Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016. This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S. The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich. Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.

1. BIG DATA NEGLECTS
POPULATIONS MOST
IN NEED OF MEDICAL
AND PUBLIC HEALTH
RESEARCH AND
INTERVENTIONS
Sarah E. Malanga, JD/MPH

2. Overview • Big Data
• Uses in medicine
• Gaps in collection of Big Data
• Consequences
• Recommendations

3. Source: http://www.ibmbigdatahub.com/infographic/four-vs-big-data

4. Source: https://datafloq.com/read/understanding-sources-big-data-infographic/338

5. How is Big
Data used in
medicine?
• Recruitment
• Study design
• Public health intervention design &
implementation
• Precision medicine
• Prescription drug usage trends
• Population genetics

6. Gaps in Data
Collection
Unfortunately, Big Data is not always inclusive…
20%
57%
19.9% 11.8%
9.3%
30%

7. BIG DATA SOURCE HOW IT’S USED GAPS IN COLLECTION
Social Media ( i.e. Facebook,
Twitter);
Wearables (i.e., Apple Watch,
FitBit);
Internet Use
Consumer trends, behavioral
data, and biometrics
Not everyone has access to social
media, wearables, or the internet;
not everyone chooses to engage
with social media or use a
wearable
Electronic Health Records;
Insurance Claims
Gathering and analyzing data on
a range of medical and
healthcare issues – disease
prevalence, diagnoses,
prescription drug trends
Certain hospitals/healthcare
facilities may not use EMRs,
therefore creating a dearth of
information on certain
demographics
Genome Sequencing;
Biospecimens;
Research Participation
Ability to collect and analyze
genetic information
Cost prohibitive; emphasis on
collecting from certain
populations

8. Consequences
The exclusivity of big data is troublesome because of
its potential ramifications in terms of national
health.

9. Dearth of
information
Heightened
risk of health
disparity
Lack of
tailored
health care
Less benefits
for certain
populations

10. Recommendations
Use Precision Medicine Initiative funding to
increase grants focused on diverse
populations
Encourage the FDA to require that data from
a diverse, inclusive pool
Continuously update recommendations &
guidelines
Encourage new regulations to guarantee
inclusive data
The Precision Medicine Initiative provides
$215 in funding to encourage investment and
research into precision medicine
FDA guidelines suggest mechanisms on how
to collect racial and ethnic data
Various agencies provide guidelines and
recommendations to increase diversity
Federal government is currently involved in
the regulation of scientific endeavors

11. BIG DATA SOURCE WHAT’S CURRENTLY BEING
DONE TO ADDRESS GAPS?
RECOMMENDATION
Social Media ( i.e. Facebook,
Twitter);
Wearables (i.e., Apple Watch,
FitBit);
Internet Use
Lifeline was expanded in March
2016 to include broadband
services, which will be available to
low-income Americans.
Expand Lifeline program to
provide smartphones and mobile
internet
Electronic Health Records;
Insurance Claims
HITECH Initiative;
Affordable Care Act;
Medicaid expansion
Utilize EHRs in a more diverse,
representative manner – expand
their use across the country, with
focus on populations that are not
currently receiving adequate
representation
Genome Sequencing;
Biospecimens;
Research Participation
NIH policy;
FDA guidelines
FDA should make diversity
guidelines mandatory and
enforce data standards in the
research it will in the approval
process

12. Questions?

13. Thank you!