article of american literature

7/27/2019 Article of American Literature

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Technology and Health Care 13 (2005) 193198 193IOS Press

When microchip implants do more than drugdelivery: Blending, blurring, and bundling of

protected health information and patient

monitoring

Katrina A. Bramstedt

Department of Bioethics, General Clinical Research Center Research Subject Advocacy Program,Cleveland Clinic Foundation, Cleveland Clinic Lerner College of Medicine, 9500 Euclid Ave., mailcode

NA-10, Cleveland, OH 44195, USA

Tel.: +1 216 444 8720; Fax: +1 216 444 9275; E-mail: [email protected]

Received 3 August 2004

Accepted 12 October 2004

Abstract. Although currently in the research stage, scientists argue that drug-releasing microchip implants are on the horizonfor future patients. This paper presents ethical reflection on these implants and identifies specific areas of concern; namely,patient monitoring and tracking, and patient privacy and confidentiality. It is foreseeable that drug delivery chips could bemultifunctional with the overt or covert addition of sensors that monitor more than just the bloodstream concentrations of

prescribed drugs (e.g., cotinine and alcohol in non-compliant patients, patient location via radio frequency or global positioningsatellite). Similarly, it is foreseeable that these chips could be embedded with a patients protected health information that couldpotentially be accessed and used by unauthorized persons. While drug delivery microchips are theoretically convenient andaccurate for dosing, and might offer faster drug delivery with fewer side effects, ethical issues loom and should be contemplatednow, while the technology is still under development.

Keywords: Ethics, drug implant, privacy, confidentiality, monitoring

1. Introduction

Drug releasing implants are not new to the practice of medicine, and the technology of these implants

continues to evolve. Femring (Warner Chilcott PLC, Rockaway, NJ) is a vaginal ring containing a

central core of active drug. When Femring is inserted into the vagina, a conversion process occursthat releases estradiol for the treatment of menopausal hot flashes, night sweats, and vaginal dryness.GLIADEL Wafers (Guilford Pharmaceuticals Inc., Baltimore, MD) are small biodegradable carmustineimplants placed at the site where brain tumors have been excised in an effort to deliver chemotherapy

directly to the resultant cavity. Currently in the development stage, drug delivery microchips (subdermal,spine, and brain implants) have the potential to store and release multiple medications under the control ofbiosensors which detect the appropriate time at which to dose each drug [17]. Features of this technologyinclude small device size, low or no power requirements, and no moving parts (Fig. 1).

0928-7329/05/$17.00 2005 IOS Press and the authors. All rights reserved


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194 K.A. Bramstedt / When microchip implants do more than drug delivery

Fig. 1. Schematic of self regulating responsive therapeutic system figure used with permission of ChipRx, Inc. (Lexington,KY).

Researchers estimate that a dime-size microchip has enough surface area to accommodate over 1,000reservoirs holding one or multiple drugs [16]. Each reservoir is potentially able to dispense its contents

according to defined variables such as time, systemic concentration, or remote stimulation. This paper

presents an ethical reflection on drug delivery microchips and identifies specific areas of concern;namely, patient monitoring and tracking, and patient privacy and confidentiality. It is foreseeable that

drug delivery chips could be multifunctional with the overt or covert addition of sensors that monitormore than just bloodstream concentrations of prescribed drugs. These concerns may sound like science

fiction; however, many medical technologies that were once the topics of science fiction are now standard

medical practice (e.g., organ transplantation, deep brain stimulation, photodynamic therapy), thus ethical

reflection during the development stage is critical.In general, ethical reflection consists of attempting to balance the ethical principles of autonomy

(respect for personal values), beneficence(maximize patient benefit), non-malfeasance (minimize patient

harm), and justice (fairness) weighing the burdens and benefits of the technology in question. Westernsociety generally accepts that patients with decision-making capacity should be allowed to make informed

consent or informed refusal of proposed medical care, but as will be discussed, in order to make theseinformed choices, patients need full disclosure as to the nature of the technology, and its risks and

benefits.

