Wireless medical telemetry service. Federal Communications Commission. Final rule

This document allocates new spectrum and establishes rules for a Wireless Medical Telemetry Service (WMTS) that allows potentially life-critical equipment to operate on an interference-protected basis. Medical telemetry equipment is used in hospitals and health care facilities to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. This action will increase the reliability of medical telemetry equipment.     

Medicare and Medicaid program; regulatory provisions to promote program efficiency, transparency, and burden reduction. Final rule

This final rule identifies reforms in Medicare and Medicaid regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries. This rule increases the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care. This is one of several rules that we are finalizing to achieve regulatory reforms under Executive Order 13563 on Improving Regulation and Regulatory Review and the Department's Plan for Retrospective Review of Existing Rules.     

Payment method for health care services under the Supplemental Health Care Program for Active Duty Members of the Uniformed Services; adoption of CHAMPUS procedures--DoD. Final rule

This final rule partially implements 10 U.S.C. 1074(c), as amended by section 729 of the National Defense Authorization Act for Fiscal Years 1990 and 1991, Public Law 101-189. The recent amendment authorizes the Department of Defense to establish for the active duty supplemental care program payment rules similar to those used under the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). The supplemental care program is the program which provides for the payment to civilian (non federal-governmental) health care providers for care provided to active duty members of the uniformed services. This final rule would adopt CHAMPUS payment amounts for the supplemental care program.     

Choosing to limit choice: Self-binding directives in Dutch mental health care

In certain cases of chronic mental illness (for example bipolar disorder) a self-binding directive or Ulysses contract may be a helpful intervention to prevent harm to the person him- or herself and/or others. By choosing such an arrangement, the patient can indicate when and how mental health professionals may intervene against his or her will and provide indicated care which may lead to an improvement of the patient's mental condition. In the Netherlands, since 2008 the Compulsory Admissions Act has been amended and now includes a paragraph on self-binding. Starting from the Dutch debate and statutory regulation of self-binding in mental health care, a number of issues with broader relevance are discussed, particularly as these pertain to the legal regulation and juridification of self-binding. It is argued that too many detailed rules are a threat to increasing patient empowerment.     

Medicare program; Medicare Economic Index update for 1991--HCFA. Notice

This notice updates the Medicare Economic Index (MEI), which is used to calculate the prevailing charge levels that help to determine reasonable charges for certain physician services under the Medicare Supplementary Medical Insurance (part B) program. As mandated by section 4105 of Public Law 101-508, for physician services furnished on or after January 1, 1991, and before January 1, 1992, the increase for primary care services will be 2 percent. There will be no increase for all other physician services.     

The semblance of autonomy: treatment of persons with disabilities under the Uniform Health-Care Decisions Act

This Article illuminates the dangers of the Uniform Health-Care Decisions Act, which provides a set of model rules designed to clarify and expedite end-of-life health-care decisionmaking for incapacitated patients. The uniform commissioners and many scholars who have commented on the Act have touted the legislation as a model for defending patient autonomy. As this Article will reveal, the impression of autonomy is an illusion. In fact, the Act privileges the perspectives of the able-bodied over those of persons with disabilities, endangers the autonomy of incapacitated patients, and empowers proxy decisionmakers who have incentives to terminate treatment. These risks have become all the more significant with the rise of managed-care programs that create pressures to minimize care. After highlighting the serious risks to vulnerable patients under the Uniform Health-Care Decisions Act, the Article offers alternative rules and stronger safeguards to better protect patient autonomy and defend against wrongful health-care decisions. This Article urges states seeking improved end-of-life health-care procedures to codify these or similar protections in order to avoid the lethal shortcomings of the Uniform Health-Care Decisions Act.     

Towards Europeanisation through the proportionality test? The impact of free movement law on medical professional discipline

Medical doctors can exercise their free movement rights to escape the control of professional regulation at the national level. This “darker side” of free movement of doctors has received a lot of attention. This article will show that the free movement provisions play an increasingly important role in medical disciplinary cases. The application of free movement law can make a positive contribution to the protection of patient safety. However, disciplinary tribunals are unfamiliar with the structure of arguments based on the free movement provisions. While the case law on free movement of patients has encouraged a process of internationalisation of medical standards, free movement of doctors has not yet led to a similar process of Europeanisation of medical professional rules. Nevertheless, the proportionality test requires that disciplinary tribunals engage in a process of comparison between their own rules and the rules in other Member States.     

