Technology Assessment (TA) is an investigation and evaluation method born in the mid sixties from the need to express a critical judgment about the role of technology in modern society and its potential, even if not intentional and sometimes harmful, consequences.
Its first applications have been related to issues like offshore oil drilling, pesticides, traffic pollution, nuclear power plants, supersonic airplanes and the artificial heart. TA has been conceived as a method to identify and foresee the main effects of these technologies, but also the secondary, social, economical and environmental ones.#
The term “Technology Assessment” has been introduced for the first time in 1965 during the works of the Committee on Science and Astronautics of U.S. House of Representatives.
Emilio Daddario, member of the Committee, underlined in his speech that the purpose of TA was to serve politics:
The technical information that politicians need is not easy to find and, if available, it is difficult to understand. A politician could not be able to judge about the benefit and the consequences of a technological program if it is only explained on a technical level. He should be able to consider all the social, economic and legal aspects of each action line.#
Many observers were afraid that politicians could have used the TA as a way to limit the development and the use of technology. This was not the purpose of the Committee or the agencies in charge of the first evaluations, though. In 1969, a report of NAE Congress# pinpointed that:
TA should help the Congress to be more efficient in assuring that either public and private interest are taken into consideration whenever there is a technology able to contribute to the well-being of our society.#
Private industry began to use TA methodology with a different purpose, in order to increase its possibilities to compete in the market, enhance the comprehension of the future economic context and elaborate a concrete forecast to support internal and external judgments and choices about the system.
TA methodologies involve and use a series of analysis, evaluation and planning. Among them: systems’ analysis, cost-benefit analysis, decision-making strategy (e.g., Delphi method), feasibility studies, clinical studies, marketing researches, technology forecasting and many others. All of them are involved in a flexible evolutionary process recognized by the most important sector professionals and politicians.#
Before the rise of Health Technology Assessment (HTA), the study of technologies in the health industry wanted to provide short-term safety elements, effective tools, costs assessment and evaluation of social impact (Box 38). The growth of HTA allows focusing the interest on a wider overview of the problem.
The first model evaluated with HTA methodology was the analysis of Multiphasic health screening, on behalf of the National Academy of Engineering in 1969, related to the determination of sex diseases in the fetus in artificial insemination process.
The development of HTA was catalyzed by the emergence and spread of technologies that have arisen social, ethical, legal and political issues. They include the introduction of contraception, organ transplantation, artificial organs and instruments suitable to sustain life artificially in the terminally ill and, more recently, genetic testing, gene therapy and stem cell research. These technologies have undermined the social institutions, ethic values, and other rules concerning the fundamental aspects of human life such as parenting, heredity, birth, the right to decide about someone’s own body, freedom and human rights.#
Obviously this does not mean that the usefulness of HTA is only linked to these purposes, but its remarkable development is due to the value interest that such issues arise. It allows creating solid strategies and methodologies which can be very useful in the medical and biomedical context.
According to Clifford S. Goodman#, there are three ways to describe HTA: understanding its material nature, its purpose, and its dissemination phase.
- Material Nature
For many people, the term “technology” is a synonym for “hardware” or other mechanical devices; for others, it is a shortened form for “information technology”. However, the knowledge in the health sector has a wide range of applications:
- Drugs: e.g., administration or production of medicines such as aspirin, beta-blockers, antibiotics, etc.
- Biology: vaccines, blood products, cellular and gene therapies.
- Devices, equipment and supplies: e.g., cardiac pacemakers, CT scanners, surgical gloves, diagnostic kits.
- Medical and surgical interventions: e.g., psychotherapy, nutritional counseling, angiography, the removal of the gall bladder, etc.
- Support systems: e.g., electronic patient records, telemedicine systems, medicine forms, blood banks, clinical laboratories.
- Management systems: e.g., payment using DRG systems (Diagnosis Related Groups), clinical pathways, quality of services and more.
The object of this study will focus on these last two points.
- Purpose or application
The technologies can be grouped according to their purpose:
- Prevention: in order to avoid spreading disease, reducing the risk or limiting its extent and consequences (e.g., immunization, hospital infection control).
- Screening: in order to identify an illness, disability, or risk factors in asymptomatic patients
- Diagnosis: in order to identify the cause, nature or extent of the disease in a person with clinical signs or symptoms (e.g., electrocardiogram, typhoid test, X-rays for possible broken bones).