2. Ethical issues

2.1. Patient monitoring

Microchip technology potentially enables drug delivery implants to do more than just release storedmedication. It is foreseeable that these implants could also have concurrent overt or covert patient

monitoring functions [9]. Consider a patient with Laennecs cirrhosis and a history of a failed alcoholtreatment program who is placed on the waiting list for a liver transplant. Pharmacotherapy could be

provided to the patient via a drug delivery implant which also has an ethanol sensor that transmitsreal-time readings to the clinical team. The same could be envisioned in the form of cotinine sensors on

the drug implant chips of those on lung transplant waiting lists. One could also imagine pregnant womenreceiving multivitamin microchips which concurrently monitor for the presence of ethanol and drugs of


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K.A. Bramstedt / When microchip implants do more than drug delivery 195

abuse such as cocaine. Such monitoring could be easily accomplished without patient knowledge, as it is

a non-invasive task done in tandem with the drug delivery function for which the patient has consented.

Using sensors to detect non-compliance or inappropriate behavior could be viewed as ethically

problematic, especially if such monitoring generates invalid test results. Incorrect monitoring resultscould have potentially severe consequences. For example, positive drug or alcohol results could result

in a potential transplant patient being removed from an organ waiting list. Similarly, such results could

place a pregnant woman at risk of legal action due to fetal endangerment [13]. To prevent unjust actions

that may have irreversible mental or clinical consequences, the health care team should always run

confirmatory tests using gold standard assays of a different and more specific chemical method (e.g.,

gas chromatography/mass spectrometry). All biomonitoring tasks should be thoroughly validated, and

device production methods should ensure consistently safe and effective product.

Patient monitoring also raises the issue of the sometimes subjective nature of the ground rules; that

is, the potential for unjust (or even unclear or variable) definitions of non-compliance or inappropriate

behavior to be employed [2]. Clearly, failure to adhere to a low salt diet is an example of non-compliance,

but there is often disagreement about alcohol use, for example. Is one glass of red wine daily inappropriatewhen some clinicians recommend such a practice to their patients? [6] Is a patient truly non-compliant

when failure to adhere to his/her medication regimen is due to the suffering of adverse side effects, or if

the reason for missing dialysis appointments is the lack of reliable transportation? In advance of starting

any biomonitoring program, the ground rules need to be clearly stipulated, accepted by the medical

team and understood by the patient. Patient compliance can be enhanced when the team reflects on the

patients unique circumstances and actively involves the patient in medical decision-making through a

treatment alliance that is based on compassion rather than threats [14].

2.2. Patient tracking (human surveillance)

Drug delivery could also be overtly or covertly bundled with patient tracking [5]. For example, drugdelivery microchips could contain radio frequency or global positioning satellite tracking technology

that could monitor the location of implanted patients. Such multifunctional implants could be targeted

to patient populations at risk of wandering (e.g., Alzheimers disease, dementia) or losing consciousness

(e.g., epilepsy). Patient tracking might also be helpful in the inpatient setting so that the location of

patients could always be known (e.g., patient at hydrotherapy, at the cafeteria). These dual function

microchips could also be helpful in locating patients who elope from the hospital.

As in the case of covert video monitoring in an attempt to diagnose Munchausen Syndrome by Proxy,

clinicians can assume a secondary police role [4]. Further, tracking is ethically problematic when

medical rationale are used to track humans for non-medical (e.g., legal) purposes. It is possible that

all drug delivery microchips could be manufactured with a bundled tracking function that can be turned

on or off according to need. This sets the stage for questions such as, who can activate this trackingfunction (e.g., clinician, judge, manufacturer), under what circumstances [need] can the function be

activated, and under what circumstances is disclosure and consent required for activation. One solution

is to market and implant medical and legal chips as discretely separate entities, with medical chips

not allowed to serve legal and other non-medical functions. Under these circumstances, medical

chips would ensure that clinicians maintain their medical role of prescribing and treatment, and do not

assume a role in policing humans.


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2.3. Patient privacy and confidentiality

Due to the advances in computer technology, there is the potential for drug delivery microchips to beencoded with protected health information (PHI). According to the recently adopted United States HealthInsurance Portability Act and Accountability Act of 1996 (HIPAA) [15], PHI is anything that can be usedto identify an individual such as his/her name, Social Security Number, birth date, fingerprint, driverslicense number, and hospital account number. Such encoding would render drug delivery specific toeach patient for whom the chips are prescribed, by linking the chip with PHI. The concept of medicalinformation on microchips was explored in the early 1990s in Belgium [3], and it is currently in a saleableform in several countries, including the United States [7].

