Approach to preparing for a biological attack June 2017 Hospital risk management series The debate on critical issues in science, health, and security encompasses many controversies and ethical challenges. The difference between a naturally occurring outbreak and criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled as they come, regardless of the origin of the incident. The post-incident forensic analysis may or may not offer satisfactory answers in regards to attribution, liability, and the responsibility for compensation. The underlying issue for all ethical concerns examined in this work is the balance between individual rights and the needs of public health systems to protect others.

1. Approach to preparing for a biological attack
June 2017
Hospital risk management series
The debate on critical issues in science, health, and security encompasses many
controversies and ethical challenges. The difference between a naturally occurring outbreak and
criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled
as they come, regardless of the origin of the incident. The post-incident forensic analysis may or
may not offer satisfactory answers in regards to attribution, liability, and the responsibility for
compensation. The underlying issue for all ethical concerns examined in this work is the balance
between individual rights and the needs of public health systems to protect others.
The Director of National Intelligence James R Clapper in his Worldwide Threat
Assessment of the U.S. Intelligence Community provided to the Senate Armed Services
Committee (2016) highlighted the danger posed by infectious diseases and their ability to cross-
national and regional boundaries due to globalization and increases in human-animal interactions
resulting from population growth and expansion of human settlements. Increasingly globalized
medical supply chains vulnerable to disruption and uncoordinated international response
compound the issue. At the hospital level, networked medical devices, electronic health records,
and other facets of hospital information systems increasingly affect patient outcomes. At the
same time, healthcare infrastructure became an attractive target for large-scale data theft for both
economic fraud and espionage (Clapper, 2016).
In 2015, the Blue Ribbon Study Panel released a report with the assessment of gaps in the
U.S. biodefense as outlined in the Homeland Security Presidential Directive No. 10 (HSPD-10)
and provided 33 recommendations how to improve the status quo. The key points stressed in the
report relate to the importance of centralized leadership entrusted in the office of the Vice
President of the United States, the creation of a Biodefense Council and a National Biodefense
Strategy, and the ability to improve attribution capability as a condition of successful deterrence.
The integration of animal and human health addresses the fact that many dangerous infections are
zoonoses, and the appreciation for the interaction between environmental, animal, and human
health needs to come from the top leadership. Numerous biological crises already affected the
nation due to a combination of increasingly sophisticated threats, vulnerabilities in the system
itself, and adverse consequences that increase the overall risk. Recommendations span all aspects
of biodefense. The topics range from a notification system on animal health to the funding of
essential programs to biosurveillance capability, medical countermeasures and environmental
decontamination (Blue Ribbon Study Panel on Biodefense, 2015).
In a follow-up report from 2016, the Blue Ribbon Panel stressed that the consequences of
a biological attack would be worse than chemical or radiological. The authors mentioned
documented efforts of terrorist organizations such as al-Qaeda and the Islamic State of Iraq and
Levant (ISIL) to acquire biological weapons, precisely ISIL plan to contaminate water supplies in
Turkey with Francisella tularensis. However, a terrorist attack is not the only concern; accidents,
accidental releases of deadly pathogens, and institutional failures may be another source of
dangerous pathogens. A year later, the Blue Ribbon Study Panel found out that of the 46 items
mentioned in the recommendations section, only two were completed, and some progress was
made in just 17 (Blue Ribbon Study Panel on Biodefense, 2016).

2. The U.S. discontinued the biological warfare program in 1959. Some other countries,
however, still keep their stockpiles and recruit experts. Dr. Parker, former commander of the U.S.
Army Medical Research Institute of Infectious Diseases (USAMRID), stressed the importance of
rapid diagnostics, reliable detection and situational awareness to be embedded in the new
National Biodefense Strategy. While past concerns related to al-Qaeda’s attempts to weaponized
anthrax, this could hardly compare to the current efforts of ISIL that are far more sophisticated
due to better funding and access to educated people. While the traditional biological warfare
agents are still relevant, the possibilities expanded considerably due to biotechnology and
genomics, and the protection of this critical information is essential (House of Representatives
114th Congress 2nd Session, 2016).
Background
The rapid evolution of information systems in healthcare, cross networking of patient
records and medical devices with information support functions affect patient outcomes in ways
never before imagined. The large-scale theft of healthcare data poses a unique risk to the
infrastructure and the patients (Clapper, 2016).
Information protection
The Blue Ribbon Panel on Biodefense recommends the hardening of cybersecurity to
protect pathogen data and biotechnology information from cyber-attacks. Biological information
can be hazardous in the wrong hands, as the gene-sequencing technology is becoming more
accessible. Additional recommendations include the creation of platforms for sharing information
on cyber-threats within the advanced biotechnology communities. The highest-risk platforms
involve data sharing in unsecured clouds and poorly secured data centers, especially in academia.
Particularly risky is the utilization of big data analytics technologies in life sciences and networks
that contain information on pathogen knowledge, and information on genetic sequences of
pathogens and select agents. Such databases then become attractive targets for hackers. The threat
of data compromise needs to become a factor when awarding funding for research in biodefense
(Blue Ribbon Study Panel on Biodefense, 2015).
In 2015, the biggest U.S. health insurance provider Anthem, Inc suffered a massive data
breach that affected 78.8 million patients. The hack was linked to Chinese group Black Vine that
is known for its ties to the Chinese government. Cyber-security firm Symantec in their
postmortem of the incident, concluded that the motivation was not financial but most likely
espionage. However, it is not entirely clear what kind of information were the hackers looking
for. Some suggested that the stolen data can be used in HUMINT operations later on (HIPAA
Journal, 2015).
A data breach of the Office of Personnel Management (OPM) resulted in the compromise
of records of federal employees and sensitive data from clearance forms. According to iSight
Partners Inc., there was a link between the OPM breach and the health insurers’ hacks (HIPAA
Journal, 2015). The incidents were, in fact, two. The first cyber-attack compromised the data of
4.2 million of past and current federal employees. A separate attack resulted in the breach of the
database of background investigations submitted by 21.5 million individuals who submitted their
e-QIP forms when applying for a security clearance. The potential use of this data, apart from
financial cybercrime, includes theft and espionage. While economic crime is pursued through the
criminal justice system, the response to state-sponsored hacker groups involves diplomatic and

