hipaa audit checklist

HIPAA Compliance Checklist Completing a HIPAA compliance checklist should be the first step when assessing whether or not your behavioral health practice is HIPAA compliant. For additional resources regarding the Security Rule requirements Despite the intentionally vague HIPAA requirements, every Covered Entity and Business Associate that has access to PHI must ensure the technical, physical and administrative safeguards are in place and adhered to, that they comply with the HIPAA Privacy Rule in order to protect the integrity of PHI, and that – should a breach of PHI occur – they follow the procedure in the HIPAA Breach Notification Rule. Here is how organizations can be better prepared in the event of a compliance audit or even a breach investigation: HIPAA Compliance for Medical Software Applications, HIPAA Compliance and Cloud Computing Platforms. However, it is essential that you cover every single aspect of it. Before having access to PHI, the Business Associate must sign a Business Associate Agreement with the Covered Entity stating what PHI they can access, how it is to be used, and that it will be returned or destroyed once the task it is needed for is completed. In force since 2003, the Privacy Rule applies to all healthcare organizations, the providers of health plans (including employers), healthcare clearinghouses and – from 2013 – the Business Associates of covered entities. The difference between “required” HIPAA safeguards and “addressable” HIPAA safeguards on our HIPAA compliance checklist is that “required” HIPAA safeguards must be implemented, whereas there is a certain amount of flexibility with “addressable” HIPAA safeguards. Significantly for Covered Entities and Business Associates, it gave the Department of Health and Human Services the resources to investigate breaches and impose fines for non-compliance. It should also be considered that emails containing ePHI are part of a patient´s medical record and should therefore be archived securely in an encrypted format for a minimum of six years. As a result, any entity can self-audit against the HIPAA requirements. All risk assessments, HIPAA-related policies and reasons why addressable safeguards have not been implemented must be chronicled in case a breach of PHI occurs and an investigation takes place to establish how the breach happened. Each of the HIPAA requirements is explained in further detail below. You must also adhere to the requirements of the HIPAA Privacy and Breach Notification Rules. HIPAA is United States federal legislation covering the data privacy and security of medical information. If it is not reasonable to implement an “addressable” safeguard as it appears on the HIPAA compliance checklist, Covered Entities have the option of introducing an appropriate alternative, or not introducing the safeguard at all. Several recent HIPAA breaches have been attributed to criminals obtaining passwords to EMRs or other databases, and healthcare organizations can mitigate the risk of this happening to them with a web content filter. What is a HIPAA Compliance Checklist? HIPAA rules are designed to ensure that any entity that collects, maintains, or uses confidential patient information handles it appropriately. Even if you have hired a dedicated team or personnel to audit your company, you must be aware of the legalities and compliance policy procedures pertinent to your healthcare IT services business. HIPAA Advice, Email Never Shared Communication and access to ePHI is monitored by a cloud-based platform, which has safeguards in place to prevent the transmission of ePHI outside of the healthcare organizations network. True, not every dental practice will get audited, but if your practice is covered by HIPAA you should take these steps anyway. Enforcement discretion will be exercised by OCR and sanctions and penalties will not be imposed on Covered Entities or Business Associates in connection with the good faith participation on the operation of COVID-19 testing sites such as walk-up, drive-through, and mobile sites. It will be far better to find gaps in your compliance program and take steps to correct them than have OCR uncover them and be placed at risk of a compliance penalty. The HIPAA Breach Notification Rule requires Covered Entities to notify patients when there is a breach of their PHI. Onsite audits will be more comprehensive than desk audits and cover a wider range of requirements from the HIPAA Rules. For the sake of clarity: A Covered Entity is a health care provider, a health plan, or a healthcare clearing house who, in its normal activities, creates, maintains or transmits PHI. It also sets limits and conditions on the use and disclosure of that information without patient authorization. A violation due to willful neglect which is not corrected within thirty days will attract the maximum fine of $50,000. Prior to each round of audits, HHS releases a list of what areas of compliance it will focusing on. In this case “access” is interpreted as having the means necessary to read, write, modify, or communicate ePHI, or any personal identifiers that could reveal the identity of an individual. Employers – despite maintaining health care information about their employees – are not generally Covered Entities unless they provide self-insured health cover or benefits such as an Employee Assistance Program (EAP). Ignorance of the HIPAA compliance requirements is not considered to be a justifiable defense against sanctions for HIPAA violations issued by the Office for Civil Rights of the Department of Health and Human Services (OCR). In order to ensure the flow of essential healthcare information is not impeded by HIPAA regulations, and to help healthcare providers deliver high quality care, OCR has announced that penalties and sanctions for noncompliance with certain provisions of HIPAA Rules will not be imposed on healthcare providers and their business associates for good faith provision of healthcare services during the COVID-19 public health emergency. Breach notifications