Protecting U.S. Genomic Data after the CHIPS Plus Science Act

Photo by Sangharsh Lohakare on Unsplash

By Hershel Tamboli

On August 9, 2022, President Biden signed the CHIPS Plus Science Act (CHIPS Act) into law. The act is the United States’ first industrial policy to revitalize domestic scientific research enterprise and technological innovation capabilities. Its primary objectives are to help the United States maintain global economic competitiveness and reduce dependence on strategic rivals, namely China. These objectives are not entirely unprecedented. The U.S. government has previously mobilized science to meet strategic objectives during World War II and the Cold War, but the scale and scope of the CHIPS Act are novel. Although the act is best known for a $52 billion investment in semiconductor manufacturing, it is also dedicated to research and innovation. It includes a section on the bioeconomy, defined as “economic activity that is driven by research and innovation in the life sciences and biotechnology…enabled by technological advances in engineering and in computing and information sciences.”[1] This section aims to expand the field of genomics, or the study of the human genome, by developing a genomic sequencing strategy and building robust databases. The act thus places genomics at the forefront of the United States’ bioeconomic strategy.[2]

Given the act’s geopolitical motivations, the economic and national security risks of the United States sharing its genomic data with China without restrictions or reciprocity are worth examining. While investments in the U.S. bioeconomy are necessary, they will also increase the volume of this sensitive information, which an adversary could use to monopolize pharmaceutical products and exploit genetic vulnerabilities. The nature of military-civil fusion in China amplifies those concerns, especially as Chinese research institutions and genomics firms operating internationally can have obscured ties to the Chinese government or the People’s Liberation Army (PLA). Without proper oversight of our genomic data, the United States remains handicapped in its technological competition with China.

The CHIPS Act requires supporting measures to prevent backfiring. Although President Biden issued Executive Order 14081 on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy in September 2022, it does not address the vulnerability of genomic data.[3] However, China’s commitment to becoming the global leader in biotechnology will not materialize without access to forthcoming, high-quality U.S. genomic databases, so there is still time to act. Bearing in mind this data's role in U.S.-China technology competition, the United States can adopt several policies that restrict China’s access while driving innovation in the bioeconomy. If implemented before the act’s investments peak, these policies will protect U.S. economic competitiveness and national security as bioeconomic activity increases. This article will first examine the strategic role of genomic data in U.S.-China competition, particularly in creating vulnerabilities for the former. It will then turn to some potential approaches to the problem and explain why they are undesirable. Lastly, it will provide a set of viable policy recommendations to secure future U.S. innovation in biotechnology.
The Role of Genomic Data in U.S.-China Competition 

Technological competition between the United States and China demands state investment in developing and deploying critical technologies in multiple disciplines. As computing and information science combine with biotechnology, genomic data has unsurprisingly become a key input of the bioeconomy. 

The lack of data reciprocity makes the United States vulnerable. 

A strategic weakness for the United States is the lack of reciprocity from China and of U.S. government control over Americans’ genomic data. Genomic sequencing data has advantages, such as providing further insight into disease trends and driving advances in precision medicine.[4] For example, data from the 23andMe sequencing service has been used to identify genetic markers associated with clinical depression.[5] However, current data flows are one-sided: Chinese organizations obtain U.S. genomic data through research collaborations, business transactions that force data transfer in exchange for market access, and acquisitions of U.S. firms that hold such data. The Chinese government can then invoke its National Security Law and National Intelligence Law to compel recipient organizations to turn over that data.[6] Yet, China simultaneously restricts the export of its genomic data and only grants access to U.S. firms if they collaborate with Chinese entities and receive government approval.[7] China’s Medium- and Long-Term plan identifies biotechnology as a key frontier, and its scientific “megaprojects” include related topics such as genetic engineering.[8] The United States has no equivalent laws and, until recently, had no equivalent investment plan. In other words, the United States shares critical data about its population with a strategic competitor without much protection and without demanding the same in return. 

China could use U.S. data to harm competitiveness and exploit genetic vulnerabilities.