3. military means. The OPM breach fell into the category of espionage rather than commercial
activity (Finklea, Christensen, Fischer, Lawrence & Theohary, 2015).
Chinese economy relies heavily on stolen intellectual property. Many industries are
targeted by the Chinese state and contracted hackers, from defense and academic research to
manufacturing, satellite communications, and healthcare. The U.S. economy is exceptionally
dependent on knowledge and intellectual property as the most relevant driver of investment into
new technologies. American healthcare became one of the prime targets of Chinese hackers. The
group that was responsible for hacking multiple insurers such as Anthem, VAE, BlueCross/Blue
Shield and Carefirst, as well as the OPM hacks, is nicknamed Deep Panda, or APT 19, Shell
Crew, Black Vine or Kung Fu Kitten (Scott & Spaniel, 2017).
Dual-use of biotechnology
The risk of occurrence of potentially harmful biological agents or products, intentionally
or not, increases with the advancing research in genome editing and affordability of the
technology. While the editing of human germline remains a significant challenge for scientists,
the creation of recombinant microorganisms and their synthesis de novo is a realistic possibility
(Clapper, 2016).
The development of the Ebola vaccine was a remarkable achievement; however, success
may not be universal. Medical Countermeasures (MCMs), just like tropical diseases, are a small
market segment where significant investment is required to produce substantial innovation and
corresponding results. The MCM research and development function is very risk-averse and
concentrated in small biotechnology firms that have difficulty accessing contracts within the
DOD that are not designed for small businesses. To address the issue, the National Biodefense
Strategy needs to plan for periods between epidemics and such as the national stockpile and not
just for crises (House of Representatives 114th Congress 2nd Session, 2016).
The Blue Ribbon Panel recommends greater sharing of information on threats,
vulnerabilities, and potential consequences with state and local administration, strengthening of
the Joint Counterterrorism Assessment Team (JCAT), and strengthening of the ability of police
units to respond to biological incidents at a local level. The Intelligence Community declassified
some of their findings to be able to share them more effectively with their partners in the
administration at state, local, territorial, and tribal levels. However, institutional prohibitions are
still hard to overcome and often prevent information sharing with emergency services. Also,
fusion centers shall be established to collect and collate information on biological threats from all
relevant sources and share it appropriately (Blue Ribbon Study Panel on Biodefense, 2015).
Making sense of data
China is currently the leading power in genome sequencing. In 2010, Shenzen firm, with
its 128 sequencers, had more than 50% of the total global sequencing capacity. With the
introduction of BGISEC-500, the cost of sequencing the full human genome dropped from
$1.000 in 2010 to close to $200 today. The current share of Chinese sequencers is about 20-30%
of world capacity with a plan to sequence 1.000.000 human genomes in the near future, followed
by the USA (1.000.000 genomes and the U.K. with 100.000 genomes. Chinese National
Genebank houses data on animals, humans, microbes, and plants. Unlike American firms,
Chinese industry can rely on reimbursement from the Chinese health insurance in the future.
(Cyranoski, 2016).

4. Significant computer power is necessary to make sense of information produced in the life
science and biotechnology sectors. According to Top 500, China remains No. 1 on the list of the
world’s most powerful supercomputers. Chinese Sunway TaihuLight that is located in National
Supercomputing Center in Wuxi, ranks No. 1 and Tianhe-2, also called MilkyWay-2, situated in
the National Supercomputing Center in Guangzhou, ranks No. 2. With a total number of 167
supercomputers, China also has the highest number of supercomputing systems in the world,
ahead of the U.S. that has 165 and ranks No. 2. U.S. supercomputing systems Titan, Sequoia,
Mira, and Trinity, rank No. 3, 4, 6, and 7 (Top 500, 2017). In the U.S., the private sector is
primarily responsible for the production and protection of valuable data it produces. However, in
the face of advanced persistent threats sponsored by state actors, this is not a leveled field.
Position –Tread lightly on civil rights
The debate on biodefense encompasses numerous ethical challenges and controversies.
These dilemmas can be reduced to one simple overarching theme: how far shall we go in the
pursuit of public health when the interests of the community and the individual collide? What dod
we do in situations of public health emergencies when individual citizens and private entities
refuse to comply with the presented good ideas voluntarily and challenge them as
unconstitutional?
In August 2016, the Center for Disease Control and Prevention proposed a rule that would
make it easier to deal with public health emergencies, and allow the agency to perform screening
and testing, and to quarantine travelers. Lawyers and health organizations, but also other
professionals such as epidemiologists, raised concerns about the rule’s disregard for due process
and informed consent, lack of time limitation for detention, and the absence of the right to a legal
counsel. A similar effort in 2005 failed due to overwhelming rejection by the public (Yong,
2017).
The debate about federal powers to interfere with civil liberties during public emergencies
needs to strengthen the ability of the U.S. to counter any biological threats without scarifying
civil rights in the process. During the Ebola outbreak, the CDC extensively monitored more than
30.000 travelers and barred them from any public places for three weeks, including public
transport, shopping malls, and the workplace. None of them was infected. Hodge et al. (2017)
argue that any measures implemented have to meet the standard of effectiveness, especially when
it comes to isolation, quarantine, screening, monitoring, travel restrictions, and treatment,
minimum restriction of civil liberties, and be acceptable to the public. The agency also should be
able to prove that any failure to comply increases the risk to others. The main challenges of such
broad-sweeping rules are the right to due process and informed consent (Hodge, Gostin, Parmet,
Nuzzo & Phelan, 2017).
When it comes to emerging infections, the science that supports the diagnostic screening
tests, vaccination schedules, prophylactic, and therapeutic measures is likely to be less than
definitive. Gaps in knowledge result in significant ambiguity about safety, the efficacy of
measures implemented, and the effect on the probability of disease transmission. This uncertainty
means that, to a large degree, many diagnostic, prophylactic, and therapeutic interventions will be
experimental. While the Food and Drug Administration (FDA) allows the use of certain
unapproved products in the case of public health emergencies or on compassionate grounds, there
is no obligation to submit to an experimental treatment.

