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Key#1: Understand the regulations that pertain to your industry and your business throughout each level and function of your organization This is more difficult than it appears because Federal Regulations are simply not prescriptive and that is by design. 21CFR 820 Medical Device QSR for example, must be applicable to both manufacturers of small surgical instruments as well as manufacturers of MRI devices requiring that the regulations be sufficiently vague and flexible to pertain to each product. At the end of the day, it is the responsibility of every regulated organization to interpret those governing regulations as they pertain to the company's unique product and processes and apply those interpretations throughout the organization. In most cases, this will require the assistance of outside industry and regulatory experts to make these interpretations and the case for the direction that the company chooses to go. Certainly the most simplistic solution to achieving compliance excellence is "to do the right things right!" But what does this really mean? I have distilled the "doing the right things right" solution into 7 separate individual keys or actions that will provide a solid foundation for the establishment of any compliance program. Key#2: Define your critical processes relative to the regulatory path that has been chosen. Many organizations do not adequately define their processes After choosing a regulatory path, complete and thorough process definitions that are foundational to the business must be developed and validated with linkage to the governing regulations. These process definitions are the first rung on the ladder, the "50,000 ft. view," the genesis of the operational and regulatory paradigms that will form the structure of how the business will be run in an efficient, effective, and compliant manner. Key#3: Develop sound regulatory documentation Documentation should not simply meet a regulatory requirement but be designed to effectively direct operations, be foundational to a comprehensive worker training approach, and serve as the basis for a sound continuous improvement process. Key#4: Harmonize your processes and procedures between plants Inconsistency between operations although not necessarily a problem are cause for concern when those inconsistencies are uncovered during an inspection or investigation. Best practices should be determined for "like" operations, equipment, processes, etc. and then implemented across all facilities and locations where those "like" operations exist. Key#5: Commit to and execute comprehensive technical training. Competence is the prerequisite to competition and compliance "Read and Understand" the most basic of approaches used to transfer "knowledge and skill" in the life sciences today simply does not work. If your goal is to just meet a regulatory requirement, this is as far as you need to go - buy an LMS, build the most basic of technical documentation, assign document readings, roll the regulatory inspection dice, and you are good to go. If your goal, on the other hand, is to create an organization that meets or exceeds your regulatory responsibilities, demonstrates operational excellence, develops and deploys superior competence, and truly demonstrates the attributes of a learning organization, you must invest in training infrastructure, organizationally support training, provide training a seat at the operations and regulatory tables and include the function in the decision-making and advisory processes, and consistently execute an effective training process for both new and existing human resources. Key#6: Institute a sound and effective complaint and investigations handling process : Looking at a history of 483 observations and warning letters will tell you that CAPA deficiencies uncovered during FDA investigations consistently rank in the top three of the reasons for triggering a 483 warning letter. It is essential that CAPA systems and processes be fully integrated with corporate strategies and policies and there be a commitment up and down the organizational structure to fully execute the process. Key#7: Manage performance up and down the line to the performance structure created. If it is not managed it will not be performed Junior level managers and supervisors and the workforce in-general for that matter, must never be given cause to think that circumventing or ignoring a process or a step to a procedure is acceptable behavior even if it impacts throughput, schedules, or the "bottom-line." The risks to patient and end-user health and safety are simply too great. Regulatory compliance must be sacrosanct and an enforceable component of the performance management system. That message must be sent and received throughout the organization. The intent of this approach is to demonstrate linkage between each level beginning with the regulatory requirements themselves through regulatory documentation, through the training process, ending ultimately with the management of individual human performance.....https://www.complyarena.com/articledetails/39

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What is Human Factors and Usability Validation? FDA uses human factor and usability validation guidance document to assist studies how people interact with systems. Medical device manufacturer, pharmaceutical concern producing a drug delivery system such as an injector or inhaler, follow appropriate human factors and usability engineering processes. Human factor studies play an integral role in your concern to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments. Human factors or usability engineering processes are to be followed during the development of new medical devices, focusing specifically on the user interface, where the user interface includes all points of interaction between the product and the user(s) including elements such as displays, controls, packaging, product labels, instructions for use, etc. FDA continues to focus on the importance of conducting human factors studies for medical devices prior to premarket submissions. Its Importance The influx of recent FDA discussions and robust guidance documents are on the heels of several reports of life-threatening device user errors. Human Factors studies provide validity and value to medical device regulatory submissions. Human factors / usability validation is very different from device validation, Click here to learn more in this session. These human factor studies encourage manufacturers to: Improve the safety of medical devices and equipment to reduce user error Improve the design of medical devices to minimize potential use errors Help careful design of the user interface, the hardware and software features that define the interaction between users and