- Treatment: designed to improve or maintain health status, to avoid further worsening or to provide palliative care systems (e.g., antiviral therapy, aortocoronary bypass, psychotherapy or medications for cancer pain).
- Rehabilitation: in order to restore, maintain or improve a physical function or mental disability or health status (e.g., the exercise program for post-stroke patients).
Some technologies can be “boundary-crossing” or “hybrids” because they span multiple purposes.
- For instance, information technology support systems whose purpose is to optimize the systems supporting the efficiency of the system they are applied to. And they manage to do it:
- Speeding the processes up: e.g., delegating to a machine part of the bureaucratic functions, such as the compilation of folders, etc.
- Providing and processing data: e.g., to have a simple and precise analysis of the data access to a hospital in statistical form allows evaluating what are the shortcomings of the system to better meet the demands.
- Dissemination phase
Technologies can be evaluated in different phases of dissemination and maturity. In general, health care technologies can be described as:
- Future: expectations in the conceptual stage or during the first stages of development.
- Experimental: laboratory tests on animals or other models.
- Investigative: in initial clinical evaluation phase for a particular condition or indication.
- Established: considered by providers as a standard approach in a particular condition.
- Obsolete / abandoned: overtaken by other technologies or proven to be ineffective or harmful.
The classification is not strict, in fact, some technologies are in the middle between two phases.
The main purpose of HTA is to provide information in order to evaluate and understand the decisions taken at all levels and different points of view, from the economic one until the user’s satisfaction. HTA is conducted by interdisciplinary teams, which draw on various methods. As a matter of fact, there are three basic tendencies, not necessarily related to the technological aspect:
- Technology-oriented assessments are intended to determine the characteristics and impacts of particular technologies. For instance, HTA can be useful to a government agency to determine the economic, social, professional, industrial impacts of a particular technology on a population.
- Problem-oriented assessments are solutions or strategies for managing a particular problem for which there may be complementary or concurrent alternative technologies. For example, in the study of dementia, doctors can require the evaluation and development of methods of investigation that give a different weight to different medical data (neurological examinations, diagnostic examinations, etc.) in order to assess which one is the best.
- Focusing or project-oriented assessment are evaluations about the “local” and specific use of a technology in a particular environment or project. For example, this kind of evaluation can occur when a hospital must decide whether or not to purchase a machine for magnetic resonance imaging (MRI), considering the facilities, the personnel and the other resources needed to install and operate an MRI machine, the financial position of the hospital, the potential of the local market for MRI services, competitive factors, etc.
Obviously these tendencies are not mutually exclusive and can coexist within HTA.
Despite the above examples related to a prior assessment of feasibility, there is not an ideal moment to make correct HTA: there is just a general rule about the most appropriate moment to make it. The sooner you make it, the sooner you will found out if its dissemination can be secure and effective.#
However, considering the results of a premature assessment as definitive and final may be misleading.
In fact, a technology being tested can still be improved, the users may still not be able to appreciate its full potential, its costs may not yet have stabilized and could not have been enough and properly applied to recognize its actual benefits.#
It is good to know that the decision about the right moment to make HTA is very important and that “It’s always too early until it’s suddenly too late!”#
The moving target problem, as they call it in the U.S., is also to be considered.# It is referred to the fact that HTA often take a long time, during which technology evolves and can make the decisions taken totally ineffective. This can happen above all in the informatics field, where technological discoveries can change the whole system in few months. However, the main purpose for management software is to aim at stability and efficiency through solid and established systems.
The main purposes of HTA are:
- Technical features: performance and compliance with the specifications for the design, composition (in case of chemicals), manufacturing, tolerances, reliability, ease of use, maintenance, security, etc.
- Safety: it is an evaluation of the risk acceptance (a measure of the probability of a failure and its severity).
- Efficiency and effectiveness: these features refer to how a technology works in order to improve the health of the patient. In HTA, effectiveness refers to the advantage of using a technology for a particular problem under ideal conditions, e.g., a protocol controlled and carefully managed. Efficiency refers to the advantage of using a technology for a particular problem in general or routine conditions, e.g., a doctor at a community hospital for a variety of types of patients#.
