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Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives

eClinical solutions are used to improve the clinical development process through data analysis and management. It offers clinical and operational data by providing data management software and customized data management services, including clinical reporting, electronic data capture, data management and standardization, and clinical data repository platform, with total transparency. eClinical solutions allow users to standardize, integrate, manage, and analyze all their clinical and operational data with the help of integrated advanced visualization and analytical capabilities. Moreover, eClinical software help users to comply with budgeting, investigator management, patient management, government regulations, and adverse event reporting system among others. eClinical solutions integrate electronic health records, eTechnologies, electronic consent forms, clinical data management systems, and electronic data capture. Moreover, they are helping researchers in lengthy clinical research processes through proper management. eClinical solutions have gathered substantial market proposition among pharmaceutical and biopharmaceutical companies for streamlining their clinical trials and insights discovery across various phases from I to IV. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/eclinical-solutions-help-reduce-human.html

Practical steps to compliance with HIPAA Computer Policy: That the HIPAA has a clear and stringent policy on computers is absolutely understandable, because computers constitute the very soul of HIPAA. Ensuring security of patient data is one of the core causes for which HIPAA was enacted; so, it is only natural that Computer Policy should be at the center of HIPAA compliance. A HIPAA Computer Policy rule came into effect in 2005. The nub of this enactment is to ensure that there are technical, physical and administrative security procedures that must be adhered with. These are meant for Covered Entities to ensure that the data they have of patients, namely electronic Protected Health Information (PHI) is safe and secure. Understand the reason for HIPAA Computer Policy Any implementation has to start with an understanding of the rationale for the action, right? The same goes for something as important and big as implementation of HIPAA compliance into systems. HIPAA Computer Policy is in place for a specific and critical reason ���protection of patient data, loss of which can lead to hefty penalties that can affect the business very adversely. So, installing the necessary protections is the first step to protecting vital data and with it, one's own business or practice, as well. Implement a sound access policy A strong access policy is at the heart of HIPAA Computer Policy. It is in the computer systems that all the data relating to the patient are stored. So, making sure who in the organization has access to these and how and when, is very important. Not only should access be restricted to only designated and permitted personnel in the organization; there should be a system by which tracking of access is easily determined. This is to find out who accessed which record, when, what action followed, what happened as a result of this access, and so on. Keep a record of all system components This is another step to ensuring compliance with HIPAA Computer Po

Understanding Medical Identity Theft and ways of preventing it Medical Identity Theft is a common phenomenon in today's situation, where most health records are digitized. Although a lot of precaution goes into the security and protection of these records, Medical Identity Theft is a cause for worry. medicalIdentityTheft The most common types of data that are stolen are Social Security Number (SSN), name and the Medicare number, the most potent tools with which to impersonate and manipulate data. Why do crooks steal medical data? Medical Identity Theft happens mainly because hackers and mischief-makers access protected data to lay hands on confidential information about patients, using which they obtain medical care on behalf of the person/s whose records they steal or purchase expensive medicines. In many cases, a Medical Identity Theft is detected only after one gets a bill for a purchase or service that was never made. medicalIdentityTheft Medical Identity Theft is also committed to buy drugs and obtain fake bills that are then submitted to Medicare in the name of the original holder of the medical record. These acts can significantly dent a person's credit rating. More importantly, when wrong information or fictitious diagnosis is made into the medical record, it can lead to dangerous consequences. Ways of protection of medical data The Office of the Inspector General (OIG), which comes under Health and Human Services (HHS), realizing the gravity of the problem of Medical Identity Theft, has formulated the "3D" approach to protect medical data and prevent Medical Identity Theft. These are: Deter: One of the ways of protecting medical data is to prevent Medical Identity Theft. Users should be cautious about parting with information to anyone who claims, over phone, to have a new scheme whose enrolment requires the Social Security Number. Detect:Many fraudsters accost people at accessible public places to announce supposedly "new" medical schemes. Governm