5. The capability to attribute an attack or accidental release to its source is a significant
deterrent and a driver of implementation of security improvements at facilities that handle
dangerous pathogens. For the victims, attribution can pave the way to eventual compensation in
civil liability and mass tort claims. Microbial forensics is a new scientific discipline that may
allow tracking of a biological agent directly to its source. The Middle East and the North African
region experienced numerous biological threats in the past decade, specifically H1N1, MERS-
CoV, and the use of ricin. However, due to gaps in knowledge, it is easy to misinterpret microbial
forensics evidence as to both a false positive and a false negative (Bidwell & Murch, 2016).
Attribution capability needs to include both scientific and legal components of proof, and
be understandable to the public at large. The Daubert standard of evidence (Daubert v. Merrell
Dow Pharmaceuticals) stands that evidence presented in court needs to be “relevant and rest on a
reliable foundation.” This standard means that the theory or technique has to be tested, and
subject to peer review and publication, must have known potential error rate operational
standards have to exist and must be widely accepted in the scientific community. The evidence
may not always be admissible in common and civil law, under Islamic law or in front of
international tribunals. Solid proof is required for the U.S. Government to be able to persuade
other nations to join military action, impose sanctions, or take a domestic regulatory action. To
conform with the Daubert standard, and to become a useful policy tool, microbial forensics needs
to overcome general suspicions and unrealistic expectations. The perception of the method
suffered due to wrong accusations made in the 2001 Amerithrax and 2015 Mississippi cases. A
review of 156 wrongful convictions all over the United States showed that 60% of these cases
involved invalid forensic testimony coming from 52 forensic labs in 25 states (Bidwell & Bhatt,
2016).
This ambiguity may make it impossible to attribute a biological incident to a malicious
actor or a specific facility responsible for its accidental release. The difference between a
naturally occurring outbreak and criminal act of bioterrorism is likely to be uncertain. As a result,
the grounds for public health emergency may become very shaky if the original narrative proves
to be incorrect. The post-incident forensic analysis may or may not offer satisfactory answers in
regards to attribution, liability, and the responsibility for compensation. Compulsory sharing of
information that may be abused is yet another issue that deserves careful consideration.
Draconian measures based on a narrative that does not pass scientific and legal scrutiny will
likely backfire and further erode public trust.
Counter-Position: Public health approach
When it comes to potentially deadly infections, individual rights end where other people’s
rights begin. The acceptance of screening, prophylactic measures, and treatment at the cost of a
minor personal inconvenience does not need to be questioned as “too much to ask.”
Relevant recommendations by the Blue Ribbon Study Panel regarding the last mile MCM
delivery to patients in need include the need for adequate funding of Public Health Emergency
Preparedness functions, a comprehensive Hospital Preparedness Program, and the preparation of
Clinical Infection Control Guidelines and related training (Blue Ribbon Study Panel on
Biodefense, 2015).
The threat of biological attacks (anthrax), criminal attacks (ricin), and natural outbreaks
such as multidrug-resistant bacteria, Ebola, Zika, H1N1, avian influenza, and re-emerging
diseases overlap. The threat is coming from international terrorist organizations such as al-Qaeda

6. and ISIL, homegrown terrorists, rogue states, effects of climate change, and global connectivity,
but also from technological advances in synthetic biology and gene editing. The BioWatch
Program, implemented by the Office of Health Affairs (OHA) and the Science and Technology
Directorate (S&T) of the Department of Homeland Security (DHS), is an early warning program
against aerosolized biological attack (Department of Homeland Security, 2016). The program
came under scrutiny by the Government Accountability Office (GAO) due to planned upgrades
from Gen-2 to Gen-3. The GAO reviewed the technological capabilities of the Gen-2 system as it
is currently deployed, the testing of the Gen-3 system, and the option of autonomous detection of
biological threats that could eventually replace BioWatch. GAO concluded that the DHS lacks a
reliable assessment of the Gen-2 system that would allow it to make an informed decision on its
cost-effectiveness. While the Gen-2 system needs to be manually administered, the Gen-3
collects airborne particles autonomously and sends the results automatically. False positives
remain a concern, however (U.S. Government Accountability Office, 2015). The stated example
shows that there are controls in place that keep the government’s intrusions into people’s lives in
check and that no error of judgment within the administration goes unpunished.
Interagency body Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE) comprises a list of agencies such as CDC, NIH, FDA, VA, DOD, DHS and USDA
and coordinates the development, acquisition, stockpiling and use of MCMs. Its strategic
implementation plan (SIP) implements the requirements stated in the Public Health Service Act
(Section 2811d) as amended by the Pandemic and All-Hazards Preparedness Reauthorization
Act. MCMs provided through PHEMCE are made available to the public as the need arises.
Special attention is paid to vulnerable populations such as children and pregnant women (U.S.
Department of Health and Human Services, 2017). It is the responsibility of PHEMCE to ensure
the ability to deliver MCMs held in the National Strategic Stockpile to the patients who need
them should a crisis occur (U.S. Department of Health and Human Services, Office of the
Assistant Secretary for Preparedness and Response & Public Health Emergency Medical
Countermeasures Enterprise, 2016).
Conclusions/Recommendations
A balanced approach is essential when asking individuals to comply with any public
health measures that are supposed to protect them, with their consent or not, and people around
them. Any public health emergency that requires significant cooperation from the public needs to
be based on information that is true when it comes to the origin and nature of the threat. The
ability to attribute confidently attacks and accidental releases to the source is essential for the
formulation of an appropriate response. Any restrictions that are imposed on the public need to be
based on rigorous risk assessment and rooted in sound science. Such restrictions have to be
proportionate, appropriate, and acceptable for the public. After all, the condition of a legitimate
government is the consent of the governed. Because of the experimental nature of many new
treatments for emergency use, great caution needs to be exercised when obtaining or waving
consent, as appropriate and relevant. Due process and third party review need to be part of the
emergency isolation process to maintain general public approval of the measures implemented.

