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A letter report issued by the General Accounting Office with an abstract that begins "The Department of Health and Human Services issued a final regulation in December 2000 that established rights for patients with respect to the use of their medical records. The regulation requires that most providers obtain patient consent to use or disclose health information before engaging in treatment, payment, or health care operations. The privacy regulation's consent requirement will be more of a departure from current practice for some providers than for others. Most health care providers, with the exception of pharmacists, obtain some type of consent from patients to release information to insurers for payment purposes. The new requirement obligates most providers to obtain consent before they can use and disclose patient information. It also broadens the scope of consent to include treatment and a range of health care management activities. Supporters of the requirement believe that the process of signing a consent form provides an opportunity to inform and focus patients on their privacy rights. Others, however, are skeptical and assert that most patients will simply sign the form with little thought. In addition, provider and other organizations interviewed are concerned that the new consent requirement poses implementation difficulties. They contend that it could cause delays in filling prescriptions for patients who do not have written consents on file with their pharmacies, impede the ability of hospitals to obtain patient information prior to admission, hamper efforts to assess health care quality by precluding the use of patient records from years past, and increase administrative burdens on providers."

Medical privacy is a keystone of a free democratic society. To conserve the right of the patient to medical privacy, computerization of the medical data must be regulated. This paper enumerates some steps to be taken urgently for the protection of computerized sensitive medical data. A computer-oriented medical lexicon is urgently needed for accurate coding. Health industry standards should be drafted. The goals of various data centers must be sharply defined to avoid conflicts of interest. Medical privacy should be studied further, and medical data centers should consider cost-effectiveness. State boards for medical privacy should be created to monitor data security procedures. There is a need for purposeful decentralization. A national medical information policy should be drafted, and a national clinical information board should implement the nation's medical information policy.

In society, the family holds a special place among other social institutions. Family relations predetermine both the future of an individual and a whole generation in many respects. Therefore, from a medical point of view, the question of the health of spouses, children, and family as a whole continues to remain relevant. Premarital medical examination and open communication of the results is now being implemented only on a voluntary basis. Is such an approach able to protect the interests of both spouses and society, and how does it relate to the right of everyone to privacy and family secret? As part of the work, we studied the experience of foreign countries on the issue of medical examination of spouses and medical privacy of the examination results. In the domestic scientific literature, it is formed a position on the need for legislative consolidation of the mandatory mutual awareness of spouses regarding the results of a medical examination. Key words: Medical privacy, confidentiality, family law, marriage, spouse relations, personal non-property relations, information, medical examination.

The panel focused on the effects of current data privacy legislation. The panel discussed topics such as the history of data privacy regulation, the relationship between privacy and security, and corporate and government compliance with global data privacy regulations.

The release of Google glass and the Apple and Samsung smart watches in the past two years pushed wearables to the forefront of technology. The realm of medical wearables will specifically see a huge growth as wearables become more common place. There are documented cases of security and privacy breaches in the five main potential breaching areas: wearable device itself, Bluetooth communication, smartphone or personal computer app, Wi-Fi data exchange, cloud storage. Privacy policies for individual wearables are not always in the best interest of the individual and government regulations on wearables security does not always fully vet wearables. Interviews with industry professionals, both clinical and research, concluded that doctors are not very knowledgeable about wearables and are not very worried about security, the public does not understand security of these devices, and the security concerns should not stop the progress that is being made in this field.

This thesis focuses on the medical practice and legal regulation of medical scientific research with humans in medical emergency situations.

1. Introduction -- 2. Biometric technology and its applications -- 3. Rational concerns about biometric technology : security and privacy -- 4. Regulation of biometrics by privacy and data protection law in Europe -- 5. Biometrics and privacy protection in the United States -- 6. Privacy regulations on biometrics in Australia -- 7. Towards an appropriate regulatory approach for bio-privacy -- 8. Concluding remarks and future vision.

In conjunction with the Health Insurance Portability & Accountability Act (HIPAA), the US Dept of Health & Human Services (HHS) has created a plan to transcribe medical records into standard transactions using uniform codes & standard data elements. Under this new plan, personal medical histories could be easily accessed & abused if it were not for privacy standards enacted by the HHS in 2001. However, the effectiveness of the standards is suspect on the basis of terminology, eg, consent, authorization, & opportunities to object. Exceptions are found in which physicians & other covered entities -- health care providers, health plans, & health care clearinghouses -- are able to disclose medical information without the patient's consent. Further, the HHS is inadequate to control the redisclosure of medical records to recipients who are not covered entities. A pattern of misrepresentation & government manipulation, similar to the tactics used for Medicare in 1965, has turned unpopular measures into popular ones. The future prospects of privacy regulation is bleak as it has become less likely that the basic structure will change at the government's own initiative. 18 References. I. Sharp