Poor oversight of U.S. genomic data creates both economic and national security threats. Access to datasets from both countries would give Chinese researchers a significant advantage over their U.S. counterparts in the market for precision medicine, which refers to medical treatments individually tailored to a person based on their genetic characteristics.[9] Given the U.S. population’s racial and ethnic diversity, its genomic data is more useful for precision medicine than genomic data from China’s comparatively homogeneous population. Chinese pharmaceutical firms could use these insights to outcompete U.S. rivals and monopolize the precision medicine market. The genomic data problem could also lead to the exploitation of genetic vulnerabilities and the targeting of entire populations through biological weapons, especially in the era of made-to-order pathogens. Knowledge of an individual’s predispositions or risks of disease could be used to harm particular individuals or even entire subsets of the U.S. population.[10] It could even theoretically lead to genetically engineered soldiers who can survive in conditions that U.S. combatants could not.[11] If the Chinese Communist Party (CCP) can use genomic data to surveil and discriminate against Uyghur minorities at home, it is capable of doing the same to foreign adversaries.[12]

Given China’s military-civil fusion, commercial activities involving genomics exacerbates these concerns. WuXi Healthcare and genomics giant BGI Group (formerly Beijing Genomics Institute) have partnered with Huawei Technologies, known to be controlled by the PLA, to develop extensive data storage systems for genomic research.[13] WuXi’s collaboration with Huawei explicitly supports the Chinese government’s Precision Medicine Initiative, which dwarfs the U.S. equivalent by comparison.[14] BGI collected data from pregnant women in fifty-two countries through a prenatal test developed in collaboration with the Chinese military, and used it to further surveil women and ethnic minorities.[15] Meanwhile, BGI subsidiary MGI has made its DNA sequencing devices commercially available in the United States as of August 2022.[16] China’s push toward domestic bioinformatics (applying computation and analysis to biological data), coupled with the global expansion of lower-cost sequencing services and equipment, is part of a geopolitical strategy for which genomic data is essential. 

The CHIPS Act could make matters worse without attention to genomic data.  

The CHIPS Act’s bioeconomic provisions could be counterproductive unless they prioritize the control and reciprocity of genomic data. By establishing the National Engineering Biology Research and Development Initiative, the act addresses a longstanding concern over the neglect of the bioeconomy. Notably, it also calls for creating genomics databases and coordinating a national genetic sequencing strategy. It does not, however, specifically address the economic and national security risks of genomic data sharing; new laws are limited to the “development of standards for such databases, including…privacy and security.”[17] Large-scale bioeconomic investments will likely produce more sequencing projects, genetic research collaborations, and volumes of data. Without attention to the protection of that data, those investments will only exacerbate the problem by increasing the data available to China.  

While this article primarily responds to the CHIPS Act, it is worth noting that President Biden’s subsequent Executive Order (EO) on Advancing Biotechnology and Biomanufacturing Innovation is more robust. It includes an explicit commitment to safeguarding the bioeconomy from foreign adversaries and establishes a Data for the Bioeconomy Initiative to develop sophisticated and secure biological datasets.[18] Under the EO, the Office of the Director of National Intelligence is charged with assessing risks to the U.S. bioeconomy, after which the Assistant to the President for National Security Affairs (APNSA) will coordinate and finalize a plan to mitigate those risks. Yet the EO still calls for “the open sharing of…genetic sequence data, to the greatest extent possible in accordance with applicable law and policy.”[19] That last phrase is the most notable, as current laws and policies provide insufficient protection. If data sharing continues to be free-flowing and one-sided, the EO will be less effective. 

Flawed Approaches to Managing the Problem

Share genomic data openly only in accordance with current law.