At onset, the bundling of PHI onto microchips seems both helpful and convenient as chips could bescanned for prescribing accuracy before implantation; however, such encoding sets the stage for possibleinappropriate access and misuse of PHI. An argument could be made that encoding a patients name

within his/her drug microchip is no different from a pharmacist placing a prescription label on a bottle ofpills; however, in the latter case, the pill bottle is in the control of the patient and access to the labeling

information is controlled by the patient because he/she decides to whom to show the bottle, and underwhat circumstances. Further, it has been argued that patient privacy is still due in the case of prescriptionbottles that are disposed of; namely, the information contained on the label is not fair game for use byothers [11].

Drug microchips are potentially scannable by unauthorized personnel without the knowledge andconsent of the patient (e.g., scanned from a distance), thus PHI embedded in the chip could be viewedand used for unauthorized purposes. Information stolen in this manner could result in identity theft,fraud, discrimination, or other forms of harm. Complicating matters, it might be impossible to determinewho accessed the information and when. This could make prosecuting such PHI theft very difficult.Even if only an individuals date of birth is accessible, this information combined with other items ofinformation accessed in other ways, might together facilitate identity theft and fraud. One possiblesolution is to encrypt PHI. Another solution is to place minimal information within the chip and have thechip cross reference to a database that stores the majority of the patients PHI, and is accessible only byauthorized personnel with unique security codes.

3. Discussion

Control and consent are key principles in the discussion of the ethical issues with drug deliverymicrochips. This is because, as shown, there is the potential to bundle the task of drug delivery withother tasks such as patient monitoring, tracking, and identification. Because these other tasks can bedone unobtrusively (concurrent with drug delivery), they are poised for intentional bundling for covertoperation. Even if the patient were informed about these bundled tasks, and declined to consent to them,

there is the possibility that the tasks could be conducted anyway, without the patients knowledge orconsent. If the tasks are able to be triggered remotely, there is the possibility that patients would neverfully know what their chips were/were not doing, as chip functions could be turned on and off covertly.In the case of brain implants, some have argued that the potential for sinister invasions of liberty andprivacy is alarming [10].

In theory, there are several options for microchip drug dosing control; namely, dosing remotelycontrolled by the patient, dosing remotely controlled by a clinician, or dosing controlled by the microchipvia sensors that detect systemic conditions. Patient-controlled dosing using microchips would be similar


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K.A. Bramstedt / When microchip implants do more than drug delivery 197

to that of patient-controlled analgesia (PCA). With PCA, medication is dispensed via a pump attachedto an intravenous line, which is inserted into a blood vessel in the patients hand or arm. Using a pushbutton mechanism, the patient is allowed to self-administer doses of pain relieving medication as needed.

Overdose is prevented via a security feature of the pump device.Remotely controlled dosing by clinicians raises the potential issue of chips bundled with other tasksand medications that the patient may or may not have consented to (e.g., contraception, psychotropicmedications). Forced treatment using a remotely triggered system [12] might be less stressful forpatients and the health care team (especially if the chips can function for weeks or months), but italso raises the issues of disclosure and consent. Also, without a mechanism for overdose prevention,there could even be the possibility of patients being intentionally killed if remote access was gained byunauthorized personnel with malicious intent. These concerns are valid in light of US federal interagencydocuments that describe biotechnology research projects intended to control humans without disclosureor consent [1].

Technical matters aside (e.g., drug dosing accuracy in the presence of multiple drugs on one chip,correct sequence for dosing multiple drugs, prevention of reservoir leakage and rupture), ethical guidance

for the use of microchip drug delivery devices is essential. To this end, microchip prescribing shouldreflect upon the concepts of disclosure, consent, privacy, and confidentiality. Patients should be informedof all the attributes of their prescribed chips, including what modes of their chips are active, inactive,and potentially active. These modes include, but are not limited to, drug delivery, patient identification,patient monitoring, and patient tracking. While drug chip technology may facilitate less stressful forcedtreatment, the route to gaining legal permission for forced treatment should remain intact, and not bebypassed due to the ease of microchip use. Further, individuals should retain their rights to privacy andconfidentiality in the presence of drug chips that may encode their personal information. Additionally,drug chip technology should not erode the requirement of informed consent; such should be obtained asit would for any other form of medical intervention.

