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Compute for personalized medicine
It’s Changing Faster than Moore’s Law, but Is U.S. Policy Keeping Pace?
In 1990, the U.S. launched an audacious scientific endeavor with the potential to changethe practice of medicine when the National Institutes of Health and the Department ofEnergy joined with the international community in a quest to sequence all 3 billion let-ters, or base pairs, in the human genome, which is the complete set of DNA in the humanbody. This concerted, public effort was the Human Genome Project (HGP). By 2000, sci-entists broke the code and paved the way for an explosion of investment in genetic andgenomic testing, generating 116,000 U.S. jobs and USD 16.5 billion in national economicoutput. These developments are being repeated in Oslo, Beijing, and around the world.
Stemming from the human genome sequencing is a new field referred to as personalizedmedicine, where providers and patients use diagnostic tools to identify specific molecularcharacteristics to help assess which medical treatments and procedures are best for thepatient. By combining an individual’s medical history and circumstances with this informa-tion, providers can develop customized treatment and prevention plans for patients whowill benefit, sparing side effects and expense for those who will not. For example, teststhat read the DNA structure of the most common form of leukemia in children havehelped boost the 10-year survival rate from 4 percent in the 1960s to more than 80percent today.1 Using the guidance from genetic tests, in the future physicians will more
be increasingly able to prescribe the right drug, at the right time, in the right dosage.
methods is expected to make whole-genomesequencing both affordable and essential in
giving a multi-faceted view of the patient’s
USD 3 billion to complete in 2001, can now
health, the biological basis of cancer, infec-
be accomplished in about a day for less than
tious diseases, inherited diseases, and drug
USD 10,000 (Figure 1). Soon, that cost will
response. Technology advances will make it
likely drop below USD 1,000. Illumina, whose
possible for the sequencing of individual
HiSeq* DNA sequencing systems produce the
genomes to become the standard and routine
offers its sequencing services in bulk for as
Changing Policy to Capture theOpportunity
Now that technology has moved us towarda new environment where understandingthe genome is leading to unforeseen break-throughs in identifying new strains of com-plex diseases and offering treatments indi-vidualized for patients, we need to rethinkthe laws and regulations governing geneticinformation.
More than 90 percent of U.S. physicians areusing electronic health records (EHRs)according to a May 2013 Accenture report. This is incredible progress and a criticalbasis for becoming the data engine to pro-vide a comprehensive data summary of apatient’s health and well-being. However,we only see the tip of the iceberg until we
Figure 1. Sequencing Cost per Genome (Source: National Institutes for Health)
have the genetic information built into thepatient information document and canensure that the records are available to the
Making genomic data and tools interopera-
patient’s care team Then, through analytics
ble in a secure and trusted way will gener-
medicine will replace today’s trial and error
efforts. That is where policy can help deliv-
er the comprehensive record—by supporting
researchers, and healthcare professionals.
the integration of whole-genome-sequenceddata into health records (including clinical
decision support tools) using the U.S.
"meaningful use" requirements to activate
widespread adoption by providers. This will
value of the data held in millions of patient
not only allow physicians to have a full pic-
face (API) supporting apps and services.
records—data that could help researchers
ture of a patient’s medical history, but it
may also serve as an invaluable platform for
interoperability, scalability, stability,
treat high blood pressure than a less costly
generic, or what the rate of increase is in
markers with clinical data. The EHRs give
the diagnosis of Alzheimer’s. Today, the use of
much-needed context to the genomic infor-
this information is regulated by a series of
mation. Clinical decision support tools inte-
data for disease cures and treatments.
consent requirements constructed for a very
grated with medical records are essential to
different kind of research. In clinical trial
allow physicians easy access to new patient-
research, when comparing groups of patients
appropriate diagnostic tests, as well as to
use of millions of variants for each indi-
taking new drugs to those who take placebos,
automated resources for the interpretation
discreet consent is necessary. But how do we
keep them all? How do we access theinformation we need in real time?
use today’s population data, now document-
mant, and robust to effectively mitigate risk
workarounds when security gets in the way.
groups? And what is appropriate for broad
consent, for now and the future, when look-
ing at de-identified data to use in research
Accountability Act of 1996 (HIPAA) has many
Today, it is not possible to predict which
privacy provisions designed to safeguard medical
changes in DNA sequence lead to clinical con-
information and restrict access to it, yet it serves
sequences. When held against a large reposi-
as an important reminder of how policy can have
tory of other such data, robust patterns and
unintended consequences. Since becoming law,
relationships can be identified which will
HIPAA has had a chilling effect on scientific
require millions of samples from real patients,
investigation. For example, retrospective, chart-
their treatments, and conditions. Researchers
based research is difficult to conduct due to reg-
are hungry for the ability to access data on a
ulatory hurdles, and response rates in follow-up
much wider basis than registries offer today.
investigations are very low given the challenges
Yet, growing concerns regarding the ability to
keep the data private need to be addressed.