Overview: Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: * Understand US FDA final rules for the Preventive Controls for Human and Animal Foods * Define and review your current system to identify gaps in your preventive controls planning. * Be able to develop and implement a valid preventive control company food safety plan to close any gaps * Write and implement appropriate procedures. * Know your requirements for control over your supply chain * Be able to plan and implement HARPC * Be able to perform environmental monitoring * Know how cross contamination can impact your preventive control plan * Know the difference between validation and verification * Understand and be able to use statistical process controls basics * Be able to plan and implement a team approach to preventive controls * Be able to help your food importers to jump through FDA hoops * Develop a system to risk rank your suppliers * Have a plan in hand that will pass any validation check for preventive controls * Understand some of the technology and costs that can help you establish preventive controls * Prove that your system actually prevents food safety problems * Be able to document and report results to upper management, external food safety auditors and FDA auditors * Save your company money Establish simple, low cost complete data collection and reporting systems. * Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system * Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures * Learn how to use your system to get some ROI and improve your marketing position * Review current and future technologies designed to improve and simplify data collection * Establish a completely documented system Why should you attend: Validation of preventive co

HIPAA Breach Notification Rules and its new version : Let us begin at the beginning: What is breach notification? The term is pretty simple to understand. It means notifying the authorities whenever there is a breach of Protected Health Information (PHI). Covered Entities (CE's) and Business Associates (BA's), who are closely associated with PHI, and individuals whose PHI data are breached, are required to bring such data breaches to the notice of the authorities, whenever there is one. A breach notification is a mechanism that is aimed at ensuring that BA's and CE's meet requirements in the HITECH Act in the American Recovery and Reinvestment Act of 2009 (ARRA). To whom should the affected individuals and CE's and BA's complain? Whenever there is a breach of PHI by a CE or a BA, or if there is violation of the Privacy, Security, or Breach Notification Rules, the affected individual can complain to the Office for Civil Rights (OCR), which will initiate investigation into these complaints. Whenever a CE or a BA detects a breach, it can complain to the Secretary of Health and Human Services (HHS). In addition, the HIPAA breach notification rules have clear guidelines on how to report breaches in the following classifications: HIPAA's definition of a breach A breach of PHI is said to have taken place when any unpermitted use or disclosure that compromises the security of the data in the PHI takes place. Any such action, resulting in the breach of any kind of data contained in a PHI, big or small, is considered a breach, unless the CE or BA can explain that the data that got breached into was not serious enough, from its risk assessment point of view, to warrant immediate intervention. The new HIPAA breach notification rules The HHS embarked on a new HIPAA breach notification program, the HIPAA Privacy, Security, and Breach Notification Audit Program, with which it seeks to bring a few changes into the existing HIPAA breach notification rules. This new Audit Pr

The federal Health Insurance Portability and Accountability Act (HIPAA) was legislated in 1996 with the primary aim of ensuring that employees who are in the process of changing or leaving their jobs do not lose their health insurance benefits. Additionally, HIPAA sought to bring down health care fraud and abuse by mandating pan-industry standards for the protection of health care information and automated billing and other related processes, and for ensuring the security of Protected Health Information (PHI). What is a HIPAA Security Audit? A HIPAA Security Audit is a program under the HIPAA Privacy, Security, and Breach Notification Audit Program of the Office of Civil Rights (OCR). A HIPAA Security Audit is carried out to make sure that the policies, processes and controls on the part of Covered Entities comply with the provisions of the HITECH Act of 2009. Adherence to the requirements laid out by HITECH is mandatory. Given the high degree of continued use of new technologies that go into and will continue to go into electronic records of patients and the criticality of the data contained in them; the US Department of Health and Human Services (HHS) recognizes that there could be chances of data breach of Protected Health Information. It is to prevent the occurrence of these breaches that a HIPAA Security Audit is mandated by the HITECH Act. Reporting of data breaches is mandatory The foremost highlight of the HITECH Act is the requirement that Entities covered by HIPAA report data breaches that affect 500 or more employees to the HHS. The OCR lays out an Audit Protocol, with whose policies, protocols and processes a facility has to comply if it is said to be compliant with the HIPAA Security Audit. Why is it necessary to carry out a HIPAA/HITECH Security Audit? Compliance with HIPAA Security Audit is necessary to demonstrate that a practice or business is well protected. The most important reason for which such entities need to be HIPAA/HITECH Security