Medically futile care: the role of the physician in setting limits.

In an effort to clarify the concept of "medically futile care," two types of futile care are identified: 1) care that produces no demonstrable effect; and 2) care that produces an effect that is believed by the speaker to be of no net benefit. It is the second type of futile care, when a patient or surrogate and the clinician disagree over the benefit that the patient will receive from an intervention, that is most interesting morally and that cannot properly be labelled medically futile. As such, decisions to limit access to care deemed futile should not rest with medical professionals. This Article argues for a limited duty of clinicians to provide life-prolonging and some other fundamental care that is equitably funded and desired by the patient while competent, even if the clinician believes that such interventions will produce no net benefit.     

Establishment of a Medical Implant Communications Service in the 402-405 MHz band. Federal Communications Commission. Final rule

This document establishes a Medical Implant Communications Service (MICS) operating in the 402-405 MHz band. MICS operations will consist of high-speed, ultra-low power, non-voice transmissions to and from implanted medical devices such as cardiac pacemakers and defibrillators. The rules will allow use of newly-developed, life-saving medical technology without harming other users of the frequency band.     

Medicare program; establishment of Medicare Economic Index effective April 1, 1990--HCFA. Notice

This notice updates the Medicare Economic Index (MEI), which is used to calculate the prevailing charge levels that help to determine reasonable charges for certain physician services under the Medicare Supplementary Medical Insurance (Part B) program. For physician services furnished on or after April 1, 1990, and before January 1, 1991 the increase for primary care services will be 4.2 percent, and for other services it will be 2.0 percent.     

Collection from third party payers of reasonable costs of healthcare services--DoD. Final rule

This final rule establishes a new rule under the Third Party Collection program for determining the reasonable costs of health care services provided by facilities of the uniformed services in cases in which care is provided under TRICARE Resource Sharing Agreements. For purposes of the Third Party Collection program such services will be treated the same as other services provided by facilities of the uniformed services. The final rule also lowers the high cost ancillary threshold value from $60 to $25 per 24-hour day for patients that come to the uniformed services facility for ancillary services requested by a source other than a uniformed services facility. The reasonable costs of such services will be accumulated on a daily basis. The Department of Defense is now implementing TRICARE, a major structural reform of the military health care system, featuring adoption of managed care practices in military hospitals and by special civilian contract provider networks. Consistent with TRICARE, as part of the Third Party Collection Program, DoD is transitioning to a billing and collection system in which all costs borne by DoD Medical Treatment Facilities (MTFs) will be billed by the MTF providing the care. Thus, all care performed within the facility, plus an added amount for supplemental care purchased by the facility, will be billed by the MTF. Conversely, care provided outside the MTF under other arrangements will be billed by the provider of that care.     

The Olympics: 64 years on

In just over a month's time London will be the centre of international focus as athletes from over 200 countries arrive for the Olympic Games. The last Olympic Games held in London was in 1948 – in the same month the National Health Service (NHS) was established. It is a tragic coincidence that the Olympics returns to London in the same year as the Health and Social Care Act was passed, legislation the chairman of the British Medical Association described as likely to be ‘irreversibly damaging to the NHS as a public service, converting it into a competitive marketplace that will widen health inequalities and be detrimental to patient care’ (Buckman, 2012).     