Harvard University Professor Latanya Sweeney
Another important privacy and safety provision
published findings in April 2013 showing that
is the Common Rule, which protects patients in
federally funded clinical trials. It requires
researchers to obtain informed consent and
participants in a recent DNA study, highlight-ing the risk that many see to sharing their
puts in place other provisions to protect
patients in those trials, explicitly safeguardingvulnerable populations such as pregnant
To enable greater sharing of patient data for
women, children, and prisoners. The principles
research, privacy and security risks must be
of the Common Rule are also transferred to
kept manageable. De-identification is a key
non-federally-funded research through other
safeguard, but not a panacea. As the Harvard
regulatory guidelines. Thus, the overall system
Since DNA cannot be effectively de-identified,
example shows, there is residual risk with de-
of clinical trials is coordinated to ensure privacy
how do we design informed consent while bal-
identified data that can enable re-identifica-
and safety, and these rules extend to studies
ancing with considerations of patient privacy in
tion and breach, especially with new types of
data, such as DNA, that we are just starting to
patients the tools to decide who will see and
How does the U.S. balance the need for patient
research require some fields, such as the
data that will accelerate research and provide
research/public health or give patient discounts
patient's age or zip code, that would normally
individualized treatments with common and
on health coverage and early access to clinical
be eliminated during de-identification. To keep
rare diseases against the interest in keeping
privacy and security risk manageable, enable
much broader sharing of data, and support
As data sharing increases in scope, research
research that requires more than fully de-
participants will no longer be asked to consent
access by researchers to vast collection of data,
identified data, the best practice of a multi-
to a single study, but rather to make their
but must adhere to the research participants'
layered approach to security should be used.
data available to a large number of researchers,
conditions of access. When and how will partici-
De-identification is combined with other safe-
likely from different countries. Public trust in
pants be allowed to access their own data? We
guards, including encryption, tokenization, and
the procedures used to store and access data
need policies that allow the return of individual
access controls, which must be usable, perfor-
Today’s privacy and consent requirements
Regardless of the stakeholder position on
need a twenty-first-century review of the
products. Because reimbursement for high-
the agency of record, it is time for policy-
data that will allow efficient, secure access for
value products must be driven by true clinical
makers to clarify agency jurisdiction, reduc-
benefit for the covered population, criteria for
appropriately protecting the confidentiality of
demonstrating both clinical utility and validity
growth of this critical industry to the detri-
individual patients. Patients should be empow-
must be developed and standardized. These cri-
ered to have a right to share their data as well
teria can then be used to guide both product
as to protect the data they choose. This will
development and reimbursement decisions.
require new protocols where individuals can
The U.S. has one of the world’s most far-
dictate access to their information for medical
reaching protections for genomic informa-
increase CMS funding unless a comprehensive
or research purposes. Privacy is ensured by
tion. GINA, the Genomics Information Non-
cost analysis is considered, including misallo-
limiting data access to authorized users and
cated treatments, missed diagnosis of early
stage disease, and the total costs of trial and
The penalties for lack of controls need to be
health. GINA creates federal rules to protect
specified, much like the breach notification
regulations in the U.S. HITECH Act, where
employers and insurers. It is a milestone and
institutions are required to alert patients of
Is a new framework needed for regulation of
a best practice for the rest of the world.