What is HIPAA ? Compliance with the Health Insurance Portability and Accountability Act (HIPAA) is a core requirement of the stakeholders involved in health information. HIPAA has prescribed standards with which to protect critical data relating to patients. Electronic Health Records (EHRs) are important documents that contain sensitive patient data, and are thus considered Protected Health Information (PHI). Since this data is accessible to a number of players involved in the field of healthcare; it extremely important to set regulatory guidelines aimed at ensuring that patient information remains protected. HIPAA compliance is essentially about staying in compliance with these guidelines. Measures needed to show compliance with HIPAA HIPAA requires a healthcare organization dealing with PHI to implement all of the following measures and comply with them: Physical measures Network measures, and Process security measures The role of HIPAA Privacy Rule and HIPAA Security Rule HIPAA has set out two important rules that pertain to compliance. These are the HIPAA Privacy Rule and the HIPAA Security Rule. While the Privacy Rule relates to how the medical information of a patient is saved, accessed and shared; the Security Rule is about how to implement national security safeguards for protecting electronic PHI, or ePHI. Who all need to be HIPAA compliant? Since the aim of HIPAA compliance is to ensure complete safety of patient data, it has requirements for every stakeholder in the EHR process. These stakeholders comprise: Covered Entities (CE): Anyone involved in the treatment, payment and operations in healthcare Business Associates (BA): Any person who has access to patient information and is involved in supporting treatment, payment or operations. These include third-party administrators and private sector vendors Those with whom BA's work, or those that are called subcontractors Hosting providers. These typically include healthcare software pro

Social media and healthcare: The advent of the social media into the healthcare industry has thrown open a hitherto unknown dynamic. It presents the industry the kind of opportunities that were hard to come by till now. Yet, it is full of challenges. It is now an inescapable fact and a given: the onslaught of the social media into the healthcare industry cannot be reversed. The wave is too strong to resist. The explosion in the use of social media has impacted the healthcare industry on a scale that is unprecedented. The universal pervasiveness of the social media Social media and healthcare have become great buddies mainly because of the sheer power of reach of the social media. What started out essentially as services that shared photos and messages has turned out to be a giant opportunity for the healthcare industry. Today, it is something that no one in the healthcare industry -or those outside it, such as the lay young population that seeks medical information - is insulated from. Now, not only patients, but also physicians and everyone of any significance in the healthcare industry use the social media to disseminate information. Social media and healthcare have become strongly paired also because they help in keeping the patient in close contact with the healthcare provider. It is no surprise that the social media have broken the barriers of age and geography in reaching out to the highest and widest range of users. Some trends about social media and healthcare: It is estimated that a fifth of the entire American population exchanged medical information over the social media in 2010 About three-fourths of all patients use the social media for some information before reaching a healthcare provider At least a thousand top US hospitals use social media for communicating with patients and providers Globally, up to half a billion people could be linking social media and healthcare by using the former Now, the challenges: Despite social media in t

Seminar on Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant at Boston, MA Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors. This seminar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant. Why should you attend? The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? Areas Covered in the Session: * Learn about the regulatory background and requirements for laboratory instrument qualification and system validation * Understand the logic and principles of instrument qualification and system validation from validation planning reporting * Understand and be able to explain your company's qualification and validation strategies * Be able to independently prepare execute test protocols, this includes s