equipment Better evaluate safety, effectiveness, and substantial equivalence of medical devices To save time, money, and resources in the long-run by application of these validation procedures from the start Understand the feedback from human factor tests and design easier-to-use devices Design and develop safer connections between device components and accessories (e.g., power cords, leads, tubing, cartridges) Help ensure reduce user reliance on user manuals, and user training and retraining Application of Human Factors and Usability Validation Tests FDA has recommended that medical device manufacturers and clinical researchers design human factor and usability validation studies, should almost "test drive" their products in real-life circumstances, requiring closer interaction with patients and consideration of their feedback. Human factor and usability validation studies may seem complicated, but it could be summarized as below: Ensure you evaluate and include the below while designing a study Start by obtaining a copy of the standard. You can buy the standard from ISO Differentiate between the "Customers" and "Intended Users", Click here to learn more in this session. Interviewing intended users Direct observation of the device of interest Perform failure mode and effects analysis (FMEA) - detailed task analysis of everything a user can do Apply a set of usability heuristics to a design, identify violations, and assess the severity of each violation Deploy the appropriate analytical approaches to early-stage design Review test results received after a few users and stop testing if significant changes are needed. Fix and reiterate Perform formative user studies for each new prototype Evaluate labels and comprehension of instructions for use (IFU) You may need to extend your Usability Engineering Process to include non-electrical devices and interfaces Ensure your in-house usability team is familiar with the changing FDA requirements Summary : In the USA, the Food and Drug Administration (FDA) has recognized ISO/IEC 62366 and has issued a list describing the minimum documentation that must accompany any declaration of conformance to the standard. Incorporating human factors early and often throughout the design can result in a better, safer, and more usable design. Early incorporation ensures that you can avoid making changes to designs late in the development process and, in worst cases, the high costs associated with device recalls. Ensure your in-house usability team is familiar with the requirements in the standard and draw up a plan for Human factor and usability validation Process in place. You can also find an experienced usability consultant who can help you understand the details of the standard and can work with you to implement the requirements. Always keep your in-house team updated with the latest from FDA.......https://www.complyarena.com/articledetails/Introduction-To-Human-Factors-and-Usability-Validation-Tests

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The Centre for Veterinary Medicine is one of the smallest centers within the Food and Drug Administration. It's a very diverse entity where animal health as well as public health gets addressed. It's staffed with a range of professionals from scientists who are experts in veterinary medicine, molecular biology, risk assessment, animal physiology and food safety. FDA CBM approves any drug given to any sick animal, it includes food producing animals, pet animals like dogs, cat, horses including ornamental fish. Main tasks of the Centre for Veterinary Medicines are: Evaluate animal drugs to make sure that they are safe and effective prior to entering the market place Ensuring that animal drugs are safe for humans who might consume food derived from those animals for the animals themselves for the environment Ensure that the drug is effective for its intended purposes Evaluation of Products: The process involves working with the pharmaceutical sponsor to develop what requirements will be necessary to demonstrate that a product is safe and effective Working on the technical sections of the medicine to make sure that each of the components are safe & effective for the target animal Also working on the safety and effectiveness of the manufacturing chemicals and its effect on the environment Ensuring the human food safety of the medicines which composes of toxicology residue chemistry and microbial safety Steps through applying to approval of a trail drug: For a sponsor to get approval of a trail drug, the application goes through the below steps in rounds till it is approved or till successful. There will be an initial engagement stage - It's generally a pre-submission conference in which the sponsor will educate the center on the various characteristics and aspects of their particular drug product through a dialogue Next step is for extra information query The center comes back with the additional requirements for the study The extra information and questions that they need from the supplier Also they can suggest a few steps that would help successfully demonstrate that the product is safe and effective for approval Result communication from the approval Centre The result is generally communicated through different ways It includes the conditions of use of the medicine The label for the drug, i.e., information to the end user of how to properly use the drug and the conditions under which it will be safe and effective Publishing freedom of information summary - The approval Center outlines the particular studies and information that was looked at and the conclusions drawn through the process of evaluation Updating online and ensuring availability of the result on a searchable database on in FDA CBM website Farmers and animal owners need to have remedies to relieve suffering and death in their animals and hence importance of safe & effective labeling of drugs is stressed Problems faced during approval of Veterinary Drugs: Rule requires that a covered entity or a business associate will provide notice of a breach to a covered entity. The medicine has to ensure that the animals and public health is protected at all times Approver should be knowledgeable about a huge variety of animals, it's challenging job to figure out what to use in a 1500 pound horse or a 2000 pound cow or an iguana Distinguishing between major and minor species and how disturbing one of them will destroy the ecosystem, like importance of bees in the pollination of crops Strains faced by one department to approve medicines for all the different animals, even when the animal treated might not be important commercially or might be a really small animal Extended periods of marketing exclusivity given to company ones it gets a product approved, protection for a product from competition for up to seven