Abstract
The advances in biotechnology and computer and data sciences opened the way for innovative approaches to human healthcare. Meanwhile, they created many ethical and regulatory dilemmas such as pervasive global inequalities and security and risk to data privacy. The assessment of health technology is a systematic multidisciplinary process that aims to examine the benefits and risks associated with its use including medical, social, economic, and ethical impacts. It is used to inform policy and optimize decision-making. The advance of technology is creating significant challenges to healthcare regulators who strive to balance patient safety to fostering innovation. The FDA and EMA are modernizing their regulatory approaches to foster innovation in digital technology and improve safety and applicability to patients. On the other hand, data analytic technologies have been introduced into regulatory decision processes.
TopBackground
The “Health Technology” term was defined in the 6Th World Health Assembly (2021) as: “the application of organized knowledge and skills within the sort of devices, medicines, vaccines, procedures, and systems developed to unravel ill health and improve quality of lives”. (WHO, 2021)
The assessment of health technologies is a multidisciplinary process that systematically examines evidence about their various impacts including medical, social, economic, and ethical aspects. A comprehensive assessment requires knowledge and experience beyond the scope of ethical analysis including awareness of the spectrum and principles of the technology and the related impacts on all stakeholders. Transparency, freedom from bias, and robustness are essential qualities to ensure the validity of the assessment (www.eunethta.eu)
In the next sections, the spectrum of health technology, its ethical and regulatory challenges, assessment frameworks, and regulations will be discussed.
1. The Definition and Spectrum of Health Technology
The term 'health technology' encompasses a wide range of interventions, used for disease prevention, diagnosis, and treatment as well as rehabilitation and long-term care. In other words, it includes interventions intended to promote individual and population health.
It also applies to other broad applications such as restructuring of the health service through standardization or reallocation of resources.
Health technology can be categorized according to its type and intended use into:
- 1.
Physical agents such as drugs and biologics e.g., vaccines and gene and cell products, devices and supplies e.g., cardiac pacemaker, implants, and magnetic resonance imaging (MRI) scanner, and procedures both medical and surgical
- 2.
Public health programs e.g., newborn screening and immunization
- 3.
Support Service e.g., clinical laboratory, blood bank, electronic health record system, telemedicine, and drug formulary
- 4.
Organizational and managerial systems e.g., medication adherence program and alternative health care
Some applications combine more than one category e.g., drugs and devices (Lauritsen 2009) such as the positron emission tomography (PET) used with radiopharmaceuticals.
Innovative technologies can also be divided into evolutionary, the most common, and revolutionary, which is sporadically applied and include innovative applications in different subfields. (Iserson and Chiasson, 2002)
Key Terms in this Chapter
Decision Algorithms: Is a hierarchical flow of answers to an upper-level question based on the input data for a given decision problem.
Beneficence: Is the act of benefitting others which is an obligation of the physician towards his patient and is one of the bioethics principles.
Machine Learning: Is a computer algorithm program which automatically learns and adapts to new data without human interference.
Governance: Is the act of supervised control of a given working party by an authorized body.
Tele-Health: Is the delivery of healthcare service or communication on a distance via technology.
Gene Editing: Is the change of a gene constitution by inserting external DNA pieces with the use of technology. It has a therapeutic benefit in some genetic disorders.
Techno-Ethics: Is the subfield of ethics which analyzes the addresses the ethical dimensions in the production and application of technology.