7. References
Bidwell, C., & Bhatt, K. (2016). Use of Attribution and Forensic Science in Addressing Biological Weapon
Threats: A Multi - Faceted Study A special report published by the Federation of American
Scientists. federation of American Scientists. Retrieved from https://fas.org/wp-
content/uploads/2016/03/bioattribution-nps-report-3-14.pdf
Bidwell, C., & Murch, R. (2016). Use of Microbial Forensics in the Middle East/North Africa Region An
analysis prepared for the Department of State Bureau of Arms Control and Verification.
Federation of American Scientists. Retrieved from https://fas.org/wp-
content/uploads/2016/03/Vfund-DoS-paper_finaldraft.pdf
Blue Ribbon Study Panel on Biodefense. (2015). A National Blueprint for Biodefense: Leadership and
Major Reform Needed to Optimize Efforts – Bipartisan Report of the Blue Ribbon Study Panel on
Biodefense.. Washington, DC: Hudson Institute. Retrieved from
https://s3.amazonaws.com/media.hudson.org/20151028ANATIONALBLUEPRINTFORBIODEFENSE
.pdf
Blue Ribbon Study Panel on Biodefense. (2016). Biodefense Indicators: One Year Later, Events Outpacing
Efforts to Defend the Nation. Arlington, VA. Retrieved from
www.biodefensestudy.org/LiteratureRetrieve.aspx?ID=144256
Clapper, J. (2016). Statement for the Record Worldwide Threat Assessment of the US Intelligence
Community Senate Armed Services Committee. The U.S. Senate. Retrieved from
https://www.armed-services.senate.gov/imo/media/doc/Clapper_02-09-16.pdf
Cyranoski, D. (2016). China’s bid to be a DNA superpower. Nature, 534(7608), 462-463.
http://dx.doi.org/10.1038/534462a
Department of Homeland Security. (2016). Written testimony of OHA and S&T for a House Homeland
Security Subcommittee on Emergency Preparedness, Response & Communications hearing titled
“Improving the Department of Homeland Security’s Biological Detection and Surveillance
Programs” | Homeland Security. Dhs.gov. Retrieved 10 June 2017, from
https://www.dhs.gov/news/2016/02/11/written-testimony-oha-and-st-house-homeland-
security-subcommittee-emergency
Finklea, K., Christensen, M., Fischer, E., Lawrence, S., & Theohary, C. (2015). Cyber Intrusion into U.S.
Office of Personnel Management: In Brief. Washington D.C.: Congressional Research Service.
Retrieved from https://fas.org/sgp/crs/natsec/R44111.pdf
HIPAA Journal. (2015). Hackers Stole Anthem Data for Espionage; Not Fraud. HIPAA Journal. Retrieved 11
June 2017, from http://www.hipaajournal.com/hackers-stole-anthem-data-for-espionage-not-
fraud-8053/
HIPAA Journal. (2015). OPM 4M-Record Data Theft Linked to Recent HIPAA Data Breaches. HIPAA
Journal. Retrieved 11 June 2017, from http://www.hipaajournal.com/opm-4m-record-data-theft-
linked-to-recent-hipaa-data-breaches-7054/
Hodge, J., Gostin, L., Parmet, W., Nuzzo, J., & Phelan, A. (2017). Federal Powers to Control
Communicable Conditions: Call for Reforms to Assure National Preparedness and Promote
Global Security. Health Security, 15(1), 123-126. http://dx.doi.org/10.1089/hs.2016.0114
House of Representatives 114th Congress 2nd session. (2016). Outside views on biodefense for the
Department of Defense hearing before the Subcommittee on emerging threats and capabilities of

8. the Committee on Armed Services. Washington, D.C.: U.S. Government Printing Office. Retrieved
from https://www.hsdl.org/?view&did=797147
Scott, J., & Spaniel, D. (2017). China's Espionage Dynasty: Economic Death by a Thousand Cuts. Institute
for Critical Infrastructure Technology. Retrieved from http://icitech.org/icit-brief-chinas-
espionage-dynasty-economic-death-by-a-thousand-cuts/
Top 500. (2017). June 2016 | TOP500 Supercomputer Sites. Top500.org. Retrieved 11 June 2017, from
https://www.top500.org/lists/2016/06/
U.S. Government Accountability Office. (2015). Biosurveillance DHS Should Not Pursue BioWatch
Upgrades or Enhancements Until System Capabilities Are Established. U.S. Government
Accountability Office. Retrieved 10 June 2017, from http://www.gao.gov/products/GAO-16-99
U.S. Department of Health and Human Services. (2017). 2016 Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan. U.S. Department of
Health and Human Services. Retrieved from
https://www.phe.gov/Preparedness/mcm/phemce/Documents/2016-phemce-sip.pdf
U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and
Response, & Public Health Emergency Medical Countermeasures Enterprise. (2016). 2016 Public
Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop Report.
Bethesda, MD: U.S. Department of Health and Human Services. Retrieved from
https://www.phe.gov/Preparedness/mcm/phemce/PHEMCEworkshop/Documents/phemce-
stkhldr-wkshp-rpt.pdf
U.S. Department of Health and Human Services, & U.S. Department of Agriculture. (2016). Annual Report
of the Federal Select Agent Program. U.S. Department of Health and Human Services. Retrieved
from https://www.selectagents.gov/resources/FSAP_Annual_Report_2015.pdf
Yong, E. (2017). The CDC’s New Quarantine Rule Could Violate Civil Liberties. The Atlantic. Retrieved 12
June 2017, from https://www.theatlantic.com/science/archive/2016/12/cdc-quarantine-rule-
violate-civil-liberties/511823/