Cardiac Implantable Medical Devices forensics: Postmortem analysis of lethal attacks scenarios

Cardiac Implantable Medical devices (IMD) are increasingly being used by patients to benefit from their therapeutic and life-saving functions. These medical devices are surgically implanted into patient's bodies and wirelessly configured by prescribing physicians and healthcare professionals using external programmers. However, these devices are threatened by a set of lethal attacks, due to the use of vulnerable wireless communication and security protocols, and the lack of security protection mechanisms deployed on IMDs.In this paper, we propose a digital investigation system for the postmortem analysis of lethal attack scenarios on cardiac IMDs. After developing a set of techniques allowing the secure storage of digital evidence logs which track the executed sensitive events, we implement an in-depth security solution allowing the protection of cardiac IMDs. An inference system integrating a library of medical rules is proposed to automatically infer potential medical scenarios that caused the patient's death, or that created heart-related emergency situations (through the occurrence of ventricular tachycardia for example). A Model Checking based formal technique to reconstruct potential technical attack scenarios on a cardiac IMD, starting from the collected evidence, is also proposed. The results obtained by the two proposed reasoning techniques (i.e., the inference system and the Model Checking based algorithm) are correlated to prove whether a potential attack scenario is responsible of the occurrence of heart-related emergency situations or the death of a patient. Based on the proposed techniques, we design a decision-support system that reconciles in the same framework the medical and technical investigation aspects.     

医患关系的形成与扩展:对美国法上几则新近案例的释读

在美国法中,存在医患关系是主张医疗损害赔偿的一个先决条件。医患关系是一种基于双方自愿的契约关系。医生没有直接接触患者并不妨碍医患关系的建立,医疗建议可以启动医患关系。与一个想分娩健康婴儿的孕妇形成医患关系的医生也与胎儿形成了医患关系。与医生这一职业人员存在相互关系的人可包括没有与职业人员建立严格/直接的契约关系的人群。医生的注意义务可扩展到与其不存在直接的医患关系但存在特殊关系的非患者。如果通行的注意标准所创设的义务明显有益于某些可以确定的第三方,该第三方处于可预见的危险区域,而医生知道此类第三方的存在,那么医生的义务将指向该第三方。当医生仅仅提供检查而没有对受雇者提供医疗和照护时,医生与被检查人员之间不存在医患关系。     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); specialized treatment services; nonavailability statements; peer review organization program; supplemental care--DoD. Final rule

This final rule: establishes a Specialized Treatment Services Program, under which CHAMPUS beneficiaries in need of certain highly specialized medical care will be referred to specially designated national or regional, military or civilian treatment facilities; revises a number of procedures applicable to the CHAMPUS Peer Review Organization program; and expands reliance on CHAMPUS payment rules and procedures for purposes of the supplemental care program, which applies to services provided by civilian providers to active duty members and certain other patients referred by military providers.     

Standards for privacy of individually identifiable health information. Office of the Assistant Secretary for Planning and Evaluation, DHHS. Final rule

This rule includes standards to protect the privacy of individually identifiable health information. The rules below, which apply to health plans, health care clearinghouses, and certain health care providers, present standards with respect to the rights of individuals who are the subjects of this information, procedures for the exercise of those rights, and the authorized and required uses and disclosures of this information. The use of these standards will improve the efficiency and effectiveness of public and private health programs and health care services by providing enhanced protections for individually identifiable health information. These protections will begin to address growing public concerns that advances in electronic technology and evolution in the health care industry are resulting, or may result in, a substantial erosion of the privacy surrounding individually identifiable health information maintained by health care providers, health plans and their administrative contractors. This rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.     

Medical: advance health care planning. Final rule

This document amends VA medical regulations to codify VA policy regarding advance health care planning. The final rule sets forth a mechanism for the use of written advance directives, i.e., a VA living will, a VA durable power of attorney for health care, and a State-authorized advance directive. The final rule also sets forth a mechanism for honoring verbal or non-verbal instructions from a patient when the patient is admitted to care when critically ill and loss of capacity may be imminent and the patient is not physically able to sign an advance directive form, or the appropriate form is not readily available. This is intended to help ensure that VA acts in compliance with patients' wishes concerning future health care.     

Creation of the Emergency Medical Radio Service--FCC. Final rule

The Commission has adopted rules that create the Emergency Medical Radio Service. This action was taken to redress the adverse consequences on public health and safety resulting from current crowding on emergency medical channels. The rule changes will establish a discrete radio service category dedicated strictly to eligibles providing basic or advanced life support services on an ongoing basis and thereby ensure the reliability of emergency medical communications.     

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.