years Approving the dosage and labeling for animal pharmacy is extensively intense and time consuming Approval needs to keep the whole world of animals in the picture, not just the local ones around There are 3 different sections that need continuous monitoring, animal feeds, animal drugs and compliance of food and safety Continuous monitoring of approved drug on all breeds in a species to ensure either food labeling change or disapproval of the medicine. Example dogs have a product approved, based on tests on boxers and spaniels and when the drug is out pugs don't react as well and changes in drug level is done based on animal weight Continuous lookout for antimicrobial resistance in animals. When an animal is infected by resistant bacteria the treating veterinarian turns to more expensive or even more toxic antimicrobials to try to clear the infection Continuous monitoring of the dangers of drugs to animal intended for the food supply as bacteria/resistant bacteria can be transmitted through the food supply and cause disease in humans Constant surveillance of resistance to drugs by animals intended for human consumption, taking intervention to try to limit/contain resistance, monitoring and estimating how big an impact an intervention had and whether it really had the intended consequences Compliance department has to workup all types of compliance actions. The USDA inspects all animals that come through slaughter plants and a number of different sampling strategies are taken and tested to ensure that animal drugs monitored are approved ones and are in levels that are above accepted tolerance levels Sending inspectors to the actual farm and testing animals when drug is found in a higher quantity than approved, and taking appropriate action when and if so Ensuring different levels of follow up is undertaken when an issue is found, starting from verbal, followed up with an official warning letter moving to seizure or an injunction and as a last step they will be liable to prosecution Ensuring and constantly checking the quality of meat imported into the country from other places where the checks might not be so stringent Constant international collaboration to regulate and for an acceptable standard of chemicals introduced into animal drugs and their feed Keeping up-to-date with the genetically modified animals and their effect on humans during consumption

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This post isn't a conclusive listing of what's required for HIPAA compliance and is designed to point you in the best direction. You should assign a Privacy Officer to examine each rule in its entirety. HIPAA compliance 2018 rule "requires appropriate administrative, physical and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information" The majorities of us believe that our medical and different wellness data is individual and should be secured. We also believe we should know who has this information and worry about how safe it is. The Privacy Rule, a Federal law, provides you with rights around your quality of life data and models principles and limits on who can look at and obtain your Health information. As long as we ensure reasonable safeguards, 2018 changes to HIPAA compliance Privacy Rule and Security Rule allow appropriate electronically communication and handling of health care 'Protected Health Information'. All personal medical information, including name, address, Social Security number, and all medical information about an "individual" come under PHI. HIPAA 2018 Changes In this HIPAA session we will be discussing HIPAA 2018 Changes taking place in Washington with the Health and Human Services when it comes to the enforcement of the HIPAA regulations already on the books as well as some step-by-step discussions on the audit method and some current functions regarding HIPAA cases (both in courtrooms and from live audits). Attend this Session As a healthcare organization, you must still make sure that a few checks and steps are taken to ensure that HIPAA compliance 2018 changes are followed within the organization: Administrative Safeguards: Always have a documented physical security policies and procedures. Helps guide existing and new security personnel Have designated HIPAA compliance officers whenever and wherever possible Injunction instructions should be documented and followed against workforce members who fail to comply with the security policy Continuous security upgrading and reminders in the form of seminars, test and webinars conducted internally Appling procedures to documents information system activities, such as audit records, access reports and security-incident checking reports Ensure regular reviews of the audit trails, logs and system activity of the employees with access to ePHI Planning and timed reviewing of procedural contingency policy on accessing backups of ePHI, establishing continuous processing of critical business process for protection of ePHI Special business partners compliance contracts with partners who will have access to ePHI. Choose partners that have similar agreements with any of their partners to which they are also extending access HIPAA - Texting & Emailing in 2018 With the introduction of smartphones, emails have become the even more accessible form of communication. In conjunction with email comes the issue of security and them being intercepted and read by unintended persons. Precautions and steps are to be taken at every step of the way. So for a Healthcare concern or a business associate, it's a key to maximize patient communication tools while protecting itself and the organization from government penalties and patient lawsuits. Attend this Session Physical Safeguards: Identifying and assigning personnel for developing and implementing security policies and procedures Disaster recovery plan and emergency plan, which is away from the normal operation facility. This ensures that the organization has a data backup plan established to create, maintain retrievable and restore exact copies of ePHI Employee workstation access and security - ensure proper password control, applications accessed and installed, and the physical attributes and the surroundings of the workstation that can access ePHI Following proper procedures for proper disposal of old/used hardware, proper reuse of the same All old hardware disposed should have data backed up from those disposed hardware Any paper trail of ePHI data is only accessible to selected employee and are always secured properly Implementing strong Bring-Your-Own-Device [BYOD] HIPAA Compliance policies in the organization where ePHI data is accessible and technology tools are integral to control the access to data outside the organization HIPAA Privacy Officer: Module 1 HIPAA Privacy Officer Training will uncover all HIPAA and HITECH