Technology and Health Care 13 (2005) 193198 IOS Press

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When microchip implants do more than drug delivery: 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: bioethics@go.com
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 horizon for future patients. This paper presents ethical reection on these implants and identies specic areas of concern; namely, patient monitoring and tracking, and patient privacy and condentiality. It is foreseeable that drug delivery chips could be multifunctional 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 positioning satellite). Similarly, it is foreseeable that these chips could be embedded with a patients protected health information that could potentially be accessed and used by unauthorized persons. While drug delivery microchips are theoretically convenient and accurate for dosing, and might offer faster drug delivery with fewer side effects, ethical issues loom and should be contemplated now, while the technology is still under development. Keywords: Ethics, drug implant, privacy, condentiality, 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 occurs that releases estradiol for the treatment of menopausal hot ashes, night sweats, and vaginal dryness. GLIADEL Wafers (Guilford Pharmaceuticals Inc., Baltimore, MD) are small biodegradable carmustine implants 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 of biosensors which detect the appropriate time at which to dose each drug [17]. Features of this technology include 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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Fig. 1. Schematic of self regulating responsive therapeutic system gure used with permission of ChipRx, Inc. (Lexington, KY).

Researchers estimate that a dime-size microchip has enough surface area to accommodate over 1,000 reservoirs holding one or multiple drugs [16]. Each reservoir is potentially able to dispense its contents according to dened variables such as time, systemic concentration, or remote stimulation. This paper presents an ethical reection on drug delivery microchips and identies specic areas of concern; namely, patient monitoring and tracking, and patient privacy and condentiality. It is foreseeable that drug delivery chips could be multifunctional with the overt or covert addition of sensors that monitor more than just bloodstream concentrations of prescribed drugs. These concerns may sound like science ction; however, many medical technologies that were once the topics of science ction are now standard medical practice (e.g., organ transplantation, deep brain stimulation, photodynamic therapy), thus ethical reection during the development stage is critical. In general, ethical reection consists of attempting to balance the ethical principles of autonomy (respect for personal values), benecence (maximize patient benet), non-malfeasance (minimize patient harm), and justice (fairness) weighing the burdens and benets of the technology in question. Western society 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 these informed choices, patients need full disclosure as to the nature of the technology, and its risks and benets.

2. Ethical issues 2.1. Patient monitoring Microchip technology potentially enables drug delivery implants to do more than just release stored medication. It is foreseeable that these implants could also have concurrent overt or covert patient monitoring functions [9]. Consider a patient with La ennecs cirrhosis and a history of a failed alcohol treatment 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 transmits real-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 women receiving multivitamin microchips which concurrently monitor for the presence of ethanol and drugs of

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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 results could 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 conrmatory tests using gold standard assays of a different and more specic 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) denitions 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 inappropriate when 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 reects 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, drug delivery 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 tracking function (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 condentiality Due to the advances in computer technology, there is the potential for drug delivery microchips to be encoded with protected health information (PHI). According to the recently adopted United States Health Insurance Portability Act and Accountability Act of 1996 (HIPAA) [15], PHI is anything that can be used to identify an individual such as his/her name, Social Security Number, birth date, ngerprint, drivers license number, and hospital account number. Such encoding would render drug delivery specic to each patient for whom the chips are prescribed, by linking the chip with PHI. The concept of medical information on microchips was explored in the early 1990s in Belgium [3], and it is currently in a saleable form in several countries, including the United States [7]. At onset, the bundling of PHI onto microchips seems both helpful and convenient as chips could be scanned for prescribing accuracy before implantation; however, such encoding sets the stage for possible inappropriate 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 of pills; 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 under what circumstances. Further, it has been argued that patient privacy is still due in the case of prescription bottles that are disposed of; namely, the information contained on the label is not fair game for use by others [11]. Drug microchips are potentially scannable by unauthorized personnel without the knowledge and consent of the patient (e.g., scanned from a distance), thus PHI embedded in the chip could be viewed and 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 determine who accessed the information and when. This could make prosecuting such PHI theft very difcult. Even if only an individuals date of birth is accessible, this information combined with other items of information accessed in other ways, might together facilitate identity theft and fraud. One possible solution is to encrypt PHI. Another solution is to place minimal information within the chip and have the chip cross reference to a database that stores the majority of the patients PHI, and is accessible only by authorized personnel with unique security codes. 3. Discussion Control and consent are key principles in the discussion of the ethical issues with drug delivery microchips. This is because, as shown, there is the potential to bundle the task of drug delivery with other tasks such as patient monitoring, tracking, and identication. Because these other tasks can be done unobtrusively (concurrent with drug delivery), they are poised for intentional bundling for covert operation. 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 or consent. If the tasks are able to be triggered remotely, there is the possibility that patients would never fully 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 and privacy is alarming [10]. In theory, there are several options for microchip drug dosing control; namely, dosing remotely controlled by the patient, dosing remotely controlled by a clinician, or dosing controlled by the microchip via sensors that detect systemic conditions. Patient-controlled dosing using microchips would be similar

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to that of patient-controlled analgesia (PCA). With PCA, medication is dispensed via a pump attached to an intravenous line, which is inserted into a blood vessel in the patients hand or arm. Using a push button 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 tasks and medications that the patient may or may not have consented to (e.g., contraception, psychotropic medications). Forced treatment using a remotely triggered system [12] might be less stressful for patients and the health care team (especially if the chips can function for weeks or months), but it also 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 by unauthorized personnel with malicious intent. These concerns are valid in light of US federal interagency documents that describe biotechnology research projects intended to control humans without disclosure or 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 should reect upon the concepts of disclosure, consent, privacy, and condentiality. Patients should be informed of 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 identication, patient monitoring, and patient tracking. While drug chip technology may facilitate less stressful forced treatment, the route to gaining legal permission for forced treatment should remain intact, and not be bypassed due to the ease of microchip use. Further, individuals should retain their rights to privacy and condentiality 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 as it would for any other form of medical intervention. Having identied several ethical issues it is important to reect on the role of the US Food and Drug Administration (FDA) in evaluating these technologies for marketing approval. In reviewing clinical trial data, the FDA conducts both a scientic and regulatory review to evaluate the safety and effectiveness of the device in question (and the technologies incorporated into it). The FDA must approve each specic indication for product use, and the labeling of the product. This labeling includes use restrictions, and any relevant hazards, contraindications, side effects, and precautions. This said, the FDA has the authority to restrict how devices are used, and to require manufacturers to state in their product labeling the potential adverse consequences of their use. The FDA, thus, has a central role in determining what bundled drug chips 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 identied ethical dilemmas. 4. Conclusion Drug microchip technology has the potential to benet patients by delivering accurate, appropriately timed dosing, as well as site targeted dosing with reduced side effects. However, the act of microchip implantation can be viewed as bodily invasion [8], with the additional risks of privacy invasion when the chips are bundled with patient monitoring and tracking functions. While there is an ethically permissible role for bundled drug chips in the monitoring of patients who wander or elope due to cognitive dysfunction, monitoring chips have the potential to cross personal boundaries and result in harm, 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 be assumed that consent to microchip drug delivery equates to consent for other operational modes that these 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 legal reection is essential. Also, the technology must address matters of potentially severe and irreversible harm such as identity theft, discrimination, and the denial of medical care (e.g., transplantation) due to the reporting of invalid monitoring results. The FDA should consider these legal and ethical issues when evaluating bundled drug chips for marketing approval. Any new regulations that result should reect on ethics guiding principles, and the benets and burdens of the technology. Acknowledgement I thank Evan Topal for his literature research assistance. References
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