Ethics for Digital Medicine A Path for Ethical Emerging Medical IoT Design Sudeep Pasricha

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Ethics for Digital Medicine: A Path for

Ethical Emerging Medical IoT Design

Sudeep Pasricha

Colorado State University

Abstract—The dawn of the digital medicine era, ushered in by increasingly powerful embedded

systems and Internet of Things (IoT) computing devices, is creating new therapies and

biomedical solutions that promise to positively transform our quality of life. However, the digital

medicine revolution also creates unforeseen and complex ethical, regulatory, and societal

issues. In this article, we reflect on the ethical challenges facing digital medicine. We discuss

the perils of ethical oversights in medical devices, and the role of professional codes and

regulatory oversight towards the ethical design, deployment, and operation of digital medicine

devices that safely and effectively meet the needs of patients. We advocate for an ensemble

approach of intensive education, programmable ethical behaviors, and ethical analysis

frameworks, to prevent mishaps and sustain ethical innovation, design, and lifecycle

management of emerging digital medicine devices.

 Digital Medicine refers to smart healthcare

products that have a direct impact on diagnosing,

preventing, monitoring, and treating a disease,

condition or syndrome. These products make use of a

wide range of embedded systems and Internet of

Things (IoT) devices, e.g., as part of nanobots for

precise delivery of drugs to specific organs with

pinpoint accuracy, intelligent locomotive and sensory

prosthetics, and augmented/virtual reality limb

rehabilitation solutions for patients that have suffered

from stroke, cerebral palsy, and traumatic brain injury.

Many of the requirements of traditional medications are

shared by digital medicine devices (DMDs), such as the

need for approval from regulatory bodies before

accessing the market. But there are also differences.

Unlike standard medicines that primarily rely on new

active principles, DMDs rely heavily on the design of

innovative embedded and IoT computing platforms

with custom form factors (e.g., nanoscale), unique

computational and networking capabilities, and

stringent power and energy budgets, that can be

combined with traditional therapy or medication.

As digital medicine often plays a key role in matters

of life and death, it is important to consider ethical

implications in all aspects of the design, deployment,

and usage lifecycle of its technological components. It

is important here to make a distinction between ethics

and laws. In our modern society, laws establish

minimal requirements of behavior for individuals and

social institutions to function well. They enable us to

have orderly interactions with one another within a

framework of basic fairness. But they are narrow in

scope and say nothing, for example, about how life-

critical decisions should be made in autonomous

vehicles or how to tackle misinformation and deep

fakes. Ethics goes beyond law to identify moral issues,

reflecting on the nature of society we want to live in

based on ideas of what a good life looks like. It makes

recommendations that allow us to strive towards ways

of life that will be most conducive to our own and

others’ wellbeing.

Ethical concerns are no stranger to medicine. After

all, thousands of years ago, Hippocrates, considered the

father of Western medicine, was urging physicians to

do no harm. The discipline of medical ethics, however,

did not fully develop until the 1970s. Two factors

contributed to the development of medical ethics [1].

First, medical scandals emphasized the need for ethical

standards and regulation. For instance, the Tuskegee

Syphilis Experiment scandal in 1972 revealed that

subjects with syphilis had gone untreated for four

decades despite treatment being available, and without

the knowledge or consent of subjects. Second,

advances in technology confronted doctors with new

ethical challenges they did not know how to resolve.

The mechanical ventilator, for instance, forced a

rethink of the concept of death and organ transplants.

Doctors now had access to bodies without functioning

brains but with working organs that could be

transplanted. It became clear that addressing such

ethical dilemmas required experts other than healthcare

professionals whose primary expertise was in keeping

people healthy, and not in resolving ethical problems.

Today, the biomedical field has come to prioritize

four foundational ethical principles – justice (fair,

equitable, and appropriate treatment of patients),

respect for autonomy (relating to a patient’s capacity to

self-determine), beneficence (obligation to act for the

benefit of the patient), and non-maleficence (avoiding

harm to the patient). These principles help realize a

common morality that must also be applied to emerging

DMDs, during their design and development (including

during clinical trials), as well as during post-

deployment monitoring and troubleshooting (including

product recalls and replacements). Fortunately,

medical device development is already regulated, with

codes, guidelines, and standards aimed at protecting

patients [2]. However, the ethical framework within

which these directives work remains unwritten and

nebulous. Coupled with rapid advances in digital

medicine technology and evolving societal values,

engineers working on digital medicine products are

increasingly facing gray areas not covered by codes and

regulations.

Part of the challenge is that the fields of ethics and

technology development have very distinct cultures [3].

For instance, while ethics often draws out discussion by

way of analogies and thought experiments, the

technology development field tends to make use of

more direct, concrete cases. Where ethics is keen to

critique theories and methods, technology engineers are

more interested with usable results. And where the

practice of ethics can take substantial time to conduct

analyses, technological developments must minimize

time and other expenditures. As engineers and

scientists working on medical technologies are unlikely

to become experts in ethical reasoning, there is a need

to identify robust methodologies that can integrate

ethical considerations across the DMD lifecycle.

The other challenge has to do with the complexity

of multiple stakeholders in the DMD lifecycle. One

may think that patients are the primary stakeholders

with DMDs, but not always. For instance, a DMD

designer should consider manufacturing engineers as

stakeholders because design decisions can lead to the

use of chemicals during manufacturing that may be

hazardous to those engineers (and violate the principle

of non-maleficence from their perspective). Of course

this stakeholder has little relevance once a device is in

the market. Or consider the choice of material early in

the design phase of an implantable left ventricular

assist device (LVAD). It may be beneficial to consider

a liability lawyer as a stakeholder in the device post

deployment phase, as instances of the material ending

up being the source of adjacent tissue damage and

infections could shift the balance away from true

beneficence to society from the perspective of the

liability lawyer, even though that material may have

been one of the easiest to use in manufacture. Thus,

identifying the appropriate stakeholders, of which there

can be many, is crucial for effective ethical analysis

during a DMD lifecycle.

This article reflects on the ethical challenges facing

digital medicine. While some prior surveys have

discussed ethics for health-related IoT devices, e.g.,

[13], their scope primarily pertains to technological

challenges, e.g., creating secure and privacy-preserving

hardware/software solutions. In contrast, our scope is

more up to date and also broader, covering ethical

challenges with digital medicine from a technological

as well as a regulatory, professional, societal, and

educational perspective.

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EthicsforDigitalMedicine:APathforEthicalEmergingMedicalIoTDesignSudeepPasrichaColoradoStateUniversityAbstract—Thedawnofthedigitalmedicineera,usheredinbyincreasinglypowerfulembeddedsystemsandInternetofThings(IoT)computingdevices,iscreatingnewtherapiesandbiomedicalsolutionsthatpromisetopositivelytrans...

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Ethics for Digital Medicine A Path for Ethical Emerging Medical IoT Design Sudeep Pasricha

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