expectations in protecting patient and member's right to privacy and the confidentiality of Protected Health Information (PHI) as you engage in treatment, payment, and healthcare operations (TPO) services. Attend this Session Technical Safeguards: Steps for creating changing and securing password management should be documented and implemented regularly Security measures to ensure integrity of the ePHI data that electronically transmitted - making sure they are not improperly modified without detection until discarded Securing digital ePHI data by encrypting them, at all/most times, by whenever means deemed appropriate Securing access control points by ensuring critical thought process is put into password protection, rules for accessing data, automatic log off from systems Audit controls implementing hardware, software and procedural restriction and procedures to record activities on information system that have healthcare data Under new HIPAA 2018 Compliance rule ensure proper steps to be taken by the organization when a patient has not agreed to receive ePHI in unencrypted email or unencrypted text message Ensure ePHI data that are at rest i.e. data that is kept in databases, servers, flash drives either by password protection or access to physical hardware is restricted and data is all/most time's encryption For all online forms that use or request or accept ePHI ensure the use of security measures, such as SSL and advanced password protections like 2FA In 2018 HIPAA Compliance Privacy rule make sure that anti-virus softwares are run and systematically updated on machines that have access to ePHI Current recommendation of using NIST-recommended AES 256-bit encryption standard for data transmissions through electronic devices HIPAA Privacy Officer: Module 2 HIPAA Privacy Officer Training will cover all ongoing activities of a Privacy Program related to the development, implementation, maintenance of, and adherence to the organization's policies and procedures covering the privacy of, and access to, patient health information in compliance with federal and state laws and the healthcare organization's information privacy practices. Attend this Session Critical steps for the success in passing HIPAA Compliance checklists for 2018 Reviewing all the above steps and procedures periodically Documenting procedures and changes done to anything related to ePHI Under HIPAA 2018 Compliance rule ensure your employees are up to date at all times with regards to the procedures Ensuring the end user know about your organization handling of ePHI Determine the likelihood of threat occurrence with ratings such as high, medium and low or numerical represent probability of threat......https://www.complyarena.com/articledetails/Critical-2018-HIPAA-Compliance-Updates-Trump-Administration

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The Privacy Rule issued by U.S. Department of Health and Human Services ("HHS") Goal - strikes a balance between protecting individuals' health information and allowing/permiting the flow of health information needed to provide quality health care. Regulates - address the use and disclosure of individuals' health information - called "protected health information" by organizations subject to the Privacy Rule called "covered entities," as well as standards for individuals' privacy rights to understand and control how their health information is used. The HIPAA Rules provide federal protections for patient health information held by Covered Entities (CEs) and Business Associates (BAs). The HIPAA Privacy Rule covers protected health information in any medium while the HIPAA Security Rule covers electronic protected health information. Personal health information or protected health information (PHI) Refers to demographic information, medical history, test and laboratory results, insurance information and other data that a healthcare professional collects to identify an individual and determine appropriate care. Requirements of PHI Any health information information, whether oral or recorded in any form or medium Is created or received by a health care provider, health plan, employer, or health care clearinghouse Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual or the past, present, or future payment for the provision of health care to an individual: That identifies the individual; or With respect to which there is a reasonable basis to believe the information can be used to identify the individual HIPAA - Ignorance of the law is NO defence for being out of compliance The HIPAA Privacy Rule and Security Rule set national standards requiring organizations and individuals to implement certain administrative, physical, and technical safeguards to maintain the confidentiality, integrity, and availability of protected health information (PHI). HIPAA violations Four categories of violations that reflect increasing levels of culpability Four corresponding tiers of penalties that significantly increase the minimum penalty amount for each violation A maximum penalty amount of $1.5 million for all violations of an identical provision Penalties for HIPAA violations Applies to both covered entities and individuals Determined by the Office for Civil Rights and by state Attorney Generals is generally not be exclusively financial can result in civil and criminal penalties progressive disciplinary actions can include termination covered entities include healthcare providers, health plans, healthcare clearinghouses and all other CEs - including Business Associates (BAs) of CEs HIPAA Security Rule - Need for HIPAA Security Rule Ensuring implementation of appropriate security safeguards and protective measures for electronic health care information that may be at risk Protecting an individual's health information, while permitting the appropriate access and use of that information, promoting the use of electronic health information in the industry The Security Rule applies only to electronic protected health information (ePHI), ensuring the data's. Confidentiality - EPHI is accessible only by authorized people and processes Integrity - EPHI is not altered or destroyed in an unauthorized manner Availability - EPHI can be accessed as needed by an authorized person Who needs to comply with Security Rule? HIPAA - covered entities and and business associates of covered entities who electronically transmit any health information in connection with transactions for which HHS has adopted standards. HIPAA - covered entities are: Covered Health Care Providers - Any provider of medical or other health care services or supplies who transmits any health information in electronic form Health care clearinghouses - A public or private entity, that process health information from nonstandard data format into standard data elements or vice-versa. Includes