With more than a 100,000 practitioners in this discipline; medical coding is catching up as a viable profession for many in the US and away. Medical coding is emerging as a completely specialized profession in the healthcare sector. This is how the core of their professional work needs to be understood: Uses of medical coding On the face of it, medical coding is used for filing healthcare claims, but the usefulness of this profession goes beyond this. The data churned out by medical coding helps healthcare professionals make more accurate diagnosis and help in enhanced treatment protocols. Ensuring accuracy in medical coding is crucial to administering proper healthcare. Medical coding not only ensures a systematic and standardized manner in which third parties claim payment; the critical data that medical coding generates can be harnessed for further use The information contained in medical coding data in the form of medical codes is a precise indicator of a patient's health history. This information, when refined, helps actuaries take decisions on making investments for their business By feeding policy makers and public health departments with important information on the incidence of diseases, medical coding also fosters proper allocation of resources to the particular segment of the healthcare industry about the kind of services that the community requires at a given point of time. This leads to an improved outlook for the general health of the patient population and reduces wastage of fund allocation. Learn more on this topic by visiting : http://bit.ly/23ajt0v

2-day In-person Seminar Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing Overview: The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary, from a risk management perspective Agenda Day One Lecture 1: Regulatory Requirements Lecture 2: Vocabulary and Concepts Lecture 3: Confidence Intervals (attribute and variables data) Lecture 4: Normality Tests and Normality Transformations Lecture 5: Statistical Process Control (with focus on XbarR charts) Lecture 6: Confidence/Reliability calculations for Proportions Lecture 7: Confidence/Reliability calculations for Normally distributed data (K-tables) Lecture 8: Process Capability Indices calculations(Cp, Cpk, Pp, Ppk) Day Two Lecture 1: Confidence/Reliability calculations using Reliability Plotting (e.g., for non-normal data and/or censored studies) Lecture 2: Confidence/Reliability calculations for MTTF and MTBF (this typically applies only to electronic equipment) Lecture 3: Statistical Significance: t-Tests and related "power" estimations Lecture 4: Statistical Significance: ANOVA calculations Lecture 5: Metrology (Gage R&R, Correlation, Linearity, Bias , and Uncertainty Budgets) Lecture 6: QC Sampling Plans (C=0 and Z1.4 attribute AQL plans, and alternatives to such plans) Lecture 7: Statistically valid statements for use in reports Lecture 8: Summary and Impleme

Overview: Essentially, covering in 90 minutes the basics of E everything that applies to your clinical work. We will give you the questions to ask your IT people, because you should not implicitly trust them, because the law will hold you accountable more than them. We will first cover the general principles of electronic compliances as laid forth in HIPAA. We will then discuss how this applies to your desktop/laptop/iPads and smart devices, other electronic equipment such as routers and modems. We also cover the use of email, secure mail and your EHR/EMR. We will discuss the pros and cons of using the cloud for your data storage and EHR/EMR, i.e. knowing what a HIPAA compliant data center looks like. Principles in the use of encryption and passwords and other security principles will also be covered. Why should you Attend: Unless you are 100% sure you've thought through every angle of your patient's electronic PHI and you sleep like a baby never concerned about this then you need to attend. If you have any questions about the details of what electronic compliance looks like and how it's applied in day-to-day clinical and business activities, interactions with vendors, EHR/EMR, your relationship with your ISP and IT providers, use of all electronic devices, then this workshop is for you. It also gives you principles to apply in new situations which are likely to arise frequently. If you wrote the book on this it would be out of date in 24 hours, so what's important is to learn how to think about these things and use your resources to stay ahead of the game. If you are confident you have the basics covered on every item listed below then this seminar is not for you. Areas Covered in the Session: HIPAA electronic compliance Secure use of EHR/EMR Email and secure mail use Encryption and password security principles Interfacing with the public Interfacing with vendors such as ISPs and other telecommunication companies Backups Cloud use How to know your data center

Outline Value Based Healthcare System - How it is seen today Healthcare Challenge & IoT as a Solution IoT - Big Data Structure Recent Trends in IoT Big Data Analytics Challenges & Our Future In-depth Knowledge of What causes the most premature death? Distribution of Disease burden from 1990 - 2020 Challenges in Healthcare Future Healthcare IoT Machine Talking to Machine Prediction of IoT Usage About PEPGRA HEALTHCARE, A leading healthcare communication firm with years of excellence serving clients with a dedicated team of Medical, Regulatory and Scientific writers specialized in all therapeutic areas. Contact us at : UK: +44-1143520021 US/Canada: +1-972-502-9262 India: +91-8754446690 info@pepgra.com www.pepgra.com

The major factors driving the healthcare interoperability solutions market are adoption of cloud technology related to healthcare services. Electronic health record data is increasing rapidly, and therefore, it is difficult to store the bulk data on the local storage devices, as there is chance of losing essential data.

