Ingestible electronic sensors are a promising technology for improving health outcomes that may, for example, be useful in monitoring and promoting the taking of medication. However, these sensors also raise ethical and legal challenges that need to be considered by all stakeholders—notably, the creators of such products—at the earliest stages of the development process. Here, we examine selected ethical and legal issues related to ingestible electronic sensors. We first briefly describe sensors that are already available on the US and European markets as well as potential future sensor combinations. We then focus on ethical aspects, discussing patient, provider, and social issues. Finally, we provide a comparative analysis of legal regulation of ingestible electronic sensors in the US and Europe.
Subscribe to Journal
Get full journal access for 1 year
only $8.67 per issue
All prices are NET prices.
VAT will be added later in the checkout.
Rent or Buy article
Get time limited or full article access on ReadCube.
All prices are NET prices.
Digital Health (FDA, 2018); https://www.fda.gov/medicaldevices/digitalhealth
EHealth: Digital Health and Care (European Commission, 2018); https://ec.europa.eu/health/ehealth/overview_en
Evaluation of Automatic Class III Designation (De Novo) for Proteus Personal Monitor Including Ingestion Event Marker (FDA, 2012); https://go.nature.com/2Yt47L6
Qualification Opinion On Ingestible Sensor System For Medication Adherence As Biomarker For Measuring Patient Adherence As Biomarker For Measuring Patient Adherence To Medication In Clinical Trials EMA/CHMP/SAWP/513571/2015 (European Medicines Agency, 2016).
Proteus Personal Monitor Including Ingestion Event Marker Classification Order (FDA, 2012); https://go.nature.com/2YiMMQU
Council Directive 93/42/EEC, preamble and art. 17; and Directive 98/79/EC, art. 16; and Council Directive 90/385/EEC, art. 12.
Otsuka and Proteus announce the first U.S. FDA approval of a digital medicine system: Abilify MyCite (aripiprazole tablets with sensor). Proteus Digital Health (14 November 2017); https://go.nature.com/2K1bro3
NDA Approval 207202 (FDA, 2017); https://go.nature.com/2YhpQ4E
Highlights of Prescribing Information: Abilify MyCite (aripiprazole tablets with sensor) (FDA, 2017); https://go.nature.com/2GsHVXE
Proteus Digital Health launches digital oncology medicines to improve patient outcomes. Proteus Digital Health (17 January 2019); https://go.nature.com/2XZnHzg
Kalantar-Zadeh, K. et al. A human pilot trial of ingestible electronic capsules capable of sensing different gases in the gut. Nat. Electron. 1, 79–87 (2018).
Mimee, M. et al. An ingestible bacterial-electronic system to monitor gastrointestinal health. Science 360, 915–918 (2018).
Subbaraman, R. et al. Digital adherence technologies for the management of tuberculosis therapy: mapping the landscape and research priorities. BMJ Glob. Health 3, e001018 (2018).
Muoio, D. Pharmacokinetic study of Proteus’ ingestible sensor paves way for clinical trials of HIV prevention drug. MobiHealthNews (26 July 2018); https://go.nature.com/2YnOS6s
Klugman, C. M., Dunn, L. B., Schwartz, J. & Cohen, I. G. The ethics of smart pills and self-acting devices: autonomy, truth-telling, and trust at the dawn of digital medicine. Am. J. Bioeth. 18, 38–47 (2018).
Cohen, I. G. & Pearlman, A. Smart pills can transmit data to your doctors, but what about privacy? New Scientist (19 September 2018); https://go.nature.com/2ZbQayu
Powell, T. P. The ‘smart pill’ for schizophrenia and bipolar disorder raises tricky ethical questions. STAT (5 December 2017); https://go.nature.com/32PPUrb
Zhang, S. Why pharma wants to put sensors in this blockbuster drug. Wired (13 November 2017); https://go.nature.com/2K1l4TX
Fadus, M. Ethical implications of digital feedback in psychiatric medications. J. Ethics Mental Health 10, 1–7 (2018).
Is The Product A Medical Device? (FDA, 2018); https://go.nature.com/2JS8PKx
FDA clears new robotically-assisted surgical device for adult patients. FDA (13 October 2017); https://go.nature.com/2JThZqd.
Federal Food, Drug, and Cosmetic Act, s. 201(h).
Federal Food, Drug, and Cosmetic Act, s. 513(a)(1)(A)–(C); and Title 21 of the Code of Federal Regulations, ss. 880.2720, 864.7825, 870.3925.