billing service, repricing company, community health management information system or community health information system Health care providers - A provider of medical or health services and any other person or organization who furnishes, bills, or is paid for health care What makes up Security Rule? There are 3 parts of the Security Rule that covered entities must know about: Physical safeguards - includes mechanisms required to protect electronic systems, equipment and the data they hold, from threats, environmental hazards and unauthorized intrusion. They include restricting access to EPHI and retaining off site computer backups Technical safeguards - the automated processes used to protect data and control access to data. They include using authentication controls to verify that the person signing onto a computer is authorized to access that EPHI, or encrypting and decrypting data as it is being stored and/or transmitted Administrative safeguards - includes items such assignment or delegation of security responsibility to an individual and security training requirements.....https://www.complyarena.com/articledetails/40

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Risk analysis and risk management are the foundation of a covered entity's Security Rule compliance efforts. Conducting a risk analysis is the first step in identifying and implementing safeguards that comply with and carry out the standards and implementation specifications in the Security Rule. HIPAA 2018 Changes In this HIPAA session we will be discussing HIPAA 2018 Changes taking place in Washington with the Health and Human Services when it comes to the enforcement of the HIPAA regulations already on the books as well as some step-by-step discussions on the audit method and some current functions regarding HIPAA cases (both in courtrooms and from live audits). Attend this Session HIPAA security Rule - RISK ANALYSIS AND RISK MANAGEMENT REQUIREMENTS Risk analysis and risk management are ongoing processes that will provide the covered entity with a detailed understanding of the risks to EPHI and the security measures needed to effectively manage those risks. The Rule indicates that risk analysis is a necessary tool in reaching substantial compliance with many other standards and implementation specifications. Performing these processes appropriately will ensure the confidentiality, availability and integrity of EPHI, protect against any reasonably anticipated threats or hazards to the security or integrity of EPHI, and protect against any reasonably anticipated uses or disclosures of EPHI that are not permitted or required under the HIPAA Privacy Rule. HIPAA - Texting & Emailing in 2018 With the introduction of smartphones, emails have become the even more accessible form of communication. In conjunction with email comes the issue of security and them being intercepted and read by unintended persons. Precautions and steps are to be taken at every step of the way. So for a Healthcare concern or a business associate, it's a key to maximize patient communication tools while protecting itself and the organization from government penalties and patient lawsuits. Attend this Session What are the Risk Analysis and Risk Management Requirements? The Security Rule requires covered entities to evaluate risks and vulnerabilities in their environments and to implement policies and procedures to address those risks and vulnerabilities. Risk Analysis, requires a covered entity to, "Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity" Risk Management, requires a covered entity to "Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level" HIPAA Privacy Officer: Module 1 HIPAA Privacy Officer Training will uncover all HIPAA and HITECH expectations in protecting patient and member's right to privacy and the confidentiality of Protected Health Information (PHI) as you engage in treatment, payment, and healthcare operations (TPO) services. Attend this Session Risk Analysis should be done to ensure that data are not be: Accessed without authorization, (malicious or accidental) disclosure, modification, or destruction of information Unintentional errors and omissions IT disruptions due to natural or man-made disasters Failure to exercise due care and diligence in the implementation and operation of the IT system HIPAA Privacy Officer: Module 2 HIPAA Privacy Officer Training will cover all ongoing activities of a Privacy Program related to the development, implementation, maintenance of, and adherence to the organization's policies and procedures covering the privacy of, and access to, patient health information in compliance with federal and state laws and the healthcare organization's information privacy practices. Attend this Session HIPAA Security Rule RISK ANALYSIS STEPS: Identify all e - PHI within HTE organization, both going out coming in Establish the scope of the risk analysis Gather all interconnected / corresponding data Recognize and diagnose potential threats and vulnerabilities Document threats and vulnerabilities using appropriate language and citations Assess current security measures Determine the likelihood of threat occurrence with ratings such as high, medium and low or numerical represent probability of threat Determine the potential impact of threat occurrence on EPHI data Determine the level of risk based on the likelihood of the threat and impact levels of the same Catalog the security measures Implement documentation of the measure using appropriate language and citations Periodic Review and Updates to the Risk Assessment.....https://www.complyarena.com/articledetails/41

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The HIPAA Survival Guide was developed as a collaborative effort between an attorney and a registered nurse, both licensed in the State of Florida. In addition the authors, both individually and collectively, have significant technology experience. However, neither author had significant HIPAA experience prior to this effort, although both had compliance experience in other industries. For personal and professional reasons, the need arose to acquire a much deeper understanding of HIPAA, especially in light of the recent nationwide initiatives of the administration regarding electronic health records. HIPAA 2018 Changes: In this HIPAA session we will be discussing HIPAA 2018 Changes taking place in Washington with the Health and Human Services when it comes to the enforcement of the HIPAA regulations already on the books as well as some step-by-step discussions on the audit method and some current functions regarding HIPAA cases (both in courtrooms and from live audits). Attend this Session Items in your Checklist Folders Documenting everything in the company from the company privacy, security and breach policies Reviewing