PharmD ; Ranging from simple tongue depressors to heart valves and robotic surgery systems, medical devices are essential in the healthcare sector providing numerous benefits to the patient. Two new regulations from the European Commission, medical devices (MD) and in-vitro MD will come into force in May 2021 and May 2022 respectively. The study on medical devices could shed light on current practices in Malta and recommend improvements before the full implementation of the European Regulation on MD. The purpose of the study is (1) to set-up a MD database (DB) and (2) to improve the current incident reporting system for MD in the national healthcare system. The research, a prospective and interventional study, is divided into two sections. Section 1: Setting up of a MD database for the national competent authority (NCA). A review of the systems used by NCAs throughout the EU/EEA was conducted by contacting the MD competent authorities individually. The systems used throughout the EU/EEA were discussed in Focus Group A consisting of regulatory experts during which recommendations for the setup of MD DB were drawn up. The responses (n=12; 54.5%) from the European NCAs together with the recommendations resulting from the Focus Group A session were used to device the framework of (i) a DB for the registration of an entity and (ii) a DB for the registration of MD. Section 2: Analysis and update of the current incident reporting system for medical devices. Incident reports submitted at the national healthcare system by healthcare professionals (HCPs) in 2019 were collated in a database and analysed. Focus Group B, consisting of different experts, was set up to provide recommendations for the development of an improved incident reporting system. A total of 107 incidents originating from local hospitals (n=103; 96.3%), Pharmacy of your Choice Scheme (n=3; 2.8%), health centres (n=1; 0.9%) were submitted. Injury to patient/ operator was reported in 18 cases (16.8%). The most common types of MD reported in incidents were General and Plastic Surgery devices (n=48; 44.9%) and General Hospital Devices (n=22; 20.6%). Underreporting of MD incidents was identified. Barriers to MD incident reporting identified during Focus Group B include attitudes of HCPs, blame culture, legal liability, deficiencies in the MD procurement process, lack of training and education on MD incidents, recognition of MD incidents and deficiencies in the current reporting form. The results from Section 2 were used to propose a new Medical Device Incident Reporting Form (MDIRF). The areas identified for improvement in the new form were the addition of sections for (i) combination products, (ii) details on sample retention and (iii) addition of details for the description of injuries. Results from Focus Group A and responses from other NCAs indicated that a MD DB is crucial as part of the regulatory framework for MD. The results have shown that there is a low reporting of MD incidents (N=108 reports in 2019) and changes to the current system are warranted. Strengthening a safety culture based on lessons learnt and education between HCPs, in the context of MD incident reporting is proposed to improve patient and user safety. ; N/A

This study examines the impact of regulation as an antecedent of online privacy concern. Previous research found that perceived effectiveness and enforcement of regulatory policies reduce online privacy concern; however, it does not explain what factors influence this relationship. Based on the survey data, the empirical analysis is conducted on a large sample of internet users in Croatia. Our methodology consists of two parts: first, we use confirmatory factor analysis to validate the latent constructs used in the main model; and then we proceed with model estimation using OLS and ordered probit techniques. This study fills the gap in the existing body of knowledge by analysing different perceptions of the existing legislation and government effort to protect online privacy in the context of sociodemographic characteristics of respondents, computer anxiety, individual desire to maintain control of personal information online, as well as intensity and diversity of online activities. Our results indicate that perceived effectiveness of government regulation reduces online privacy concern whereas computer anxiety has a major positive impact on online privacy concern. These findings might be useful for national policy-makers and for business strategies, especially in the context of the GDPR regulation introduced in 2018

Advertisers use online customer data to target their marketing appeals. This has heightened consumers' privacy concerns, leading governments to pass laws designed to protect consumer privacy by restricting the use of data and by restricting online tracking techniques used by websites. We use the responses of 3.3 million survey takers who had been randomly exposed to 9,596 online display (banner) advertising campaigns to explore how privacy regulation in the European Union (EU) has influenced advertising effectiveness. This privacy regulation restricted advertisers' ability to collect data on Web users in order to target ad campaigns. We find that, on average, display advertising became far less effective at changing stated purchase intent after the EU laws were enacted, relative to display advertising in other countries. The loss in effectiveness was more pronounced for websites that had general content (such as news sites), where non-data-driven targeting is particularly hard to do. The loss of effectiveness was also more pronounced for ads with a smaller presence on the webpage and for ads that did not have additional interactive, video, or audio features.