Federal Food, Drug, and Cosmetic Act, s. 513(f)(1).
Evaluation of Automatic Class III Designation (De Novo) Summaries (FDA, 2018); https://go.nature.com/30XSytb
Federal Food, Drug, and Cosmetic Act, s. 513(f)(2) and (i).
Title 21 of the Code of Federal Regulations, s. 880.6305.
510(k) Clearances K131009, K131524, K133263 and K150494.
Title 21 of the Code of Federal Regulations, part 807.
Title 21 of the Code of Federal Regulations, s. 801.109.
Frequently Asked Questions About Combination Products (FDA, 2018); https://go.nature.com/2LFMSjS
Robbins, R. A ‘digital pill’ for cancer patients is rolled out for the first time, in hopes of improving outcomes. STAT (17 January 2019); https://go.nature.com/2OrNUCu
Molteni, M. Ingestible sensors electronically monitor your guts. Wired (24 May 2018); https://go.nature.com/2K0ZCOS
Digital Health Innovation Action Plan (FDA, 2017); https://go.nature.com/2Ym78Nj
FDA. Prescription drug-use-related software; establishment of a public docket; request for comments. [Docket no. FDA-2018-N-3017]. Fed. Reg. 83, 58574–58582 (2018).
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices  OJ L169/1.
The Treaty on the Functioning of the European Union, art. 288.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC  OJ L117/1.
Medical Device Regulation, art. 123(1).
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices  OJ L189/17.
Medical Device Regulation, arts. 122 and 123(2) and (3).
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU  OJ L117/176.
In Vitro Diagnostic Medical Devices Regulation, art. 113(1).
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices  OJ L331/1.
In Vitro Diagnostic Medical Devices Regulation, arts. 112 and 113(2) and (3).
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use  OJ L311/67.
Medical Device Directive, art. 1(2)(a).
Medical Device Directive, preamble, art. 9 and annex IX.
Guidance on “Medical Apps” (German Federal Institute for Drugs and Medical Devices, 2015); https://go.nature.com/2Ym8Nm9
Jeary, T. A European perspective and guide to key regulatory considerations for combination products. Regulatory Rapporteur 12, 5–9 (2015).
Medicines Directive, art. 6(1).
Regulation 726/2004, arts. 3, 13(1), annex I and Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004  OJ L324/121, art. 2(1)(d).
New ‘digital’ pills pose data protection and cybersecurity challenges for drugs manufacturers and health bodies, says expert. Out-Law News (16 November 2017); https://go.nature.com/2GrVuqc
Graham, C. NHS cyber attack: Everything you need to know about ‘biggest ransomware’ offensive in history. The Telegraph (20 May 2017); https://go.nature.com/2y82x2K
Smart, W. Lessons Learned Review Of The Wannacry Ransomware Cyber Attack (Department of Health and Social Care, 2018); https://go.nature.com/30ZyxSP
Mendoza, M. Á. Challenges and implications of cybersecurity legislation. WeLiveSecurity (13 March 2017); https://go.nature.com/2JWuhN2
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)  OJ L119/1.
General Data Protection Regulation, arts. 2, 4(15).
General Data Protection Regulation, art. 4(1).
General Data Protection Regulation, art. 4(2).
General Data Protection Regulation, art. 4(15).
General Data Protection Regulation, art. 3(1).
Guidelines 3/2018 on the Territorial Scope of the GDPR (Article 3) — Version for Public Consultation (European Data Protection Board, 16 November 2018).
General Data Protection Regulation, art. 3(2).
General Data Protection Regulation, art. 27.
California Consumer Privacy Act of 2018 (SB-1121), Legislative Counsel’s Digest; Cal. Civ. Code s. 1798.140(g).
The research for this contribution was supported by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme in Biomedical Innovation Law (grant agreement no. NNF17SA027784).
I.G.C. has served as a consultant for Otsuka Pharmaceutical on their Abilify MyCite product. The company neither funded the preparation of this Perspective nor played a role in its drafting or review.
Publisher’s note: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
About this article
Cite this article
Gerke, S., Minssen, T., Yu, H. et al. Ethical and legal issues of ingestible electronic sensors. Nat Electron 2, 329–334 (2019). https://doi.org/10.1038/s41928-019-0290-6
BMC Medical Ethics (2020)