Overview: The webinar will concentrate on topics that HHS has announced will be the focus of the first round of "desk audits". They reflect significant areas of non-compliance revealed in the 2012 pilot audits and HHS HIPAA violation investigations concluded by Resolution Agreements and Corrective Action Plans. They include: HIPAA Risk Analysis Risk Management based on Risk Analysis Breach Notification Notice of Privacy Practices (for Covered Entities) Minimum Necessary Standard Access of Individuals to their PHI Authorizations Workforce Training This webinar is vital because, in focusing on preparation for a HIPAA Compliance Audit, Covered Entities and Business Associates may review, prioritize and structure their HIPAA Compliance programs. If you have HIPAA Compliance documentation ready to submit on two weeks notice to HHS you are implementing an effective HIPAA Compliance program. In addition, every Covered Entity or Business Associate may face an HHS HIPAA Compliance investigation at any time due to a complaint or a Breach. If you are "audit ready" you will be ready for an investigation - and better able to avoid complaints and prevent breaches. Why should you attend: Every Covered Entity and Business Associate is liable - without prior notice - to be audited for HIPAA Compliance by HHS You will have only 2 weeks after receiving your HIPAA Compliance Audit notification and data request to upload all requested documents to an HHS HIPAA Compliance Audit Portal The HIPAA Compliance Audit data request you receive will specify content and file organization, file names and any other document submission requirements Auditors will not contact an audited entity for clarifications or ask for additional information - it is essential that submitted documents are current, accurately reflect the entity's HIPAA Compliance program and demonstrate HIPAA Compliance Only data submitted on time will be assessed Failure to respond on time may be referred to the HHS regional

Sharing of behavioral health patient data has been a conflicting issue since the healthcare technology reforms started in the country. Under these reforms

It is about accuracy of data for each performance category that matters the most in MIPS. As a MIPS Qualified Registry for the fourth time in a row is a living proof of our past performances and current status. In this article, we got a chance to reflect on a few MIPS data essentials; and thought they would be useful for clinicians before the submission window closes for good.

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

Overview: Section 13411 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, requires Health and Human Services (HHS) to conduct periodic audits of providers and business associates to ensure their compliance with the HIPAA Security and Privacy Rule, and breach notification standards. To implement this mandate, the Office of Civil Rights (OCR) has conducted HIPAA/HITECH audit program with KPMG of 115 health care organizations to assess privacy and security compliance. This webinar will focus on the implementation and tracking of HIPAA audit best practices in a healthcare setup in order to prepare for the federal audit using published OCR audit protocols. Every audit begins with interviews, a questionnaire, and a thorough policy and procedures review. Presenter, with his decades of knowledge in the compliance, legal, auditing and security areas, will walk the attendees through the audit process, documentation requirements, and implementation specifications of the HIPAA privacy, security and breach rules. This presentation not only provides opportunity for the participants to prepare for the federal HIPAA audit but also to improve the security posture of their organizations by adopting to changing technology (mobile, social media, Health Information Exchange(HIE), cloud services, etc.) and threat landscape perspective as well. This presentation will uncover reasons why many health information breaches are occurring and help organizations better secure and comply with electronic protected health information by meeting the required and addressable HIPAA/HITECH security rules. The presenter will also share the best practices used for HIPAA security implementation and continuous risk assessment which is considered as "due diligence" by auditors for the HIPAA security compliance program. Areas Covered in the Session: Healthcare Technology Adoption/Trends Healthcare Regulatory (HIPAA/HITECH) and OCR/HHS Audit Overview Differences between