training, rule, procedures used, documentation & updating them from time to time Having and implementing a foolproof risk mitigation plan Having a budget in the company allocated to ensure HIPAA compliance Performing an internal audit, at regular intervals of security risk analysis to find any vulnerability Creating and updating an action plan to address any security risk analysis Documenting all actions, correspondences and agreements with the patient or Business Associates at company and the involved personnel level Training employees on the steps, recording the same against employee and training on how to implement HIPAA compliance requirements on protecting PHI and ePHI Updating the provider's risk analysis or risk management plans if the same has not been done for two years or more Partial Privacy rule checklist that your auditor would bring in: Policy and procedure statement Steps on how to follow the policy and procedure Tracking your practice mechanism Keeping documentation of past history HIPAA - Texting & Emailing in 2018: With the introduction of smartphones, emails have become the even more accessible form of communication. In conjunction with email comes the issue of security and them being intercepted and read by unintended persons. Precautions and steps are to be taken at every step of the way. So for a Healthcare concern or a business associate, it's a key to maximize patient communication tools while protecting itself and the organization from government penalties and patient lawsuits. Attend this Session Violation of the rule and its consequences: Proving if they have violated will mean they go through the steps used to follow and implement the rule backward and showing its loop holes Sanction and training issue which is not tracked for future purpose or training of procedures do not reach employees Breach notification is when we have found out that a procedure is violated by going step by step into how it was implemented Any unsecured PHI leaving the company should be authorized else it’s a breach under most situations Defending and settling a law suit is real heavy - like 100k defend the case, fine for breach and 500k for settlement HIPAA Privacy Officer: Module 1: HIPAA Privacy Officer Training will uncover all HIPAA and HITECH expectations in protecting patient and member's right to privacy and the confidentiality of Protected Health Information (PHI) as you engage in treatment, payment, and healthcare operations (TPO) services. Attend this Session Incident management in HIPAA basically has these thought process involved: How do we investigate if the issue/incident is a violation? How are we handling the incident? How are we tracking issue on a continuous basis? How are you resolving the incidents? How are we recording the issue? How do we contact the person/employee involved? Who is carrying on the investment, the incident manager? Invoking methodology for determining if the incident has happened - it could be a rule violation or requires a breach notification Plan how to handles sanction against an employee who violates the rules Store violations/breaches data in a specified compliance repository folder at all times Any sanctions against an employee should be stored against him/his personal file HIPAA Privacy Officer Module: 2 : HIPAA Privacy Officer Training will cover all ongoing activities of a Privacy Program related to the development, implementation, maintenance of, and adherence to the organization's policies and procedures covering the privacy of, and access to, patient health information in compliance with federal and state laws and the healthcare organization's information privacy practices. Attend this Session Authorization of PHI access: Have a global process for how the authorization is handled From tracking when it's applied Who made the request? Who took the application? Who signed the authorization? How the authorization is handled? How is the patient communicated? Process should be in place and documented as to how authorizations are done per access Document when authorizations are mandated by HIPAA rule for using PHI data Ensure you always match the authorization in house with the actual HIPAA privacy rules Train staff when authorization is needed and keep track of the training in their personal file Always revisit your rule and match them to HIPAA rule and train guys Documents not reviewed regularly are willful neglect and can by itself mean a breach Always track who has access and authorization in a public repository at company level Patient file should have the request for data tracked and recorded in their personal files Self-audit at random times about how we can track authorization for PHI......https://www.complyarena.com/articledetails/HIPAA-Survival-Guide

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The HIPAA Breach Notification Rule, 45 CFR §§ 164.400-414, requires HIPAA covered entities and their business associates to provide notification to patients and the Department of Health and Human Services (HHS), following a breach of unsecured protected health information. Your ePHI data is deemed UNSECURED when The data is not declared useless, unreadable, or indecipherable to follow up by unauthorized persons, either as is or where deciphered using some sort of technological know-how or methods [specified by HIPAA authorities] HIPAA 2018 Changes In this HIPAA session we will be discussing HIPAA 2018 Changes taking place in Washington with the Health and Human Services when it comes to the enforcement of the HIPAA regulations already on the books as well as some step-by-step discussions on the audit method and some current functions regarding HIPAA cases (both in courtrooms and from live audits). Attend this Session Breach of ePHI Data excludes: Any unintentional acquisition: Any unintentional acquisition, access, or use of protected health information by authorized employee or a representative of a covered entity or a business associate. This is when the data accessed or used was made in good faith and within the scope of authority Any inadvertent disclosure: Any inadvertent disclosure by authorized employee or a representative of a covered entity or a business associate to another authorized employee or a representative of a covered entity or a business associate where the data is not used outside such disclosure Any disclosure: Any disclosure by authorized employee or a representative of a covered entity or a business associate to an unauthorized person when the authorized personnel has reasonable good belief perception that this not authorized person won't realistically have gotten to help hold on to such information. - Like a guardian, relative of the person HIPAA - Texting & Emailing in 2018 With the introduction of smartphones, emails have become the even more accessible form of