The New Normal: Mass Temperature Screening and the Law
Written by: Michael Walsh
Disclaimer: This post does not contain legal advice. I am not a licensed attorney nor am I qualified to give compliance help or other legal services. This post is for educational purposes only.
Due to a resurgence of the COVID-19 pandemic in many states, federal and state health agencies have deployed several technologies to help track (and ultimately quell) the spread of the pandemic. Temperature scans and other screening technologies have become commonplace, and nonconsensual mass temperature screening has been used to mitigate the spread of other major pandemics in the past.[1] The Food and Drug Administration (FDA) issued comprehensive, but nonbinding guidance on the use of thermal imaging technologies for COVID diagnostics, which advocates for the use of thermal imaging tech as an initial screening tool in “high throughput areas” such as airports, businesses and other high density areas where traditional temperature measuring techniques would be ineffective or impracticable.[2]
Technical Limitations and Efficacy of Temperature Screening
Some scientific studies support the use of telethermographic devices or non-contact infrared thermometers (NCITs) to accurately measure skin temperature (which correlates with core temperature).[3] NCITs are thermal imaging systems that measure infrared radiation that is omitted from febrile humans (humans with a detectable fever) and convert that radiation map into a relative temperature measurement.[4] However, the FDA emphasizes that such technologies are not suitable as a sole means of diagnosing COVID-19.[5]
NCITs can be effective at sensing relative temperatures but have palpable limitations that can affect the technology’s efficacy. The American Civil Liberties Union (ACLU), citing a clinical study of NCITs, asserts that mass screening of open rooms can lead to wildly inaccurate temperature measurements.[6] The FDA recommends that temperature scans should be made in highly controlled environments or in rooms which have a temperature between 68-76 degrees Fahrenheit and that have no draft, radiant heat, (filament) light interference, or reflective backgrounds.[7] Because the technology senses relative infrared radiation, most systems also require a controlled temperature reference (called a blackbody) to compare the radiation density between the individual and the ambient environment. A relatable analogy to the purpose of the blackbody is comparing a white tissue (blackbody) to the color (heat radiation) of one’s teeth to determine if one’s teeth are truly white (heat saturated). The relative differences between the thermal maps of the blackbody and the scanned individual can be used to estimate skin temperature with relatively high confidence (this study found skin temperature variations of ±10 degrees Fahrenheit and within a 95% confidence interval),[8] meaning that measured temperatures were generally accurate within 2-3 degrees Fahrenheit.[9]
Additionally, FLIR, one of the most prominent thermographic device manufacturers concedes that the technology has technical limitations and is not suitable as the sole diagnostic tool for identifying individuals with COVID.[10]
Regardless, the aforementioned CDC study found that although thermal imagery systems are highly dependent on controlled environments, infrared tech can reliably detect “elevated skin temperatures” and are significantly more accurate at determining fever than self-reported questionnaires (In this study, only one tenth of those who reported a fever were actually febrile).[11] Overall, the technology, once calibrated and controlled, can determine core temperatures with similar accuracy to more traditional oral temperature measurements.[12]
Legal Implications of NCITs
NCITs are governed exclusively by the FDA under part 201(h) of the FD&C Act 21 U.S.C. § 321(h), which governs some medical devices.[13] Generally, these medical devices are those which are intended for use in the diagnosis of disease or other conditions, or in the “cure, mitigation, treatment, or prevention of disease.”[14] However, thermal devices that are not intended for such a purpose are not within the regulatory scope of the FDA, meaning the Food, Drug, and Cosmetic Act (FD&C) does not apply to those businesses or individuals using nonmedical thermal devices. Of course, the definition of a medical device under 201(h) is dependent on the intent of the user, so thermal imaging systems that were originally unintended for COVID screening should still comply with the FD&C and other relevant FDA guidance.[15] However, the FDA promotes the use of thermal imaging technologies as a preliminary tool for COVID screening. The FDA states that businesses (because the COVID-19 pandemic is defined as a public health emergency) likely need not comply with many medical device regulations so long as such use does not “create undue risk.”[16]
Privacy Concerns
HIPAA
HIPAA, the flagship federal legislation that protects medical health information is rendered obsolete in the age of contact tracing. HIPAA applies primarily to health plans, clearinghouses and health care providers, of which Google, Apple, PwC, PopId and Clear (contact tracing powerhouses) are not.[17]
Searches