The default option for the United States would be to implement no additional measures beyond the language of the CHIPS Act and subsequent EO. The act calls for genomic databases to be secured. The EO expands on that requirement while encouraging genomic data sharing to the extent allowable by “applicable law and policy.” Existing health regulations and export controls offer some protection but are limited in scope. While the Health Insurance Portability and Accountability Act (HIPAA) requires covered entities (i.e. the healthcare sector) to protect genomic data, it does not apply to consumer services like 23andMe.[20] Export controls would not apply to fundamental research involving genomic data. Even if they did, their level of control would likely be so low that sharing with China would generally not require government authorization unless the recipient were explicitly on a restricted list.[21] The U.S. does not have a uniform data privacy law, and the Genetic Information Nondiscrimination Act (GINA) is concerned with insurance providers and employers, not foreign entities.[22] It would thus be unwise to encourage sharing genomic data without laws that specifically consider the economic and national security threats from China’s use of it. 

Obtain Chinese data through surreptitious means. 

 To level the playing field, the United States could attempt to mine Chinese genomic data in retaliation. It could promote its sequencing equipment and services in China and increase the number of genomic research collaborations. It could also conduct cyberattacks on China’s vast genomic databases. These tactics may help the United States recover ground and signal to China that it is prepared to play the same game. But such an approach would prove both impractical and dangerous. China provides sequencing equipment and services at far lower costs than the United States does. Even if CHIPS Act investments in the bioeconomy lead to cost savings, China’s laws would still prevent U.S. entities’ access to its data. Cyberattacks would be costly and yield nothing close to Chinese stores of U.S. data. News of cyberattacks would escalate tensions and invite China to retaliate. It would also raise questions with allies regarding the integrity of U.S. research. Any short-term benefit would not outweigh the costs. 

Encourage data sharing with China for public health reasons. 

The United States could allow genomic data sharing to continue in the interest of public health. China already undercuts the United States in drug prices, so allowing it to use genomic data for precision medicine could benefit future generations with access to affordable, tailored therapies.[23] As the United States creates more sophisticated genomic databases, it could share them with China so better data can lead to better medicine. This may seem appealing from a purely public health perspective, but it is naïve. The U.S. relies heavily on China—a strategic competitor—for pharmaceutical products and drugs.[24] Should conflict escalate to war, the United States would be medically dependent on the enemy. China’s lack of transparency in the public health domain also makes this approach untenable. The WHO launched an investigation into the origins of COVID-19 in 2021 but was forced to abandon it two years later after China’s refusal to provide the information requested by investigators.[25] If China cannot collaborate in a pandemic, it will not do so in less pressing times. China cannot be considered a reliable partner in public health. 

Recommended Policies for Protecting U.S. Genomic Data 

Amend and pass the GENE Act and Genomics Data Security Act. 

Congress should pass the Genomics Expenditures and National Security Enhancement (GENE) Act and the Genomics Data Security Act, both introduced in May 2021 but not yet law. The former would require mandatory filing with the Committee on Foreign Investment in the United States (CFIUS) for transactions involving genetic information. At the same time, the latter would prohibit the National Institutes of Health from providing genomic sequencing services to any Chinese entity.[26] Prior to finalizing the bills, Congress should work with the scientific community and CFIUS to determine the exact criteria for filing, as every single instance of research involving genomic data may not pose an issue. The acts should also be amended to include the following provisions:

• Require that a U.S. entity be involved in any transaction or collaboration where U.S. genomic data will be released to a Chinese entity;  

• Require sequencing providers to disclose to customers whether they share genomic data with foreign entities; and

• Require sequencing providers to report Chinese affiliations to Congress. 

Restrict procurement of BGI/MGI sequencing services and devices under the FY23 National Defense Authorization Act.

Congress should prohibit the U.S. government and its contractors from using BGI services and equipment, including DNA sequencers manufactured by its subsidiary MGI that promise high quality and accuracy.[27] The National Defense Authorization Act (NDAA) already prohibits government procurement of telecommunications equipment manufactured by Chinese companies doing the bidding of the CCP and PLA, including BGI partner Huawei.[28] Following this precedent, U.S. government labs and research institutions that receive federal funding should not be permitted to use sequencing services or devices from BGI. Other Chinese firms should be added to the new NDAA list as needed. Some portion of the CHIPS Act’s bioeconomy funds should be used to subsidize the cost of substitutes if required.  

Require indication of genomic data in federally funded research proposals.

