The need to know versus the right to know: privacy of patient medical data in an information-based society

"Whatever, in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret."(1) "Safeguards to privacy in individual health care information are imperative to preserve the health care delivery relationship and the integrity of the patient record."(2) As early as the fourth and fifth centuries B.C., Hippocrates contemplated the importance of medical information to the care and treatment of patients. His oath suggests that privacy of a patient's medical information creates the foundation upon which a patient reposes trust in his or her physician. While defining the earliest version of the physician-patient privilege, the oath does not envision the extent of modern day access to healthcare information. A patient's relationship with the modern healthcare delivery system often includes a team of physicians, nurses, and other clinical support personnel. This relationship extends beyond direct caregivers and may include healthcare administrators, payor organizations, and persons unfamiliar with a patient's identity, such as researchers and public health officials. Accessing a patient's medical information links these participants to the patient's healthcare delivery relationship. The Hippocratic Oath does not contemplate such broad access, nor does it contemplate the emerging privacy crisis resulting from the application of computer technology to medical record storage and retrieval. The combination of broad access, individual privacy rights, and computer technology requires a rethinking of measures designed to protect the realities of the modern medical information society.     

Medical regulation of cognitive enhancement devices: some concerns

The authors present a cogent and detailed case for altering the Medical Devices Directive to allow regulation of cognitive enhancement devices (CEDs). Protection against significant risk of harm, especially for the vulnerable, and promotion of benefit through informed use of CEDs are all good features of the proposal. However, the pre-market approval process has limitations, which we explore. We raise the possibility of ‘risk compensation’ in response to the introduction of safety measures, which could alter its effectiveness. The proposal alludes to use of ‘formally trained practitioners,’ which provide a further tier of regulation for CEDs within the proposal. We consider some positive and negative implications of this aspect of the proposal that might warrant further consideration.     

Patenting medical devices: the economic implications of ethically motivated reform

This article explores whether the current patent system strikes the optimal balance between providing incentives to inventors to bring new medical devices to the marketplace and promoting public health by ensuring that these medical devices are widely available at a reasonable price. After providing an overview of the relationship of patent law to medical devices, the author explains how ethical and economic considerations suggest the need for an alternative patent system for medical devices and notes the difficulties with this proposal. The author concludes that a combination of alternatives to the current system most equitably account for the interests and needs of both healthcare device consumers and producers.     

The regulation of cognitive enhancement devices: extending the medical model

This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions.     

Market introduction of innovative high risk medical devices: towards a recast of the directive concerning medical devices

The European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a "recast" of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA.     

Medical devices; medical device distributor reporting; opportunity for comments--FDA. Final rule; opportunity for comments

The Food and Drug Administration (FDA) is announcing an opportunity for public comments on the final rule on medical device distributor reporting, which is published elsewhere in this issue of the Federal Register. The medical device distributor reporting tentative final rule became final on May 28, 1992, by operation of the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments). Although not required to do so, FDA realizes that there may be issues not previously considered, such as technical issues on specific provisions, and therefore is providing this additional time for comment. If changes are warranted by comments, FDA will make further changes in the rules.     

Medical devices: classification of the dental sonography device and jaw tracking device. Final rule

The Food and Drug Administration (FDA) is classifying the dental sonography device into class I, when it is used to monitor temporomandibular joint sounds, and into class II, when it is used to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. FDA is classifying the jaw tracking device into class I, when it is used to monitor mandibular jaw positions relative to the maxilla, and into class II, when it is used to interpret mandibular jaw positions relative to the maxilla, for the diagnosis of temporomandibular joint disorders and associated orofacial pain. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).     

The attack on national regulation: why we need a global framework for domestic regulation

The first 150 words of the full text of this article appear below. Key points

• In regulating cross-border capital markets transactions,regulators are employing either an exemptive approach, or aunilateral or mutual recognition approach. The exemptive approachallows market participants wherever located to transact businessin the host countries without complying with local requirements.The recognition approach is limited to a particular market,but is more expansive in terms of access to host country investors.In regulating cross-border transactions, the SEC has traditionallyrelied on the exemptive approach, and has restricted participationto only the largest, most sophisticated US investors. Recently,it has moved to a mutual recognition approach with its agreementwith Australia, which allows a broader range of US investorsto conduct cross-border transactions with Australian exchangesand broker–dealers relying almost entirely on the adequacyof the Australian regulatory system. However, both its exemptiveapproach and mutual recognition approach deal only with secondarymarket transactions, not participation in offerings.
• While. . . [Full Text of this Article]