William “Will” So, Ph.D.

Policy & Program Specialist

Federal Bureau of Investigation – Headquarters

Weapons of Mass Destruction Directorate

Biological Countermeasures Unit 15 November 2016

EMERGING RISKS RELATED TO

BIOTECHNOLOGYA CASE STUDY OF CURRENT AND FUTURE

CHALLENGES TO CYBERSECURITY, THE

ECONOMY, AND HEALTH

FBI WMD Directorate

• In 2006, FBI consolidated its investigation,

intelligence and prevention efforts into one HQ

Division, the WMD Directorate Centralized

structure affords a more cohesive and

coordinated approach to incidents involving

WMD; focus on prevention.FBI Headquarters (Washington, DC)

• FBI WMD Directorate actively engaged in building capacities by

developing national-level policy, guidance, and countermeasures

to prevent, detect, disrupt, and respond to WMD.

• WMD Directorate taps into the tactical and technical expertise of

other FBI operational and support divisions, embedding

personnel in these components as needed and coordinating

investigations and initiatives.

18 USC 175(a)

Crime to knowingly possess a biological agent, toxin, or delivery

system for use as weapon establishes BWC/UNSCR 1540

violations as crime

18 USC 175(b)Crime to knowingly possess a biological agent, toxin, or delivery

system if not for peaceful research purposes

18 USC 175b Crime to knowingly possess select agent, regardless of intent, if

not registered with U.S. Federal Select Agent Program

18 USC 175c Crime to produce, engineer, or synthesize smallpox

18 USC 806 Enhances ability to seize assets of those with WMD intent

18 USC 842 Crime to teach or demonstrate the making or use of a WMD

18 USC 2332a Crime to use (or conspire, threaten, or attempt to use) a WMD

Biological crimes

WMD crimes

United States Federal Laws

Title 18 United States Criminal Code (Crimes)

DNA Sequencing Perspective

Human Genome Project

13 Years, 3 Billion USD1990 – 2000

2008~1 Month, <100,000 USD

TodayLife Technologies Introduces the

Benchtop Ion ProtonTM Sequencer

Designed to Decode a Human Genome in

1 Day, 1000 USD

http://www.telegraph.co.uk/finance/newsbysector/mediatechnologyandte

lecoms/electronics/10540860/Fitbit-in-push-to-lead-the-wearable-tech-

boom.html

http://lsi.ubc.ca/our-vision/personalized-medicine/projects/

“Precision”

“Personalized” Medicine

BGI Is Granted Patent In 16 Countries For Non-

invasive Prenatal Genetic Test Technology

October 10, 2014, Shenzhen, China-- The European Patent Office has issued

patent number for invention to BGI for its independently researched non-invasive

prenatal genetic test (NIPT) technology. The patent is effective in 15 member

countries including England, Belgium, Spain, Slovenia, Hungary, Sweden, Turkey,

Switzerland, Italy, France, Denmark, Germany, Czech Republic, Poland and

Romania

As of August, 2014, BGI Dx, a subsidiary unit of BGI, has provided

non-invasive prenatal genetic testing services via its NIFTY® test to

nearly 400,000 pregnant women worldwide.

http://www.eurekalert.org/pub_releases/2014-10/bs-big101014.php

Affordable and Convenient

23andMe Pulls Off Massive

Crowdsourced Depression Study

A scientific expedition into the DNA of

more than 450,000 customers of gene-

testing company 23andMe has

uncovered the first major trove of

genetic clues to the cause of

depression.

The study, the largest of its kind,

detected 15 regions of human genome

linked to a higher risk of struggling with

serious depression.

•by Antonio Regalado

•August 1, 2016

https://www.technologyreview.com/s/602052/23andme-pulls-off-massive-crowdsourced-depression-study/

Your medical record is worth more to

hackers than your credit card

By Caroline Humer and Jim Finkle, Sep. 24, 2014

The FBI warned healthcare providers to

guard against cyber attacks after one of

the largest U.S. hospital operators,

Community Health Systems Inc, said

hackers had broken into its computer

network and stolen the personal

information of 4.5 million patients.

http://news.yahoo.com/medical-record-worth-more-hackers-credit-card-

182251915--finance.html

Premera hack: What criminals can do

with your healthcare data

http://www.csmonitor.com/World/Passcode/2015/0320/Premera-hack-What-criminals-can-do-with-your-

healthcare-data

Hackers penetrated Premera Blue Cross

and made off with the kind of information

that can be far more devastating than any

digital bank heist.

Culprits behind the Premera hack were

able to collect that kind of information on

11 million of its current and former

members

It seems that whoever intruded into Premera's network may have been inside

its system for nearly a year, siphoning off the type of clinical data that

security analysts say can provide crooks with virtually every single data

element needed to clone someone’s identity.

This event brought together

scientists across a range of

disciplines, security

professionals, and science

and security policy experts to

explore ways to leverage the

beneficial applications and

identify potential risks of big

data and analytics to

biological security.

http://www.aaas.org/cstsp/bigdata

Joint FBI/AAAS/UNICRI Report on Big Data in

the Life Sciences Illuminates Challenges, Risks

and Rewards 10 November 2014, Kat Zambon

• Data veracity, provenance

• Personal health data security

• Not just PII/financial data

• Clinical trials/drug studies

• IRB challenges with protecting identity

(de-anonymization)

• Personal health data protection (e.g.

“opting out”, extortion, exploitation)

• Informed consent

• Addressing security in an “open”

environment

www.aaas.org/report/national-and-transnational-security-implications-big-data-life-

sciences

Future Challenges

THANK YOU