U.S. federal funding agencies should require award applicants to plainly indicate whether genomic data will be disclosed to a foreign entity and in what form (e.g., with identifying information removed). The agency can use that information to conduct pre-award risk assessments as the CHIPS Act requires. If a Chinese entity is present, the funding agency can efficiently refer the case to CFIUS as required by the GENE Act. Funding agencies can also use this information to identify research institutions with high volumes of genomic research and include relevant content in their research security outreach. 

Prioritize therapies for which the United States is dependent on China. 

China already has access to U.S. genomic data and will continue to extract it until adequate measures are implemented. Therefore, it may already have enough data to begin developing precision drugs tailored to the U.S. population while the United States itself struggles to bolster domestic manufacturing. To compensate for lost time, Congress should establish a Federal Advisory Committee comprising defense leaders, epidemiologists, and pharmaceutical stakeholders to identify vulnerabilities in the national supply of medicine and compile a list of pharmaceutical products for which the United States is mostly or entirely dependent on China. Special focus should be on two groups of items: those the U.S. military procures from China and those for which a shortage would create a public health emergency. CHIPS Act funds should be allocated to increasing research, enhancing manufacturing capacity, and subsidizing costs to meet demand and recapture market share. 

Create avenues for export controls to apply where needed. 

Funding sponsors should establish requirements for disseminating U.S. genomic data to foreign countries, thereby making genomic data subject to U.S. export control laws. The U.S. Department of Commerce should also monitor public and private actors in China’s genomic research sectors and add entities of concern to its restricted party lists. Under current law, research intended to be freely published is exempt from export control.[29] But if genomic research became subject to even the lowest level of export control, the data would require government authorization, or at least additional assurance from the recipient, before being shared with a member of a restricted list. The Department of Commerce added BGI to its Entity List of actors of national security or foreign policy concern in March 2023.[30] These restrictions, however, are only applicable when the federal research sponsor, such as the National Science Foundation or the Department of Defense, imposes publication conditions like keeping some results confidential. As such, the Department of Commerce and funding agencies must coordinate proactively. 

Conclusion

Genomic data will play a key role in the next phase of the U.S.-China technological competition. While the CHIPS Act’s investments in the bioeconomy are promising, the United States still needs to increase oversight of its genomic data to prevent China from using it to undermine U.S. economic and national security. The United States can address those concerns by adopting the recommended policies, leaving China struggling to secure a competitive advantage without access to such data or a pharmaceutical monopoly. These policies will depend not only on funding but also on informed legislation. They are part of broader conversations on the United States decoupling from China in key industries and increasing regulation of academia — efforts that are underway but likely to clash with arguments of economic benefits and academic freedom. 

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About the Author

Hershel Tamboli is a student in the Master of Science in Foreign Service program at Georgetown University, where he focuses on emerging technologies and national security. He was previously a consultant specializing in export controls and sanctions compliance and most recently served as the assistant director of export control at Emory University, where he helped stand up the university’s export control and research security programs. 

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Endnotes

1. Safeguarding the Bioeconomy. National Academies Press EBooks. National Academies Press, 2020. https://doi.org/10.17226/25525. 

2. U.S. Congress, House, CHIPS PLUS SCIENCE and Science Act of 2022, HR 4346, 117th Congress., 2nd sess., https://www.commerce.senate.gov/services/files/CFC99CC6-CE84-4B1A-8BBF-8D2E84BD7965.

3. Joseph R. Biden, “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” The White House, September 12, 2022, https://www.whitehouse.gov/briefing-room/presidential-actions/2022/09/12/executive-order-on-advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american-bioeconomy/.

4. “Pursuing Precision Medicine | NIH Intramural Research Program,” Jan 12, 2022. https://irp.nih.gov/our-research/accelerating-science/pursuing-precision-medicine.

5. Safeguarding the Bioeconomy, 292.

6. William C. Hannas, Didi Kirsten Tatlow, and Jeffrey Stoff, “Sino-Foreign Research Collaboration,” China's Quest for Foreign Technology: Beyond Espionage. (London: Routledge Taylor & Francis Group, 2021), pp. 169-180.

