Biomedical Engineering Reference
In-Depth Information
specific application that will be used and the domain within which it has
to be embedded. The blurring boundaries between the purposes of dif-
ferent applications are problematic for quality control and reimbursement
issues and therefore needs further consideration. In this regard, Hatcher and
Heetebry (2004) argue that while the convergence of the various technologies
and fields is causing a revolt of innovative technologies into the health-care
practice, it is at the same time causing a paradigm shift that is blurring the
boundaries between public health, acute care, and preventative health. This
has implications for the way social and ethical impact of the applications are
assessed. Furthermore, it has been argued by health-care professionals in our
interviews that the symptoms associated with different illnesses often con-
verge; therefore, health-care processes cannot be taken over by technologies
measuring factual data alone because this might undermine the whole care
aspect of the medical profession, causing a negative impact on the patient.
The blurring boundary between health-care and wellness-related applica-
tions of the BAN concept also raises questions to the way these technologies
are assessed. Namely, the desire for a more efficient, organized health-care
process is a societal issue and is based on the normative argument that while
the society as whole invests in health care, it is expected that the society
will become healthier as a result. However, at a time when the responsibil-
ity for the health state of individuals is pushed more and more toward the
individuals themselves, and technologies are being developed to support
persons taking such responsibility, the question has to be raised whether
the issue is about becoming healthier or are technologies being developed
to also contribute to the wellness and lifestyles of patients? This has a conse-
quence for the assessment norms that are applied to technologies, for exam-
ple, to approve reimbursement policies. In other words, the normative frame
in which technologies are being assessed should be adjusted to their general
purpose and the context of use of technologies that are being developed.
12.3.3.2 Different Applications and Quality Control of Services
One entrance point to finding requirements is the market introduction (in
a broad sense) of services enabled by the BAN concept. While there are
existing regulations such as various medical device directives (e.g., Medical
Device Directive 93/42/EEG), new applications of BAN in some cases can be
seen as medical services (e.g., monitoring of patients with increased risk of
heart failure) rather than just devices, and the quality and the management
of the service in itself is important to consider. This is challenging because
many of these so-called e-Health services are yet under development and
might adopt many different forms and sizes. Other applications, for instance,
related to lifestyle management and preventive care, can also be provided by
private parties, such as sport consulting firms, which can provide preven-
tive advises on the basis of monitoring the performances of their clients. The
motivation to, and success of, market introduction is linked to capturing a
