Michael Murphy, Compliance Professional, is an international training and consulting specialist with 25 years of experience. Mike is President/CEO of Premier Consulting Services Inc, PCSThis guide is the second Mike along with his co-author, Mark Waterfill on complying with the requirements of HIPAA Privacy and Security Rules. Mark Waterfill, Attorney-At-Lawspecializes his practice in business and employment law. Mark is a share holder and senior partner with DannPecarNewman & Kleimanlocated in Indianapolis IN. In addition to his law practice Mark is an international speaker and author on various topics related to both business & employment law.
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
"This book is for nurses, billing and insurance specialists, business associates, physicians and office managers. A resource for help understanding risk analysis, security implementation process, HIPAA and HITECH strategies"--Provided by publisher.
The escalation of security breaches involving personally identifiable information (PII) has contributed to the loss of millions of records over the past few years. Breaches involving PII are hazardous to both individuals and org. Individual harms may include identity theft, embarrassment, or blackmail. Organ. harms may include a loss of public trust, legal liability, or remediation costs. To protect the confidentiality of PII, org. should use a risk-based approach. This report provides guidelines for a risk-based approach to protecting the confidentiality of PII. The recommend. here are intended primarily for U.S. Fed. gov¿t. agencies and those who conduct business on behalf of the agencies, but other org. may find portions of the publication useful.
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Offering compelling practical and legal reasons why de-identification should be one of the main approaches to protecting patients' privacy, the Guide to the De-Identification of Personal Health Information outlines a proven, risk-based methodology for the de-identification of sensitive health information. It situates and contextualizes this risk-ba
Protecting Your Health Privacy empowers ordinary citizens with the legal and technological knowledge and know-how we need to protect ourselves and our families from prying corporate eyes, medical identity theft, ruinous revelations of socially stigmatizing diseases, and illegal punitive practices by insurers and employers. It's a new era in healthcare. Gone are the day when access to your medical records is limited to you and your doctor. Instead, today, a diverse group of constituencies have interest in and access to your health information. A cascade of changes in technology and the delivery of healthcare are increasing the vulnerability of your medical information. Accordingly, it is now more important than ever to take control over your own health information and take steps to protect your information against privacy breaches that can adversely impact the quality of your health care, your insurability, your employability, your relationships, and your reputation. In clear, non-technical language, privacy lawyer Jacqueline Klosek teaches readers the basics you need to know as an individual healthcare consumer about the ongoing wave of national and state legislation affecting patient privacy: the Patient Protection and Affordable Care Act (PPACA) of 2010, the Health Information Technology for Economic and Clinical Health Act (HITECH) of 2009, and the Health Insurance Portability and Accountability Act (HIPAA) of 1996. She untangles the increasingly complex ways by which health care providers, insurers, employers, social networking sites, and marketers routinely collect, use, and share our personal health information. Protecting Your Health Privacy: A Citizen's Guide to Safeguarding the Security of Your Medical Information empowers ordinary citizens with the knowledge and know-how we need to protect ourselves and our families from prying eyes, medical identity theft, ruinous revelations of socially stigmatizing diseases, and illegal punitive practices by insurers and employers.
(a) Design and construction. (1) Each facility or part of a facility constructed by, on behalf of, or for the use of a public entity shall be designed and constructed in such manner that the facility or part of the facility is readily accessible to and usable by individuals with disabilities, if the construction was commenced after January 26, 1992. (2) Exception for structural impracticability. (i) Full compliance with the requirements of this section is not required where a public entity can demonstrate that it is structurally impracticable to meet the requirements. Full compliance will be considered structurally impracticable only in those rare circumstances when the unique characteristics of terrain prevent the incorporation of accessibility features. (ii) If full compliance with this section would be structurally impracticable, compliance with this section is required to the extent that it is not structurally impracticable. In that case, any portion of the facility that can be made accessible shall be made accessible to the extent that it is not structurally impracticable. (iii) If providing accessibility in conformance with this section to individuals with certain disabilities (e.g., those who use wheelchairs) would be structurally impracticable, accessibility shall nonetheless be ensured to persons with other types of disabilities, (e.g., those who use crutches or who have sight, hearing, or mental impairments) in accordance with this section.