should include the following information: Breach notifications must be made without unreasonable delay and in no case later than 60 days following the discovery of a breach. HIPAA Journal's goal is to assist HIPAA-covered entities achieve and maintain compliance with state and federal regulations governing the use, storage and disclosure of PHI and PII. A violation which occurred despite reasonable vigilance can attract a fine of $1,000 – $50,000. The audit controls required under the technical safeguards are there to register attempted access to ePHI and record what is done with that data once it has been accessed. If users are allowed to access ePHI from their mobile devices, policies must be devised and implemented to govern how ePHI is removed from the devices if the user leaves the organization or the device is re-used, sold, etc. by a skilled nursing facility to medical transport personnel), when required to do so by law (such as to comply with state infectious disease reporting requirements), and to prevent or control disease, injury, or disability. All rights reserved. Go beyond policy. OCR confirmed that the HIPAA Privacy Rule permits disclosures of PHI for the provision of treatment (e.g. Review your business … So, what is the easiest way to become HIPAA compliant? Get anything wrong and fail to safeguard ePHI and, as a HIPAA business associate, you can be fined directly for HIPAA violations by the HHS’ Office for Civil Rights, state attorneys general, and other regulators. Nonetheless, it is in every covered entity´s interests that the integrity of ePHI is safeguarded, and the best way to do that is with a secure messaging solution. Auditors rely on HHS directives to ensure that an organization has adequate resources in place to remedy potential security breaches. A HIPAA audit can review compliance with many different aspects of HIPAA compliance. In the last round of compliance assessments, OCR discovered most of the appraised covered entities did not meet the requirements in the areas of security, privacy, and breach notification. However, it is advisable for all covered entities to be aware of the audit protocol. In order to get ready for a HIPAA audit, healthcare organizations and Business Associates must also develop their own risk management analysis, document data management, security and training plans. These are published on HHs website. This standard has no implementation specifications, so let’s jump right to the key question: What will be the audit control capabilities of the information systems with EPHI? While the EU´s General Data Protection Regulation (GDPR) doesn´t affect HIPAA compliance in any way, it does introduce a further set of regulations for Covered Entities and Business Associates that collect, process, share, or store data relating to EU citizens – for example if an EU citizen receives medical treatment in the USA. The general trends in 2019-2020 for HIPAA compliance seem to be that more Business Associates are paying attention to the HIPAA Privacy and Security Rules. Inappropriate accessing of ePHI by healthcare employees is common, yet many Covered Entities fail to conduct regular audits and inappropriate access can continue for months or sometimes years before it is discovered. This audit checklist will highlight the issues you have. The Rule was introduced due to more Covered Entities adopting technology and replacing paper processes. As medical records can attract a higher selling price on the black market than credit card details, defenses should be put in place to prevent phishing attacks and the inadvertent downloading of malware. Reasonable safeguards must be implemented to protect patient privacy and the security of any PHI used or collected at these sites. Secure messaging solutions allow authorized personnel to communicate ePHI – and send attachments containing ePHI – via encrypted text messages that comply with the physical, technical, and administrative HIPAA safeguards. Business unsure of their obligation to comply with the HIPAA requirements should seek professional advice. If an encrypted device is lost or stolen it will not result in a HIPAA breach for the exposure of patient data. What are the HIPAA Breach Notification Requirements? Any system or software that ‘touches’ ePHI must incorporate appropriate security protections to ensure its confidentiality, integrity, and availability. It is important to note other agencies (for example Centers for Medicare and Medicaid) can take HIPAA enforcement actions, and these may have their own procedures. Among the Security Officer´s main tasks is the compilation of a risk assessment to identify every area in which ePHI is being used, and to determine all of the ways in which breaches of ePHI could occur. That includes disclosures for public health surveillance, and to public health authorities to help prevent or control the spread of disease. The apps can be downloaded to desktop computers and personal mobile devices and work on any operating system. The HIPAA Breach Notification Rule requires Covered Entities and Business Associations to notify the Secretary of Health and Human Services of any impermissible use or disclosure of unsecured Protected Health Information. Like the desk audit, entities will have 10 business days to review the draft findings and provide written comments to the auditor. If you are unsure as to whether your organization is subject to the HIPAA compliance guidelines, you should refer to our “HIPAA Explained” page or seek professional legal advice about what HIPAA compliance means to your organization. Additional policies are required by the HIPAA Security Rule. The HIPAA Compliance Checklist: The Security Rule The HIPAA Security Rule outlines specific regulations that are meant to prevent breaches in the creation, sharing, storage, and disposal of ePHI. The Top HIPAA Threats Are Likely Not What You Think, How to Prepare for a HIPAA Compliance Audit, The Most Common HIPAA Violations You Should Be Aware Of. The auditor will complete a final audit report for each entity