It is also important to note that thermal imagery can qualify as a “search,” but Constitutional protections for unreasonable searches and seizures only apply to government actors. However, there is evidence that tech companies have shared location data with government agencies to help track the spread of COVID.[18] This data may be aggregated and anonymized, but combining relevant data sets may reidentify that data, revealing private medical data traceable to specific individuals. Apparently, 63% of individuals can be uniquely identified by a combination of gender, date of birth, and zip code alone.[19] By combining different data sets which have both “anonymized” or “aggregate” direct or indirect personal identifiers, many anonymous data sets can be reidentified, compromising the privacy of specific individuals.[20]
ADA
The Americans with Disabilities Act (ADA) enforces nondiscrimination based on disability (under which COVID may qualify) and binds all private employers with fifteen or more employees.[21] However, the U.S Equal Employment Opportunity Commission (EEOC) explicitly states that the ADA should not interfere with COVID-19 guidelines made by the CDC.[22] Temperature and other COVID tests must be ‘job related and consistent with business necessity’ and employees may be furloughed or excluded if they have a “medical condition” that would pose a direct threat to health or safety (such as COVID-19).[23]
State Privacy Laws
Of course, there are some existing protections such as the California Consumer Privacy Act (CCPA), Vermont’s data broker registration law, and Illinois’s biometrics law (BIPA), each of which either contain a public health emergency, “direct relationship” or other exception, meaning that most contact tracing companies are exempted from complying with these privacy laws until they are amended or COVID is no longer classified as a health emergency.[24]
Two companies, Clear and PopID have already begun using biometric face scanning and thermal imaging technologies to monitor COVID-19 in businesses and other public places.[25] Some restaurants are implementing these screening procedures in response to the White House guidelines, which require businesses to “monitor workforce[s] for indicative symptoms.”[26]
Pending Federal Legislation
Amid concerns of private health information gathered from COVID screening, senators have introduced a COVID-19 privacy bill which would: (1) require express consent to collect, process or transfer “personal health, geolocation, or proximity information”; (2) disclose to whom that data will be transferred to and retained by; (3) give individuals the opportunity to opt out of their health information being stored or compiled; and (4) give individuals the right to delete or deidentify all personal information that is no longer being used.[27] However the bill has been criticized for preempting stricter state laws (including the CCPA) and not providing a private right of action.[28]Another bill, the Public Health Emergency Privacy Act (PHEPA), is sufficiently broad in its definitions of medical health data, contains clauses for nondiscrimination against those who opt out of COVID tracing programs, and does not undermine existing state data privacy laws through preemption.[29]
The novel coronavirus is just that, novel. Government health agencies and businesses are scrambling to adapt to the constantly changing circumstances. Due to resurgences in cases, the global pandemic has appropriately been categorized as a national health crisis. There is evidence that contact tracing, health screening, and mass temperature scanning can help mitigate the spread of the virus, or at the very least, allow researchers to learn more about the virus. The remaining question is what we are willing to give up in the process. Will government agencies forfeit the private health data that was shared with them once the virus subsides? If so, how will the government and cooperating tech companies protect individuals’ data privacy?
[1]Pejman Ghassemi et al., Best Practices For Standardized Performance Testing of Infrared Thermographs Intended For Fever Screening, PLoS ONE, 1710 (Sept. 19, 2018), https://doi.org/10.1371/journal.pone.0203302 [https://perma.cc/SUB3-8JKB].
[2]U.S. Food and Drug Administration, Enforcement Policy For Telethermographic Systems during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Food And Drug Administration, 2 (April 2020), https://www.fda.gov/media/137079/download [https://perma.cc/SZ4J-RGXU].
[3]An Nguyen, et al., Comparison of 3 Infrared Thermal Detection Systems and Self-Report for Mass Fever Screening, Centers For Disease Control and Prevention, 1713-14 (Nov. 2010), https://www.cdc.gov/eid/article/16/11/10-0703 [https://perma.cc/5CXG-TAZS].
[4] U.S. Food And Drug Administration, Thermal Imaging Systems (Infrared Thermographic Systems/ Thermal Imaging Cameras), Food and Drug Administration (May 13, 2020), https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/thermal-imaging-systems-infrared-thermographic-systems-thermal-imaging-cameras [https://perma.cc/89CQ-WR8N].
[5]U.S. Food and Drug Administration, supra note 2, at 3.
[6] Jay Stanley, Temperature Screening and Civil Liberties During an Epidemic, American Civil Liberties Union, 1-4 (May 19, 2020), https://www.aclu.org/aclu-white-paper-temperature-screening-and-civil-liberties-during-epidemic [https://perma.cc/8ZVH-AUHP].
[7]U.S. Food and Drug Administration, supra note 4.
[8] Nguyen, supra note 3, at 1713.