9. Appendix 1: Literature review
Citation Key points
Department of Homeland Security.
(2016). Written testimony of OHA
and S&T for a House Homeland
Security Subcommittee on
Emergency Preparedness, Response
& Communications hearing titled
“Improving the Department of
Homeland Security’s Biological
Detection and Surveillance
Programs” | Homeland Security.
Dhs.gov. Retrieved 10 June 2017,
from
https://www.dhs.gov/news/2016/02
/11/written-testimony-oha-and-st-
house-homeland-security-
subcommittee-emergency
• Threat of biological attacks (anthrax), criminal attacks (ricin) and natural outbreaks (H1N1, avian influenza,
Ebola, Zika, re-emerging diseases) overlap
• Threat: ITO, homegrown terrorists, rogue states; effects of climate change, global connectivity, biotech
advances (synthetic biology, gene editing) and instability in the Middle East
• Increased risk of natural outbreaks (avian influence, multidrug resistant bacteria)
• The DHS Office of Health Affairs (OHA) and the Science and Technology Directorate (S&T) provide intelligence
analysis to other agencies and first responders to improve public health response; and screen incoming
international passengers at five airports.
• Detection and defense: biodetection and biosurveillance programs (the BioWatch Program) and public health
surveillance (the National Biosurveillance Integration Center, NBIC)
• BioWatch Program: early warning against aerosolized biological attack, collective capabilities for all-hazards
response. GAO report suggests BioWatch upgrades and enhancements should not be pursued until the
establishment of system capabilities. Independent tests confirm confidence in the system’s ability
• NBIC: enables early warning of biological events
• S&T (Chemical and Biological Defense Division): medical countermeasures (MCM) acquisition program for the
National Strategic Stockpile, Surveillance, Detection & Diagnostics and Response & Recovery
• The need for Integrated Product Teams (IPTs) on Biological Threat to identify capability gaps in biodefense
U.S. Government Accountability
Office. (2015). Biosurveillance DHS
Should Not Pursue BioWatch
Upgrades or Enhancements Until
System Capabilities Are Established.
U.S. Government Accountability
Office. Retrieved 10 June 2017, from
http://www.gao.gov/products/GAO-
16-99
• BioWatch shall provide early indication of an aerosolized BW attack using Gen-3 detection technology (6 hours
vs. 36 hours) and is exploring technology upgrades of Gen-2. GAO reviewed technical capabilities of the current
BioWatch system as deployed, the Gen-3 testing, and the option of autonomous detection that could replace
BioWatch. GAO recommends not to pursue upgrades for Gen-2 until the current capabilities are established
• Findings: The DHS lacks reliable assessment of the current Gen-2 system necessary to make an informed cost-
effective decision based on the system performance. Effectiveness of the response is uncertain as a result.
• Gen-3 autonomous detection systems collect airborne particles, analyze them and automatically communicate
the results electronically. False positives and security of the network remain a concern.

10. Citation Key points
Bidwell, C., & Murch, R. (2016). Use
of Microbial Forensics in the Middle
East/North Africa Region An analysis
prepared for the Department of
State Bureau of Arms Control and
Verification. Federation of American
Scientists. Retrieved from
https://fas.org/wp-
content/uploads/2016/03/Vfund-
DoS-paper_finaldraft.pdf
• FAS explored the potential of microbial forensic science for the assessment of threats in the Middle East and
North Africa (MENA) region. MENA had to deal with numerous natural and man-made biological threats over
the last decade (H1N1, MERS, Coronavirus, susp. ricin).
• Biological agents do not respect border and religious differences.
• Microbial forensic (MF) evidence can be easily misinterpreted (false positives and false negatives)
• MF can determine the cause, source and perpetrator and support the investigation of suspected acts of
terrorism. MF is still a young science with many gaps in knowledge
• The authors prepared a statement from MENA leaders for a presentation at BW Convention in Geneva
• Impact: developing the next generation of MENA arms controls experts
U.S. Department of Health and
Human Services. (2017). 2016 Public
Health Emergency Medical
Countermeasures Enterprise
(PHEMCE) Strategy and
Implementation Plan. U.S.
Department of Health and Human
Services. Retrieved from
https://www.phe.gov/Preparedness
/mcm/phemce/Documents/2016-
phemce-sip.pdf
• PHEMCE is an interagency body that comprises of CDC, NIH, FDA VA, DOD, DHS and USDA and coordinates the
development, acquisition, stockpiling and use of MCMs.
• Annual PHEMCE strategy and implementation plan (SIP) implements requirements stated in Section 2811(d) of
the Public Health Service (PHS) Act, as amended by the Pandemic and All-Hazards Preparedness
Reauthorization Act (PAHPRA).
• Enhancement of national health security through the acquisition and use of MCMs
• PHEMCE goals: To identify, create, develop, manufacture, and procure critical MCMs, identify clear regulatory
pathways for MCM development and use, develop logistics and operational plans for response, address MCM
use gaps
• Infectious disease outbreaks are a top priority due to transnational nature of the threat, requiring global
response (Zika)
• Threat based approaches – capability development: Anthrax, other bacterial threats, smallpox, pandemic
influenza, Zika, Ebola, MERS-CoV
Blue Ribbon Study Panel on
Biodefense. (2016). Biodefense
Indicators: One Year Later, Events
Outpacing Efforts to Defend the
Nation. Arlington, VA. Health and
Human Services. Retrieved from
www.biodefensestudy.org/Literatur
eRetrieve.aspx?ID=144256
• The consequences of a biological attack would be worse than chemical or radiological
• Documented efforts to acquire BW by al-Qaeda and ISIL (plan to contaminate water supply with Francisella
tularensis in Turkey by ISIL)
• FSAP 2015: 291 labs registered to work with select agents, 233 exposures/releases, lab safety/security
concerns, accidental releases, some even undetected
• 33 recommendations – status of action/inaction. Of the 46 items, there is some progress in 17, only 2
completed (budget appropriation for the National Animal Health Laboratory Network and the Public Health
Emergency Preparedness program)
• Key recommendation: biodefense to become the responsibility of the Vice President (Inaction)

