmaceutical market surveys are uneasy
about the commercialization of anonymized patient data that
have become more commonplace over the past two decades.
Former IMS Japan CEO Shunsuke Keimatsu questions the value of
such anonymized individual data for IMS clients and how clients
use the data. He also wonders whether anonymous data may violate
privacy laws. “To be blunt, I feel that they went too
far unless there are legitimate answers to the above two questions,”
he said.
Sabrina
Chan, executive director of the Hong Kong Association of the
Pharmaceutical Industry, expresses a similar sentiment: “No
matter that it is anonymous, the consent from the data owner
is the most important. My principle is without the patient’s
consent, actually it is unethical to disclose their data to
anyone.”
The
trade in patient data is so opaque that many even in health
care and government do not know about it. A top Japanese government
official who did not want to be named insisted initially that
trade in anonymized patient data did not occur in his country.
He then expressed surprise as a researcher detailed how such
a trade has emerged in Japan.
Part
of the problem is that data miners are reluctant to talk publicly
about how the process works. “The entire US health care
system, as well as the entire political system, has devolved
into this shadow game,” said Joel Kallich, the founder
of Big Health Data who used to work at Amgen and has consulted
for IMS. He adds that anyone privy to the data can lie, scheme,
manipulate or steal data from the people to whom it belongs.
The
example of Japan and many other countries shows that in the
absence of specific guidance or government restrictions, market
forces will continue to expand personal data collection quietly,
even in a traditionally cautious business climate.
There
is hope that the commercial circulation of anonymized patient
data contributes to science and treatments. Yet given the growing
privacy risks, countries should encourage an open, informed
public debate for shaping regulations on anonymized patient
data in what is increasingly a big and globalized health data
bazaar.
Copyright
© 2017 YaleGlobal and the MacMillan Center
