IEEE Technology and Society Magazine - December 2015 - 39

FDA [11]. The Court held that state
common law claims of negligence,
strict liability, and breach of implied
warranty against a device's manufacturer were preempted by the
MDA, and that states cannot establish requirements that are different
from, or add to, any federal requirement applicable to the device [13].
The Court indicated that "State tort
law that requires a manufacturer's
[device] to be safer, but hence less
effective, than the model the FDA
has approved disrupts the federal
scheme no less than state regulatory law to the same effect." Plaintiff's
claims were preempted because
they attempted to establish state
requirements for safety that were
"different from, or in addition to"
the federal requirements, although
the Court indicated that the federal
law "does not prevent a State from
providing a damages remedy for
claims premised on a violation of
FDA regulations; the state duties in
such a case parallel, rather than add
to, federal requirements" [12, supra
note 122, pp. 322-323].
A s a p opu lat ion bec ome s
increasingly dependent on electronic medicine for its state of health,
ownership and control of the
pharmaco-electronic prescriptions
will need fresh consideration. For
example, who will decide availability, price, performance/warranty,
safety, personal security, and ownership of data, and who will control
the intellectual property, such as
patent/copyright licensing, which
may affect access for upgrading
device hardware/software or repair.
Although some of these issues currently run through pharmaceuticals and medical devices, many of
them, such as ownership of data,
security, and software updates, will
raise issues unique to pharmacoelectronic prescriptions.
Two chief concepts in medical
ethics relate to autonomy and nondecember 2015

maleficence, which together serve
as the basis for the right to privacy
and to one's liberty interest. Personal ownership, which is complete
interest and title to medical data,
and the power to enforce those
rights, assures that the data will
be used for its intended purpose.
Medical data, in contrast to medical
information, consists of electronic
data representations directly related to a patient (e.g., heartbeats or
doses of a prescription) as acquired
through a sensing device (e.g.,
pacemaker) or controlled through
a transducer. Medical data at the
patient level also includes transmission protocols, such as device
addresses, packet control data,
hash codes, and encryption keys.
The data may be parsed, so it exists
in various places, where medical
professionals can obtain access,
albeit that the charts authored by
doctors will remain medico-legal
records, and typically "owned" by
the medical professional.12 The difference between medical data and
medical information is more than
semantic. Although valid arguments
might be made as to the right of
a doctor to own a patient's medical record, our attention is drawn
to medical data, because it further
differentiates itself on the basis of:
1) the potential for non-medical
uses, 2) the seriousness of harm
that may occur in its misuse, and 3)
lack of present day protection for its
integrity, privacy and security."
The FDA monitors recalls on
products that contain errant components, including software, but
few instances have been reported
of Internet and software related
12
It will be interesting to see how this ownership
question develops. Medical providers typically
have claimed to own the information, because
they created it, use it, store it, and control it. As
this information goes to the "cloud," and both
storage and control belong to a third party, with
potentially liability for its release increasing,
medical professionals may not want to "own"
those records.

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IEEE Technology and Society Magazine

willful misconduct or malfeasance
resulting in bodily injury or death
[14]. Criminal activity, through the
use of computers including the
Internet, takes many forms that will
be applicable to in-the-body/telemetry devices and systems [15]-[24].
Unlike most computer hacking,
which generally invades privacy or
wrecks economic damage, hacking
an in-the-body device is potentially
lethal, as for example slowing down
or halting a pacemaker or commanding a defibrillator to deliver a
800-V deadly shock from a mobile
device several feet away [25]-[27].
However, currently little enforcement (state or federal) is apparent, if an individual is a victim of
software piracy, knockoff, unlawful
upgrade, hacking, or virus.
In addition to drugs and devices,
the U.S. FDA and the European Medicines Agency (EMA) deals with combination products, which include,
among other things, products largely
comprised of two or more regulated components, i.e., drug/device,
biologic/device, drug/biologic, or
drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and marketed as a
single product13 [28]. The FDA must
13

A combination product resides in the body
in the form of a computer control system for:
drug infusion, electrical excitation, or electronic
sensing as coupled to one or more of an electrical circuit, mechanical device, or drug delivery
apparatus.
14
There are numerous recalls related to malfunctions in medical devices with software
for example, on Mar. 6, 2013, the FDA Medical Recall Division, recalled the Alaris PC Unit
(Model 8015) with Software Version 9.12 manufactured by CareFusion Corporation. The Alaris
PC unit (model 8015) is part of the Alaris electronic infusion pump. An electronic infusion
pump delivers controlled amounts of medications or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other
acceptable routes of administration. The reason
for the recall was that the company received
reports of a communication error on the Alaris
PC unit (model 8015) with software version 9.12
when the Alaris EtCO2 module or Alaris SpO2
module is attached. It reported that the use of
the product may cause serious adverse health
consequences, including death. See, http://
www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm348983.htm.

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http://http:// http://www.fda.gov/MedicalDevices/Safety/ListofRe
Table of Contents for the Digital Edition of IEEE Technology and Society Magazine - December 2015