- Economical aspect or impact: HTA can have a wide range of both microeconomic and macroeconomic aspects. More precisely, the microeconomics aspects include costs, prices, rates and payment levels associated with people.# Other critical issues are the cost-effectiveness ratio, costs utility, and cost-benefit ratio.
- Social, legal, ethical and political impact: a variety of technologies lead to a natural tendency to arise social or ethical concerns. Technologies such as genetic testing, the use of stem cells, the allocation of organs for transplants and life support systems for the terminally ill generate critical issues that often collide with the shared social and legal norms. Ethical issues also require the improvement of policies and procedures for informed consent for patients involved in clinical trials. The ethical problems related to the allocation of resources to technologies that are expensive, unsuccessfully used and abused arise wide social concerns.#
In general, though not a strict guideline, according to Clifford S. Goodman, the basic steps to develop an analysis of HTA# consist in:
1. Identifying clearly the purposes of the assessment
2. Outlining the evaluation-related issues
3. Determining the assessment site
4. “Retrieving evidence”
5. Collecting and organizing properly the most important data
6. Assessing / Interpreting data
7. Integrating / Synthesizing data
8. Formulating conclusions and recommendations
9. Spreading conclusions and recommendations
10. Monitoring the impact
Conducting an assessment program, it is not necessary to follow each one of these steps and also the order can be changed. Many HTA programs are based on integrative methods of data review and synthesis from current studies, e.g., specialized magazines’ articles of public bodies which do not collect all primary data, though.
Some evaluative approaches involve various data retrieve / collection / interpretation cycles, so that it is possible to integrate data with other elements before give an evaluation.
For instance, to obtain the approval for marketing a new drug a pharmaceutical company usually sponsors various data collections: the preclinical testing in laboratory and on animals of phase 1 and 2, phase 3 on humans, and above all the study of phase 4 after the marketing of the product.
“Worldwide” Digital Health and technology assessment
It is not easy to find examples and specific documentations about this field. The use of computer tools aimed at optimizing the procedures, easing the workload for the bureaucracy and generally enhancing the organization of systems is uniquely, and often unfairly, regarded as a definitely positive impact on population. These conditions often make unnecessary the application of HTA.
Analysis about this matter have been made in many areas, e.g., remote automatic monitoring of the status of a patient with cardiac problems, but no analysis have been conducted about the application of technology for streamlining the organization of ways of access to hospitals.#
Elements of similarity
As it was previously said, HTA is born with a political purpose linked to the need, that the American government has always requested, to prove the efficiency in the use of public property. The federal nature of the American country, often poorly accepted, implies that particular attention to the use of public resources is paid. For this reason, it is necessary a system that can predict the impact, not only economic, of a technology on the population.
Usually this need arises where investments in new technologies are significant and must be justified by a solid analysis and forecast of operation, both in private and public affairs. The privatization and the streamlining of some public functions (as from USL to ASL in Italy#) lead to the fact that a study that would justify the choices of expenditure is increasingly necessary in all fields, especially in the medical one, which, more than any other, has a strong impact on the social life of individuals.
In a system that does not require public explanation (or justification towards the investors) about what has been done, there is no need to make TA.
Elements of difference
What differentiates the various types of HTA, especially in the field of Digital Health, is not the purpose of analysis, but the way in which the investigation methodologies must be adapted to the existing laws, values and parameters that are deemed of interest to the population of the geographic area they are applied to.
For instance, HTA has a structure that is suitable for Unites States Committee, but in Europe it has a different structure.
- Making an assessment application / outlining an assessment need.
- Evaluating the priorities.
- Choosing the analysis company to which delegate the project.
- Making the assessment:
- Definition of political issue
- Elaboration of HTA protocol
- Collecting background information about technology status
- Definition of the research problems
- Research of data source, test evaluation methods, and its synthesis about:
- effectiveness / efficiency
- psychological, social, ethical
- organizational, professional
- Formulating the discussion, conclusion, recommendations of the analysis
- External review
- Publishing of HTA definitive report
- Dissemination of analysis
- HTA use
- HTA update according to technologies development and progress system status
The point 4h is very interesting because it is referred to the need to have data analyzed by external companies in order to be sure about the neutrality of the analysis towards the political side.