[9] Id.
[10]Frequently Asked Questions: Thermal Imaging for Elevated Skin Temperature Screening, FLIR (May 13, 2020), https://www.flir.com/discover/public-safety/faq-about-thermal-imaging-for-elevated-body-temperature-screening/ [https://perma.cc/J2AG-X9MM].
[11] Nguyen, supra note 3, at 1713-15.
[12] Id. at 1713.
[13] U.S. Food and Drug Administration, supra note 2, at 3.
[14] Id.
[15] Id. at 4.
[16] Id.; pt. 510(k) of the FD&C Act (21 U.S.C. § 360(k)) (requiring device certification and quality testing before the introduction of the device into interstate commerce); 21 C.F.R. pt. 807.81 (requiring device manufacturers to submit a premarket approval request to the FDA before commercial distribution of the device); 21 C.F.R. pt. 806 (governing the scope and definitions of manufacturer liability for medical devices that have been removed or corrected from current marketed equivalents); 21 C.F.R. pt. 80 (governing medical device registration); 21 C.F.R. pt. 820 (governing device quality control and system requirements); 21 C.F.R. pt. 830 (requiring unique identifiers for medical devices); 21 CFR pt. 801.20 (governing labeling requirements for medical devices).
[17]U.S. Department of Health and Human Services, HIPAA for Professionals (April 2015), https://www.hhs.gov/hipaa/for-professionals/privacy/index.html [https://perma.cc/RE33-8JTK]; Adam Schwartz, Two Federal COVID-19 Privacy Bills: A Good start and a Misstep, Electronic Frontier Foundation (May 28, 2020), https://www.eff.org/deeplinks/2020/05/two-federal-covid-19-privacy-bills-good-start-and-misstep [https://perma.cc/TFW6-LWBR].
[18] Garret Stone, Constitution in Crisis: The Fourth Amendment and Combating COVID-19, Wake Forest J. of L. and Pol’y (April 20, 2020), https://wfulawpolicyjournal.com/2020/04/20/constitution-in-crisis-the-fourth-amendment-and-combating-covid-19/ [https://perma.cc/98TB-F4TM].
[19]Boris Lubarsky, Re-identification of “Anonymized” Data, 1 Geo. L. Tech Rev. 202 (2017), https://georgetownlawtechreview.org/wp-content/uploads/2017/04/Lubarsky-1-GEO.-L.-TECH.-REV.-202.pdf [https://perma.cc/AU9G-E4FA].
[20] Id.
[21]U.S. Equal Employment Opportunity Commission, What You should Know About COVID 19 and ADA Rehabilitation Act, and Other EEO Laws (June 17, 2020), https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws [https://perma.cc/F2TN-LAY5].
[22]Id.
[23]Id.
[24] Adam Schwartz, Vermont’s New data Privacy Law, Electronic Fronteir Foundation (Sept. 27, 2018), https://www.eff.org/deeplinks/2018/09/vermonts-new-data-privacy-law [https://perma.cc/MH8P-QE4B]; Daniel Gottlieb, California Bill Proposes CCPA Exceptions for HIPAA De-Identified Information, McDermott, Will and Emory, (Jan. 17, 2020), https://www.mwe.com/de/insights/california-bill-proposes-ccpa-exceptions-for-hipaa-de-identified-information-other-health-data/ [https://perma.cc/BR9P-GJ2Z]; Illinois General Assembly, § 740 ILCS, https://www.ilga.gov/legislation/ilcs/ilcs3.asp?ActID=3004&ChapterID=57s/california-bill-proposes-ccpa-exceptions-for-hipaa-de-identified-information-other-health-data/ [https://perma.cc/8TBQ-CDUP].
[25]Natasha Singer, Employers Rush to Adopt Virus Screening. The Tools May Not Help Much., New York Times, (May, 11, 2020), https://www.nytimes.com/2020/05/11/technology/coronavirus-worker-testing-privacy.html [https://perma.cc/7AMC-QANC].
[26]Centers for Disease Control, Opening Up America Again, https://www.whitehouse.gov/openingamerica/ [https://perma.cc/MKT6-Z9MG].
[27]John Thune, Thune Wicker, Moran, Blackburn Announce Plans to Introduce Data Privacy Bill, US Senator for South Dakota (April 30, 2020) https://www.thune.senate.gov/public/index.cfm/press-releases?ID=37E557F5-566E-4872-A66D-EBBFEC1D190A [https://perma.cc/F6RM-LCZN].
[28]U.S. Department of Health and Human Services, supra note 17.
[29]Id.