11. Citation Key points
Bidwell, C., & Bhatt, K. (2016). Use of
Attribution and Forensic Science in
Addressing Biological Weapon
Threats: A Multi - Faceted Study A
special report published by the
Federation of American Scientists.
federation of American Scientists.
Retrieved from https://fas.org/wp-
content/uploads/2016/03/bioattribu
tion-nps-report-3-14.pdf
• History, future and challenges of microbial forensics when addressing BW manufacture, acquisition, possession
and use and its role in establishing culpability
• Attribution capability serves as deterrence. The capability includes both scientific and legal proof as well as
public opinion and that of policy leaders
• To be relevant, forensic determinations need to be accepted by other disciplines (public health, LE), the
international science community and the public. A proof provided by microbial forensics and presented by the
USG may not be accepted by world leaders on face value
• Microbial forensics needs to overcome general suspicions and unrealistic expectations
• Wrong accusations: 2001 Amerithrax and 2015 Mississippi cases, the credibility of USG is at stake when
attributing the source. Many foreign governments are not serious enough about countering the BW threat but
understand very well the need for attribution
• Microorganisms require a unique type of database, as sequence similarity or a genotypic match only show
lineage link and not causation – need to be interpreted with caution
• The Daubert standard (Daubert v. Merrell Dow Pharmaceuticals): evidence must be “relevant and rest on a
reliable foundation” (tested theory/technique, subject to peer review and publication, has known potential
error rate, operational standards exist, widespread scientific acceptance)
• Admissibility of evidence in legal systems: common law, civil law, Islamic law and international tribunals
• Civil liability and the role of deterrence: accidental release can make the entity liable for the whole damage if
traceable
• Reports of wrongful convictions due to improper forensics: 2009 NAS report based on 156 wrongful
convictions, of which 60% were due to invalid forensic testimony (72 forensic analysts, 52 labs, 25 states)
• Solid proof (legal, scientific, and universally accepted) required to persuade other nations to join a military
action, take domestic political action, change their behavior, not to interfere with USG military actions, gaining
support for sanctions and other measures, or take domestic regulatory action
• The threat of effective attribution forces security measures at facilities, works well in nuclear forensics, not yet
in BW (see Nuclear Forensics and Attribution Act)
• The science needs to be well understood and universally accepted and trusted to be an effective policy tool

12. Citation Key points
U.S. Department of Health and
Human Services, Office of the
Assistant Secretary for Preparedness
and Response, & Public Health
Emergency Medical
Countermeasures Enterprise. (2016).
2016 Public Health Emergency
Medical Countermeasures Enterprise
Stakeholders Workshop Report.
Bethesda, MD: U.S. Department of
Health and Human Services.
Retrieved from
https://www.phe.gov/Preparedness
/mcm/phemce/PHEMCEworkshop/D
ocuments/phemce-stkhldr-wkshp-
rpt.pdf
• End user considerations: holding MCMs not sufficient – the last mile is important
• Strategic National Stockpile (SNS) – MCMs for which the supply would otherwise be inadequate
• Logistic and supply chain considerations for MCMs (cold supply chain), requires operational live and active
commercial market to function
• PHEMCE MCM Monitoring and Assessment Integrated Program Team (MA IPT) suggested the creation of a
“network of networks” for incident response, and the integration of EHRs in the MCM monitoring efforts
• At risk populations: children, pregnant women, people with disabilities (pediatric dosing models)
• National action plan for combating antibiotic-resistant bacteria (CARB): promoting innovation
• Diagnostic capabilities (chikungunya, MERS-CoV).
• Emerging infectious diseases (EID): Hospital Preparedness Program (HPP) – many conditions under which
hospitals are willing to take in Ebola (and other EID) patients
U.S. Department of Health and
Human Services, & U.S. Department
of Agriculture. (2016). Annual Report
of the Federal Select Agent Program.
U.S. Department of Health and
Human Services. Retrieved from
https://www.selectagents.gov/resou
rces/FSAP_Annual_Report_2015.pdf
• FSAP regulates 291 entities that are authorized to handle special agents (1/3 academic, 1/3 non-federal
government, 1/3 commercial, federal or private).
• 2015: 12 potential losses (all identified as recordkeeping errors, samples mistakenly autoclaved as waste) and
233 potential releases (199 potential occupational exposure)
• DSTA: Francisella tularensis, Yersinia pestis, Bacillus anthracis, Burkholderia pseudomallei, Burkholderia mallei,
Brucella abortus, Brucella melitensis, Brucella suis, botulinum producing species of Clostridium
• AgSAS: Avian influenza virus, Newcastle disease virus, Brucella abortus, Bacillus anthracis, Ralstonia
solanacearum, Xanthomonas oryzae, Brucella melitensis, Brucella suis, Burkholderia pseudomallei, Burkholderia
mallei
• Restricted persons (FBI/CJIS check required) not permitted to have access to these agents (Patriot Act)

13. Citation Key points
Blue Ribbon Study Panel on
Biodefense. (2015). A National
Blueprint for Biodefense: Leadership
and Major Reform Needed to
Optimize Efforts – Bipartisan Report
of the Blue Ribbon Study Panel on
Biodefense.. Washington, DC:
Hudson Institute. Retrieved from
https://s3.amazonaws.com/media.h
udson.org/20151028ANATIONALBLU
EPRINTFORBIODEFENSE.pdf
• The Blue Ribbon Study Panel assessed gaps and provided recommendations on U.S. biodefense
• Biodefense outlined in HSPD 10: Threat awareness (intelligence, assessments, threat anticipation) , prevention
and protection (warning and attribution); response and recovery (planning, mass casualty care, risk
communication, MCM development, decontamination)
• Leadership: no centralized leadership, no strategic plan that would allow control, coordination and
accountability (suggestion: White House – VP). Empower the VP with jurisdiction and authority and budget
authority
• Coordination and accountability: establish centralized leadership – VP and WH Biodefense Council; the need
for appreciation of the links between animal, environmental, and human health; attribution capability; and
decontamination and remediation.
• Broad federal and non-federal stakeholders participation in the Biodefense Council, based on consensus and
accountability
• Collaboration: from local to federal; rapid and accurate identification of a pathogen (biosurveillance capability);
Support for first responders through training and personal protection; support for hospitals (funding of
biodefense programs, incentives); MCM (pre-deployment of stockpiles); securing data
• Innovation: requires prioritization and funding, overhaul the Select Agent Program to facilitate industry
participation
• Numerous biological crises, the combination of numerous threats, vulnerabilities and consequences increased
the risk to the Nation. Major reform is needed.
• National Biodefense Strategy: collate policy, identify requirements/policies/gaps, quadrennial review
• Annual data production, budget analysis, align budget, provide long-term funding
• Congressional oversight
• National Intelligence Manager for Biological Threats
• One Health: nationally notifiable animal disease system (emerging and reemerging diseases)
• MCM: Align investments between civilian MCMs and NIH, funding spend plan
• Attribution: decision-making apparatus, FBI in charge of the National Bioforensics Analysis Center
• Environmental decontamination and remediation strategy (FEMA), studies on exposed individuals
• Biosurveillance capability – National Strategy for Biosurveillance, empower non-federal entities, create
Interagency biosurveillance planning committee, incentivize data sharing
• Appropriate funding for the National Animal Health laboratory, guidance on companion animal and wildlife
zoonoses