communication. In conjunction with email comes the issue of security and them being intercepted and read by unintended persons. Precautions and steps are to be taken at every step of the way. So for a Healthcare concern or a business associate, it's a key to maximize patient communication tools while protecting itself and the organization from government penalties and patient lawsuits. Attend this Session Notification of Breach Notification Rule: A representative of a covered entity or a business associate shall, following discovery of a breach of unsecured protected health information, notify the covered entity of such breach. Determining a Breach: An acquisition, access, use, or disclosure of protected health information is presumed to be a breach. Exemption to this clause is when the covered entity or business associate demonstrates that there is a low probability that the PHI has been compromised. The below is the risk assessment factors/clauses used to demonstrate low probability: The nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification The unauthorized person who used the PHI or to whom the disclosure was made PHI need to be actually acquired or viewed by unauthorized personnel The extent to which the risk to the PHI has been migrated Breach discovered: A breach shall be treated as discovered by a covered entity or a business associate. As of the first day on which such breach is known to them OR By exercising reasonable diligence, would have been known to them HIPAA Privacy Officer: Module 1 HIPAA Privacy Officer Training will uncover all HIPAA and HITECH expectations in protecting patient and member's right to privacy and the confidentiality of Protected Health Information (PHI) as you engage in treatment, payment, and healthcare operations (TPO) services. Attend this Session Notification within: Rule requires that a covered entity or a business associate will provide notice of a breach to a covered entity. Without unreasonable delay AND In no case later than 60 days following the discovery of a breach In case the business associate is not an agent of the covered entity, then the covered entity is required to provide notification based on the time the business associate notifies the covered entity of the breach Training for HIPAA Compliance Training of workforce: It's the responsibility of the covered entity or the business associate in: Ensuring that all workforce members are appropriately trained and knowledgeable about what constitutes a breach Updating the policies and procedures for reporting breach Ensuring proper steps for analyzing are documented and staff trained for the same Documenting all policies, procedures for analyzing and reporting possible breach of unsecured protected health information Burden of proof rests on covered entity or business associate and hence ensuring all notifications should be recorded HIPAA Privacy Officer: Module 2 HIPAA Privacy Officer Training will cover all ongoing activities of a Privacy Program related to the development, implementation, maintenance of, and adherence to the organization's policies and procedures covering the privacy of, and access to, patient health information in compliance with federal and state laws and the healthcare organization's information privacy practices. Attend this Session Content of Breach Notification A breach notification shall be written in plain language. A breach notification shall include the following elements: A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known A description of the types of unsecured protected health information that were involved in the breach (such as whether full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved) Steps individuals should take to protect themselves from potential harm resulting from the breach A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to individuals, and to protect against any further breaches and Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an e-mail address, Web site, or postal address.....https://www.complyarena.com/articledetails/New-2018-HIPAA-Breach-Notification-Rule-Update

texting-and-e-mail-with-patients-patient-requests-and-complying-with-hipaa icon texting-and-e-mail-with-patients-patient-requests-and-complying-with-hipaa

In the past few years, opportunities to communicate electronically have increased significantly and electronic communication (e-communication) is no longer limited to e-mail on the desktop. The advent of web enabled (or smart) phones and pad computers makes it possible to access information and send and receive messages anywhere there is a cell signal or wireless network. Mobile communication technologies have spread with remarkable speed. By the end of 2011, more than 5.6 billion people worldwide were using cell phones and smart phone purchases had outpaced computers. Physicians are embracing the technology. HIPAA 2018 Changes In this HIPAA session we will be discussing HIPAA 2018 Changes taking place in Washington with the Health and Human Services when it comes to the enforcement of the HIPAA regulations already on the books as well as some step-by-step discussions on the audit method and some current functions regarding HIPAA cases (both in courtrooms and from live audits). Attend this Session What not to Use Do not use the patient's name, initials, or medical record number in the subject line of an email. Also, do not use direct patient identifiers in the message content. This includes: Names Phone numbers Fax numbers Electronic mail addresses Social Security numbers Medical record numbers Health plan beneficiary numbers Account numbers and other personal details HIPAA - Texting & Emailing in 2018 With the introduction of smartphones, emails have become the even more accessible form of communication. In conjunction with email comes the issue of security and them being intercepted and read by unintended persons. Precautions and steps are to be taken at every step of the way. So for a Healthcare concern or a business associate, it's a key to maximize patient communication tools while protecting itself and the organization from government penalties and patient lawsuits. Attend this Session Limit the amount of personal health record information you include in electronic communication. Don't include any highly sensitive information, such as: Mental Illness or Developmental Disability HIV/AIDS Testing or Treatment Communicable Diseases Venereal Disease(s) Substance (i.e., alcohol or drug) Abuse Abuse of an Adult with a Disability Sexual Assault and other sensitive details HIPAA Privacy Officer: Module 1 HIPAA Privacy Officer Training will uncover all HIPAA and HITECH expectations in protecting patient and member's right to privacy and the confidentiality of Protected Health Information (PHI) as you engage in treatment, payment, and healthcare