IEEE Technology and Society Magazine - December 2015 - 38

or neurological diseases, such as
Parkinson's disease; f) to transmit physiological data, such as
obtained from electrocardiograms9
and ultrasonic devices at the pointof-emergency with telecommunication [11].
The pacemaker represents the
most widely deployed example of
an implantable/telecommunicating medical device. It comprises
a working silicon-based computer, with sensors, memories, and a
stimulation device with telecommunications to the outer world.
Doctors install the conventional
product beneath the flesh above
the outer chest with leads that
fix to the inner heart wall. The
device paces the heart and may
be combined with a cardioverter/
defibrillator. The latest innovation by passes the outer chest
wall. The size of a large antibiotic capsule, physicians insert the
pacer through the femoral artery
leading to the heart's cavity. The
device requires no interconnecting wires, but lodges via a "grappling hook" to the heart's inner
wall where it stimulates the heart.
Technologists project an eventual downsizing on the order of
a grain of rice and diminution in
power requirements to the point
where energ y scavenged from
the body's metabolic processes someday will keep the pacemaker's micro-circuitry powered
indefinitely.
In the family of pacemaker-like
devices, the science of neurological
stimulators has emerged, such as
bone growth stimulators, and drug
delivery systems for insulin or pain
medication, which additionally typically include a pump, which stores
and infuses a drug at a selected rate
through a catheter to the desired
9

See [10], Tele-diagnostic device, for collecting
diagnostic information and transmitting the
diagnostic information to a remote location.

location.10 Other neurological stimulators provide for "deep brain
stimulation," to treat depression
and bradykinesia (slow movement)
associated with Parkinson's disease,
where electrodes are implanted in
the subthalamic region of the brain.
The wire ends are placed beneath
the scalp and an impulse generator
placed in the chest. These treatments
address not only tremors, but the full
range of the symptoms, including:
rigidity, slow movement, stiffness,
and walking concerns. Medical technicians can adjust the device parameters remotely, via a telecom link.
Intelligent medicines, or chip-inthe-pill technology, offer yet another family of devices, roughly the
size of a grain of sand. In the early
1960s, the Konigsberg telemetry
pill was first ingested by patients
to record their temperature and
transmit the data to a receiver for
analysis. In 1991, Jerome Schentag invented a pill that when swallowed was tracked as it progressed
through the alimentary tract, and
upon reaching a specific site, was
remotely triggered to release medication. More recently, the FDA
approved a pill that when swallowed
transmits to a receiver (a sensing
patch on the patient's shoulder)
to report when a prescription has
been ingested. Such chip-in-the-pill
products can also measure heart
rate and respiratory patterns using
circuitry run on a charge generated by a patient's stomach acid.
The data, transmitted through the
patient's mobile phone or tablet,
allows a caregiver or patient to view
when the patient ingested a chip
and when the medication started to
metabolize. Other similar technolo-

gies contain cameras capable of
revealing colon tumors.

Legal Corollaries of Systems
of Pharmaco-Electronics
Unlike pharmaceuticals, in-the-body
electronic medicine deals with a
complex system of distributed elements: an embedded device, a communications network that includes a
local intermediary receiver/transmitter (e.g., smartphone, modem, and
telephone line interface), a remote
computer, software at every level,
databases (often in the "cloud"),
automated decision making, and,
finally, the all-important pharmacoelectronic prescription.
Although impossible in this
space to discuss the rights, duties,
obligations and liabilities associated
with pharmaco-electronic prescriptions, the compendium of torts,
actions in contract, including medical malpractice, and product liability for pharmaceuticals and medical
devices generally apply to in-thebody medical devices.11 Electronic
medicine is related to pharmacology generally and more directly to
medical devices as goes its intended effects, and we look to legal
precedent as developed in these
areas. For example, The U.S. Federal Food, Drug, and Cosmetic Act,
52Stat. 1040, as amended, 21 U.
S. C. §301 et seq. (Medical Device
Amendments of 1976 ("MDA")),
requires FDA approval for the introduction of new drugs and medical
devices. In 2008, the U.S. Supreme
Court considered whether the preemption clause enacted in §360k
of the MDA prohibited common-law
claims challenging the safety and
effectiveness of a medical device
after premarket approval by the

10
Medtronics, Inc., developed the IsoMed Constant-Flow Infusion System for bodily implantation that provides intrathecal infusion of
morphine sulfate solution in the treatment of
chronic intractable pain, or the intravascular
infusion of floxuridine for the treatment of primary or metastatic cancer.

IEEE Technology and Society Magazine

11
For example, in Januar y, 2007 Medtronic,
a leader in pacemaker technology, reported
five patient deaths. The FDA has 599 reports
of malfunctions and injuries associated with
fractured leads. Suits followed and Medtronic
settled most of the cases.

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december 2015

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