14. Citation Key points
Blue Ribbon Study Panel on
Biodefense. (2015). A National
Blueprint for Biodefense: Leadership
and Major Reform Needed to
Optimize Efforts – Bipartisan Report
of the Blue Ribbon Study Panel on
Biodefense.. Washington, DC:
Hudson Institute. Retrieved from
https://s3.amazonaws.com/media.h
udson.org/20151028ANATIONALBLU
EPRINTFORBIODEFENSE.pdf
• Emergency service providers – provide resources, vaccines when requested, medkits, guidelines, protective
equipment so they can protect themselves and their families
• Information sharing: strengthen JCTAT, enable local responders and fusion centers
• Public Health Emergency Preparedness funding
• Clinical infection control guidelines and required training
• Hospital Preparedness Program: minimize redirection of costs, incentivize hospitals to accept patients during
biological events, link CMMS incentives and reimbursements to accreditation standards. Establish a stratified
biodefense hospital system including accreditation
• Disaster preparedness portfolio
• Strategic National Stockpile – logistics, funding, forward deployments
• Harden sensitive information from cyberattacks (pathogen data and advanced biotechnology), tools and incentives
for private entities to do so
• U.S. leadership of the Biological and Toxin Weapons (BTW) Convention
• Military-civilian collaboration for biodefense
• MCM – prioritize innovation over incremental improvement, establish an antigen bank, fund and incentivize
industry and academia
• Reform biomedical advanced research and Development Authority contracting
• Incentivize the development of rapid diagnostic tests usable at point-of-care
• Develop advanced environmental detection systems to replace BioWatch
• Functional and agile global public health apparatus needs to be established.

15. Citation Key points
House of Representatives 114th
Congress 2nd session. (2016).
Outside views on biodefense for the
Department of Defense hearing
before the Subcommittee on
emerging threats and capabilities of
the Committee on Armed Services.
Washington, D.C.: U.S. Government
Printing Office. Retrieved from
https://www.hsdl.org/?view&did=79
7147
• Kenneth L Wainstein (Blue Ribbon Study Panel on Biodefense): Our Report on national biodefense offered 33
recommendations to improve defense against all threats, natural, accidental or malicious. The U.S. discontinued its
BW program in 1969 but many other countries (former USSR) still keep their stockpiles and actively recruit experts.
Intelligence confirms this threat as real and current. The recommendations include the development of a national
biodefense strategy with vision, policy and operational objectives
• Dr Gerald W Parker (Blue Ribbon Study Panel on Biodefense), former commander of USAMRID (U.S. Army Medical
Research Institute of Infectious Diseases): security breaches at Dugway show the risk of institutional failures.
Soldiers are the first to be exposed to new BW agents for which there is no cure. Rapid diagnostics, biodetection
and biosituational awareness are essential. Biodefense doctrine needs to be updated and implemented and tiered
to a new national strategy.
• Past concerns included Al-Qaeda weaponizing anthrax, nowhere near as sophisticated as the current threat of ISIL
that has access to educated people, funding and facilities
• New pathogens can soon be synthesized using information on genetics and proteomics so the ability to protect
this information is critical. Sharing scientific information is a double edge sword
• Strong leadership essential, strategy tied to budget
• Ebola vaccine was ‘a remarkable achievement, in general, MCM R&D is very risk averse. Biodefense, just like
tropical diseases, is no commercial market. DOD contracting business is not great for small business, and that is
where most of the biotech firms are. The need to plan for periods between epidemics (national stockpile), not just
crises
• Traditional BW: anthrax, smallpox, plague, hemorrhagic fevers, botulotoxins are still relevant. However, today,
anything is possible due to biotechnology.
• Recommendations: leadership, strategy, biosurveillance, MCMs, one health (humans and animals – biggest
concerns are zoonoses)

16. Citation Key points
Top 500. (2017). June 2016 | TOP500
Supercomputer Sites. Top500.org.
Retrieved 11 June 2017, from
https://www.top500.org/lists/2016/
06/
• China remains No. 1 on the list of world’s top supercomputers: Sunway TaihuLight (National SuperComputing
center in Wuxi, China) ranks No. 1 and Tianhe-2 or MilkyWay-2 (National SuperComputing center in Guangzhou,
China) ranks No. 2. China has 167 SC systems in total (No. 1)
• U.S. supercomputing systems Titan, Sequoia, Mira and Trinity rank No. 3, 4, 6 and 7. With the total number of 165
supercomputing centers, the U.S. ranks No. 2.
HIPAA Journal. (2017). Hackers Stole
Anthem Data for Espionage; Not
Fraud. HIPAA Journal. Retrieved 11
June 2017, from
http://www.hipaajournal.com/hacke
rs-stole-anthem-data-for-espionage-
not-fraud-8053/
• Symantec concluded that the motivation for the massive data breach that affected 78.8 million clients of health
insurer Anthem, Inc. was espionage rather than financial gain. The hack was linked to Chinese group Black Vine. It
is unclear what information was the group looking for. Some suggested that the HUMINT data will be exploited in
other operations.
HIPAA Journal. (2017). OPM 4M-
Record Data Theft Linked to Recent
HIPAA Data Breaches. HIPAA
Journal. Retrieved 11 June 2017,
from
http://www.hipaajournal.com/opm-
4m-record-data-theft-linked-to-
recent-hipaa-data-breaches-7054/
• The Office of Personnel Management suffered a major data breach of 4 million records of employees including
very sensitive personal information provided for security clearances
• The attack appears to have come from China
• Attacks on health insurers Anthem and Premera Health resulted in unprecedented breaches of 78.8 and 11 million
records, respectively
• iSight Partners, Inc, a cyber-security firm, found a link between the Anthem and Premera and OPM hacks
• exact motivation and target data unclear
Cyranoski, D. (2016). China’s bid to
be a DNA superpower. Nature,
534(7608), 462-463.
http://dx.doi.org/10.1038/534462a
• Since 2010, China ranks No. 1 in DNA sequencing. Shenzen firm BGI purchased 128 sequencers and took the sector
to industrial scale. BGI had more than 50% of the world’s DNA sequencing capacity
• The cost of human genome sequencing dropped to US1.000 (capacity 18.000 full human genomes a year) and will
further drop to about $200 with the introduction of BGISEQ-500 by BGI. Other firms emerged and BGI’s share
dropped (Illumina, X Ten)
• The current share of Chinese sequencers is about 20-30% of world capacity, and increasing, flowed by the UK
(100.000 genomes) and the USA (1.000.000 genomes)
• A plan to sequence 1 million human genomes in China as part of studies of metabolic diseases, and breast and
colon cancer; major advantage – adding diagnostic techniques to national medical insurance list
• Chinese National Genebank houses data on humans, animals, microbes and plants