operations (TPO) services. Attend this Session What you need to know before you hit "send" The HIPAA Privacy Rule permits healthcare providers to use e-mail to discuss health issues and treatment with their patients, provided they apply reasonable safeguards when doing so. These precautions are intended to prevent unintentional disclosures of ePHI and may include: Double and triple-checking the e-mail address to ensure accuracy before sending Sending an e-mail to the patient to confirm the address prior to sending any e-mail with ePHI Limiting the type or amount of information disclosed through e-mail, including ePHI Encrypting the e-mail prior to sending Alerting the patient to the relative risks of using unencrypted e-mail to communicate sensitive information, such as the potential for interception by a third party; having the e-mail read by a person with whom the patient has shared their e-mail login and password; accessing private e-mail on a public computer, such as in a library or on a shared computer at work HIPAA Privacy Officer Module: 2 HIPAA Privacy Officer Training will cover all ongoing activities of a Privacy Program related to the development, implementation, maintenance of, and adherence to the organization's policies and procedures covering the privacy of, and access to, patient health information in compliance with federal and state laws and the healthcare organization's information privacy practices. Attend this Session Privacy and Security Require passwords and current antivirus (malware) protection for all devices (pads, laptops, desktops, smart phones) including providers' personal devices. Most smart phone and pad computer users do not use a password, defer to the pre-programmed password or use a simplistic password that is easy to guess. Develop and enforce password requirements. The portability of smart phones and pad computers makes them highly vulnerable to theft, loss and electronic snooping. Inventory all portable devices used by providers to communicate protected health information. Ensure the ability to lock or remote wipe the devices if lost or stolen. Most of the suggestions on e-mailing with patients also apply to text messaging (SMS), where applicable. It should be noted that, while a text message cannot be encrypted, there are third party vendors that offer so-called "HIPAA-compliant" text messaging services, which address the Person or Entity Authentication and the Transmission Security standards of the Security Rule. It is important for practices, providers and patients to understand the risks and benefits of communicating health care information electronically and to mitigate and manage the risks appropriately.....https://www.complyarena.com/articledetails/42

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HIPAA already has many procedures defined which, when followed correctly, will ensure data security. We generally cannot cover everything that needs to be done to safeguard Protected Health Information (PHI). Being HIPAA compliant today doesn't guarantee that you will still be HIPAA compliant tomorrow. HIPAA rules and regulations are changing every day, as technology and security changes. Maintaining HIPAA compliance is an ongoing process and occasionally an external audit of the process or program will help you know your risk areas. Spending a little money now is better than spending a LOT of money in fines later. HIPAA 2018 Changes In this HIPAA session we will be discussing HIPAA 2018 Changes taking place in Washington with the Health and Human Services when it comes to the enforcement of the HIPAA regulations already on the books as well as some step-by-step discussions on the audit method and some current functions regarding HIPAA cases (both in courtrooms and from live audits). Attend this Session Here below are the best ways to safeguard Protected Health Information (PHI) Keep Abreast: Regular training and upgrading of your compliance officers Updating employees knowledge with fully, periodical, updated HIPAA workforce training program Security Policies: Always and at all stages, use multi-level authentication. Read more on Risk based or Adaptive Authentication and use them Access Policies: Fine grained access control should be used to give access and record who can see the data and perform actions HIPAA - Texting & Emailing in 2018 With the introduction of smartphones, emails have become the even more accessible form of communication. In conjunction with email comes the issue of security and them being intercepted and read by unintended persons. Precautions and steps are to be taken at every step of the way. So for a Healthcare concern or a business associate, it's a key to maximize patient communication tools while protecting itself and the organization from government penalties and patient lawsuits. Attend this Session Tracking Logs: Document and audit all actions and functions with immutable time stamps, the audit trails should be immutable and secure from tampering Technical Policies: Use encryption on the data at rest or in database While using a public cloud provider - use HIPAA compliant infrastructure While accessing data ensure using unique user IDs, an emergency access procedure, automatic log off and encryption and decryption Physical Barriers: Physical safeguards should at basic level include limited facility access and control, with authorized access in place HIPAA Privacy Officer: Module 1 HIPAA Privacy Officer Training will uncover all HIPAA and HITECH expectations in protecting patient and member's right to privacy and the confidentiality of Protected Health Information (PHI) as you engage in treatment, payment, and healthcare operations (TPO) services. Attend this Session Business Associate: In case you are a Business Associate, inevitably you will be asked to conduct a security - or risk - assessment by a Covered Entity Technical Safeguard: Technical safeguard required for network, or transmission, security of HIPAA compliant hosts to protect against unauthorized public access of ePHI HIPAA Privacy Officer: Module 2 HIPAA Privacy Officer Training will cover all ongoing activities of a Privacy Program related to the development, implementation, maintenance of, and adherence to the organization's policies and procedures covering the privacy of, and access to, patient health information in compliance with federal and state laws and the healthcare organization's information privacy practices. Attend this Session Perform periodic penetration testing and fix issues and get external audit of the process or program will help you know your risk areas Your HIPAA program must be on - going, reviewed periodically and constantly changing....https://www.complyarena.com/articledetails/Safeguard-Protected-Health-Information-PHI

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