Having identified several ethical issues it is important to reflect on the role of the US Food and DrugAdministration (FDA) in evaluating these technologies for marketing approval. In reviewing clinical trialdata, the FDA conducts both a scientific and regulatory review to evaluate the safety and effectiveness ofthe device in question (and the technologies incorporated into it). The FDA must approve each specificindication for product use, and the labeling of the product. This labeling includes use restrictions, and anyrelevant hazards, contraindications, side effects, and precautions. This said, the FDA has the authority torestrict how devices are used, and to require manufacturers to state in their product labeling the potentialadverse consequences of their use. The FDA, thus, has a central role in determining what bundled drugchips will and will not be allowed to do (chip functions and indications), and thus has a role in creating,implementing, and enforcing solutions to the identified ethical dilemmas.

4. Conclusion

Drug microchip technology has the potential to benefit patients by delivering accurate, appropriatelytimed dosing, as well as site targeted dosing with reduced side effects. However, the act of microchipimplantation can be viewed as bodily invasion [8], with the additional risks of privacy invasion whenthe chips are bundled with patient monitoring and tracking functions. While there is an ethicallypermissible role for bundled drug chips in the monitoring of patients who wander or elope due tocognitive dysfunction, monitoring chips have the potential to cross personal boundaries and result inharm, including distrust of the medical profession.


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Certainly, receiving medical care can mean giving up a portion of ones privacy, but it should not beassumed that consent to microchip drug delivery equates to consent for other operational modes thatthese devices may concurrently offer. Further, controlled drug delivery could equate to forced drug

treatment in some situations (e.g., patients who are noncompliant or mentally ill), thus ethical and legalreflection is essential. Also, the technology must address matters of potentially severe and irreversibleharm such as identity theft, discrimination, and the denial of medical care (e.g., transplantation) due tothe reporting of invalid monitoring results. The FDA should consider these legal and ethical issues whenevaluating bundled drug chips for marketing approval. Any new regulations that result should reflect on

ethics guiding principles, and the benefits and burdens of the technology.

Acknowledgement

I thank Evan Topal for his literature research assistance.

References

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Medical Informatics (London) 17 (1992), 257267.[4] R. Connelly, Ethical issues in the use of covert video surveillance in the diagnosis of Munchausen syndrome by proxy:

the Atlanta study an ethical challenge for medicine, HEC Forum 15 (2003), 2141.[5] Digital Angel Corporation, Digital Angel Miniaturizes GPS Transmitting Technology, Press Release, South St. Paul, MN,

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Center Report18 (1988), 4146.[9] T.K. Li, Statement on Fiscal Year 2004 Presidents Budget Request for the National Institute on Alcohol Abuse and

Alcoholism, April, 2003. Available at: http://www.niaaa.nih.gov/about/statement03.htm, Accessed 12 April, 2004.[10] G.C. Maguire Jr. and E.M. McGee, Implantable brain chips? Time for debate, Hastings Center Report29 (1999), 713.[11] G.T. Marx, An ethics for the new surveillance, The Information Society 14 (1998), 171186.[12] Massachusetts Institute of Technology, Smart drug delivery helps patients stay on treatment, MIT Tech Talk48 (2004),

2.[13] McKnight v. South Carolina, 124 S. Ct. 101.[14] Mid-Atlantic Renal Coalition, Working with Noncompliant and Abusive Patients, Midlothian, VA, January, 1994.[15] Public Law 104191, Health insurance portability and accountability act of 1996, Federal Reg 64 (1999), 60053.[16] J.T. Santini Jr., M.J. Cima and R. Langer, A controlled-release microchip, Nature 397 (1999), 335338.[17] J.T. Santini Jr., A.C. Richards, R.A. Scheidt, M.J. Cima and R.S. Langer, Microchip technology in drug delivery, Annals

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