17. Citation Key points
Finklea, K., Christensen, M., Fischer,
E., Lawrence, S., & Theohary, C.
(2015). Cyber Intrusion into U.S.
Office of Personnel Management: In
Brief. Washington D.C.:
Congressional Research Service.
Retrieved from
https://fas.org/sgp/crs/natsec/R441
11.pdf
• In June 2015, the U.S. Office of Personnel Management suffered a cyberattack that compromised data of 4.2
million current and former USG employees
• A separate incident compromised data of 21.5 million individuals whose records were on the database of
background investigations (e-QIP)
• Potential use of this data includes identity theft, financial cybercrime, espionage
• Response depends on type of threat and motivation: economic crime is pursued via the criminal justice system,
whilst the response to state-actors involves diplomatic and military means. The OPM breach fell into the category
of intelligence gathering rather than commercial activity
• The hack was attributed to China
Scott, J., & Spaniel, D. (2017). China's
Espionage Dynasty: Economic Death
by a Thousand Cuts. Institute for
Critical Infrastructure Technology.
Retrieved from
http://icitech.org/icit-brief-chinas-
espionage-dynasty-economic-death-
by-a-thousand-cuts/
• China’s 13th
Five-Year Plan relies heavily on hacking and technology, data and IP pilfering
• Target: all industries from defense, academic research, manufacturing, materials, sitcom, healthcare
• Objective: to steal, disrupt and cripple the economy
• U.S. currency is backed by ideas that drive the economy, intellectual property is the cornerstone of U.S. economy
• FireEye observed network restructuralization: Third Department consists of state-sponsored ATP groups. The
Military authorized the Ministry of State Security and the Ministry of Public Security to conduct cyber operations.
External groups can be hired for cyber operations also.
• Deep Panda (APT 19, Shell Crew, Black Vine, Kung Fu Kitten) and Axiom are Chinese state-sponsored groups that
have been attacking American (80%) healthcare, aerospace and energy sectors since 2012. The group was also
involved the Office of Personnel Management (OPM) and multiple insurers (Anthem, VAE, Blue Cross/Blue Shield
and Carefirst) hacks. Financial gain is unlikely a concern – more likely the creation of dossiers on specific people
(U.S. and Chinese working for the U.S. government) and monitoring systems.
• Stone Panda is a Chinese APT that has been in operation since 2010. Their targets are healthcare, aerospace,
defense and government organizations.
Clapper, J. (2016). Statement for the
Record Worldwide Threat
Assessment of the US Intelligence
Community Senate Armed Services
Committee. The U.S. Senate.
Retrieved from https://www.armed-
services.senate.gov/imo/media/doc/
Clapper_02-09-16.pdf
• Infrastructure: networking of medical devices, EHR, hospital networks influences patient outcomes. Critical supply
chains are international; healthcare data subject to large-scale theft
• Genome editing research is a dual-use technology that may result in potentially harmful biological agents
• The combination of infectious diseases and the global MCM vulnerable to disruptions will continue to be a
challenge to U.S. security. Globalization facilitates the spread of infections across regions.
• Increasing animal-human interactions are a major risk, especially clearing new land urbanization
• Current threats: Zika, MERS, influenza, hemorrhagic fevers (Ebola)
• Lack of international coordinated response to outbreaks in regards to surveillance, response, information sharing

18. Citation Key points
Hodge, J., Gostin, L., Parmet, W.,
Nuzzo, J., & Phelan, A. (2017).
Federal Powers to Control
Communicable Conditions: Call for
Reforms to Assure National
Preparedness and Promote Global
Security. Health Security, 15(1), 123-
126.
http://dx.doi.org/10.1089/hs.2016.0
114
• During the Ebola outbreak, more than 30.000 travellers were identified as potentially exposed and were
monitored for up to 3 weeks, and barred from public places including public transport and work. None of these
people was infected so the exercise may seem as unnecessary
• Any measures implemented have to meet standards of effectiveness (quarantine, isolation, travel restrictions,
screening, monitoring, treatment), minimum restriction of public liberties, and publicly acceptable. The agency
should be able to prove that failure to comply with these measures increases the risk to others.
• Due process requires a neutral decision maker other than the agency itself
• Vaccination and treatment require informed consent – mere suspicion is insufficient to override this right
Yong, E. (2017). The CDC’s New
Quarantine Rule Could Violate Civil
Liberties. The Atlantic. Retrieved 12
June 2017, from
https://www.theatlantic.com/scienc
e/archive/2016/12/cdc-quarantine-
rule-violate-civil-liberties/511823/
• The CDC proposed a rule that would make it easier to deal with outbreaks and aloow it to screen, test and
quarantine travelers during public health emergencies
• Lawyers and health organizations, but also epidemiologists, raised concerns about due process and informed
consent
• Similar effort in 2005 failed following an avalanche of critical comments
• The right to detain people at airports who appear seriously ill already exists (Ebola, plague, smallpox)
• Reason: flexible and expedient approach for unpredictable situations
• The proposed rule cannot withstand constitutional scrutiny
• Due process – no right to legal counsel, no time limitation