clinical laboratory tests that generate genetic-based data? Regulation of in vitro diagnostics in
To use patient-specific health information
available through genomic mapping, we must
Insurers, including Medicare, are funding
remove the stigma associated with genomic
genomic testing for specific chronic diseases—
testing and integrate it ubiquitously as yet
operating under its authority to regulate
like cancer, HIV, and heart disease—in patients
another set of lab test results. If we want to
and their families. This has significantly
increased both predictive and preventative
CMS, operating under the authority of the
options. However, the limits on reimbursement
place both the patient and the healthcare sys-
lower-cost treatments as the new standard
tem at risk. As Congress considers cost-saving
of care. As patients, we can take control and
policies that will transform healthcare delivery,
Are these regulatory systems equipped to deal
manage our diets, behavior, and exercise, but
genomic mapping will need to be one of the
with complex, high-value tests that draw on
not be penalized for what we cannot control.
chief considerations to enable our healthcare
cutting-edge genomics technology to directly
An informed partnership among the patient,
practices to target and accelerate care. Genetic
inform high-stakes clinical decisions? Of the
mapping will provide the research that will lead
two agencies with jurisdiction, CMS has respon-
patients for test results but reward proac-
to savings from eliminating unnecessary tests
sibility for laboratory-developed tests (LDTs)
through its regulation of the quality and safety
standards for labs. The FDA regulates in vitro
Today’s static system of codes prevents the
diagnostic products (IVDs) as medical devices
Centers for Medicare and Medicaid Services
and has stated its authority to regulate LDTs,
How can the U.S. close the loopholes that
(CMS) from differentiating single tests for dis-
but the agency has exercised its enforcement
were left in the Act, including nondiscrimina-
ease rather than creating a dynamic testing
discretion and refrained from regulation.
tion based on genetic information for mort-
system based on the value of the test. CMS
However, the FDA has stated its intention to
gages, long-term care insurance, the disabili-
payment needs to be realigned with the com-
apply risk-based oversight of LDTs as medical
ty and life insurance marketplaces, and cov-
plexity of the test and the risk associated
devices. Final guidance providing illustrative
with the disease. Additionally, CMS should set
examples that distinguish products that will be
standards for the evidence that the agency
subject to pre-market approval from those that
and other payers will require to validate the
benefits of the tests on a value-based cover-
The future is here, the research is ongoing,and the challenge is to integrate the new datainto advanced clinical decision support soft-ware connected to EHRs with the clinicaltraining required to use the patient data andbring this science into daily clinical operations. Centers like Cleveland Clinic are holding sum-mits for clinicians to earn CME credits whilebuilding upon the genetic data that is famil-iar—such as family history—and migrating topharacogenomics and more as clinicians beginto weave these additional sources of data intotheir workflows. At Mayo Clinic, the goal is toget every physician to use personalized medi-cine, starting with an alert system issued bythe EMR. For example, when a physician pre-scribes abacavir, an AIDS drug that causessevere reactions in some people who havecertain genetic variants, the EMR alert popsup and gives the name and pager of an expertin Mayo whom the prescriber can call foradvice. The Clinical Decision Support tool,combined with genomics data, is changingmedicine today.
How to change workflows and educationrequirements to convince doctors to adopt
institutions, technology corporations, and poli-
Five years later, many of the issues remain to
personalized medicine within their practices.
be addressed and resolved. The roadmap is
In 2008, The President’s Council on Science and
In the absence of an open and interopera-
Technology issued “Priorities for Personalized
next-generation sequencing, we need to get
Medicine,” calling for “the Federal government,
the policy right to ensure the benefits from
through the leadership of HHS, to join with the
this miraculous new science, providing indi-
private sector to create a public/ private sector
vidualized treatments for patients at a speed
‘Personalized Medicine R&D Roadmap’ for coordi-
nating discovery and translational research in
personalized medicine.” The report focused on
Integrating personal health into clinical prac-
policy recommendations for technology, regula-
tice requires policy and practice changes
which are today being led by academic medical
1New England Journal of Medicine, 2006, 2001, Personalized Medicine Coalition, 20062Forbes, Harvard Professor Re-Identifies Anonymous Volunteers In DNA Study, April 25, 20133Creating a Global Alliance to Enable Responsible Sharing of Genomic and Clinical Data,http://www.ucsf.edu/sites/default/files/fields/field_insert_file/news/White%20Paper%20May%2029%20DAPG.12.54pm.pdf, May 27, 2013, pp 6-7.
4Personalized Medicine Coalition, Personalized Medicine Regulation Pathways for Oversight of Diagnostics, 2012http://www.personalizedmedicinecoalition.org/sites/default/files/files/Personalized_Medicine_Regulation-Pathways_for_Oversight_of_Dx.pdf
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