7.  Safeguarding the Bioeconomy, 293.

8. National Research Council, “China's Medium- and Long-Term Plan.” Washington, DC: National Academies Press. https://nap.nationalacademies.org/read/13472/chapter/16. 

9. Safeguarding the Bioeconomy, 298.

10. Ibid, 297-8. 

11. Kirsty Needham and Clare Baldwin, “China's Gene Giant Harvests Data from Millions of Pregnant Women,” Reuters (Thomson Reuters, July 7, 2021), https://www.reuters.com/investigates/special-report/health-china-bgi-dna/. 

12. The National Counterintelligence and Security Center, “China’s Collection of Genomic and Other Healthcare Data From America: Risks to Privacy and U.S. Economic and National Security,” February 2021, https://www.dni.gov/files/NCSC/documents/SafeguardingOurFuture/NCSC_China_Genomics_Fact_Sheet_2021revision20210203.pdf. 

13. Ed You, “Safeguarding the Bioeconomy: Amazing Promise, Emerging Challenges” (2020), https://ncvhs.hhs.gov/wp-content/uploads/2020/04/Q-Ed-You-Safeguarding-the-Bioeconomy_508.pdf.

14. Ibid. 

15. Needham and Baldwin.

16. MGI Tech Co. Ltd., “MGI Announces Commercial Availability of DNBSEQ™ Sequencers in the United States,” June 6, 2022, https://www.prnewswire.com/news-releases/mgi-announces-commercial-availability-of-dnbseq-sequencers-in-the-united-states-301562003.html. 

17. U.S. Congress, House, CHIPS PLUS SCIENCE and Science Act of 2022.  

18. Joseph R. Biden, “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” 

19. Ibid.

20. George Davidson, “Is 23andMe HIPAA Compliant?” Jotform HIPAA Compliance Checker, September 28, 2022. https://www.jotform.com/hipaa/is-hipaa-compliant/23andme/. 

21. Lawrence Berkeley National Laboratory, “Export Terminology & Definitions,” https://exportcontrol.lbl.gov/glossary/. 

22. U.S. Congress, House, Genetic Information Nondiscrimination Act of 2008, H.R. 493, 110th Congress, introduced in House January 16, 2007, https://www.congress.gov/bill/110th-congress/house-bill/493/text. 

23. Rosemary Gibson and Janardan Prasad Singh, China RX: Exposing the Risks of America's Dependence on China for Medicine (Amherst: Prometheus Books, 2021), pp. 94.

24. Ibid, 10.

25. Mallapaty, Smriti. “WHO Abandons Plans for Crucial Second Phase of COVID-Origins Investigation.” Nature, February 14, 2023. https://doi.org/10.1038/d41586-023-00283-y. 

26. U.S. Congress, Senate, Genomics Expenditures and National Security Enhancement Act of 2021, S. 1745, 117th Congress, 1st sess., introduced in Senate May 20, 2021, https://www.congress.gov/bill/117th-congress/senate-bill/1745/text?r=15; U.S. Congress, Senate, Genomics Data Security Act, S. 1744, 117th Congress, 1st sess., introduced in Senate May 20, 2021, https://www.congress.gov/bill/117th-congress/senate-bill/1744/text/. 

27. “DNBSEQ-G400 High-Throughput Sequencing Set-MGI-Leading Life Science Innovation.” n.d. MGI, https://en.mgi-tech.com/products/reagents_info/20/.

28. General Services Administration, “Section 889 Policies,” Acquisition.gov, https://www.acquisition.gov/Section-889-Policies. 

29. ““Technology” or “software” that arises during, or results from, fundamental research.” Code of Federal Regulations, Title 15 § 734.8, June 3, 2016.

30. Bureau of Industry and Security, Department of Commerce. "Additions and Revisions of Entities to the Entity List," Federal Register Vol. 88, no. 43, March 3, 2023, pp. 13673. https://www.govinfo.gov/content/pkg/FR-2023-03-06/pdf/2023-04558.pdf.