within 30 business days after the auditee’s response. The Breach Notification Rule also requires entities to promptly notify the Department of Health and Human Services of such a breach of PHI and issue a notice to the media if the breach affects more than five hundred patients. A HIPAA audit checklist is the ideal tool to identify any risks or vulnerabilities in your healthcare organization or associated business. Maintaining adherence to HIPAA is no small feat considering the dozens of criteria that are considered in the HIPAA Audit Checklist. The Omnibus Rule amends HIPAA regulations in five key areas: Definition changes were also made to the term Business Associate, the term Workforce was amended to include employees, volunteers, and trainees, and the nature of Personally Identifiable Information that is classified as PHI was updated. Incorporation of the increased, tiered civil money penalty structure as required by HITECH. A medical professional with access to a HIPAA-compliant secure messaging app can use it to: Medical professionals located outside of a hospital environment – or those who provide telemedicine services – can securely communicate ePHI “on the go” from any mobile device with secure messaging to save valuable time, increase productivity and enhance the standard of patient healthcare. This function logs authorized personnel off of the device they are using to access or communicate ePHI after a pre-defined period of time. HITECH News Being selected to take part in the survey does not necessarily imply that a covered entity will have to get ready for a HIPAA audit. One element of the HIPAA compliance checklist that is often low down on the priority list is monitoring ePHI access logs regularly. Typically the question following what is HIPAA compliance is what are the HIPAA compliance requirements? Regulatory Changes Criminal charges may also be applicable for some violations. Although it was neither a “required” nor an “addressable” specification that a HIPAA audit checklist was compiled, it makes more sense than ever before to get ready for HIPAA audits with a new round of OCR compliance appraisals about to begin. An employee or contractor can review compliance against the HIPAA requirements, identify any gaps, and remediate them. Prevented the use of PHI and personal identifiers for marketing purposes. Following the passage of the HIPAA Omnibus Rule, in order to be HIPAA compliant, Covered Entities must now: The HIPAA Enforcement Rule governs the investigations that follow a breach of PHI, the penalties that could be imposed on covered entities responsible for an avoidable breach of PHI and the procedures for hearings. Document your remediation plans, put the plans into action, review annually, and update as necessary. This article provides more information about GDPR for US companies. Breach News The HIPAA retention requirements relate to how long Covered Entities must retain HIPAA-related procedures, policies, and other documentation. Notices of Privacy Practices (NPPs) must also be issued to advise patients and plan members of the circumstances under which their data will be used or shared. Collaborate on a patient´s treatment with colleagues. The contingency plan must be tested periodically to assess the relative criticality of specific applications. If issues are found during a physical audit, HHS may require you to initiate a corrective action plan – unless the issues are of a serious nature, in which case the usual penalties for violating HIPAA will apply. Breaches of this nature are easily avoidable if all ePHI is encrypted. There are also procedures to follow with regards to reporting breaches of the HIPAA Privacy and Security Rules and issuing HIPAA breach notifications to patients. The steps you should take for HIPAA compliance depend on the nature of your business and your access to Protected Health Information. Policies must be devised and implemented to restrict the use of workstations that have access to ePHI, to specify the protective surrounding of a workstation and govern how functions are to be performed on the workstations. Administrative controls are in place to avoid the unauthorized access to ePHI when a computer or mobile device is left unattended, and the facility exists to set “message lifespans” on all communications. The HIPAA Omnibus Rule was introduced to address a number of areas that had been omitted by previous updates to HIPAA. Under the Privacy Rule, Covered Entities are required to respond to patient access requests within 30 days. You may submit feedback about the audit protocol to OCR at A HIPAA audit checklist is the ideal tool to identify any risks or vulnerabilities in your healthcare organization or associated business. Clarification of what are consider “good faith” disclosures when a patient is incapacitated. Think from the perspective of the government (or a third-party auditor). It amended definitions, clarified procedures and policies, and expanded the HIPAA compliance checklist to cover Business Associates and their subcontractors. The penalties were originally implemented in the HITECH Act 2009 and increase each year to account for inflation. Different procedures apply depending on the nature of the breach and the number of records disclose without permission. We’ve done our best to make this HIPAA checklist as short as reasonably possible. In most cases, an organization selected for a desk audit will not be selected for a physical audit unless there is a lack of cooperation by the organization during the desk audit. The failure to comply with HIPAA regulations can result in substantial fines being issued – even if no breach of PHI occurs – while breaches can result in criminal charges and civil action lawsuits being filed. The Rule stipulates that HIPAA-covered entities make reasonable efforts to ensure access to PHI is limited to the minimum necessary to accomplish the intended purpose of a particular use, disclosure, or request – and nothing more. The problem is, privacy and security is not the same as a financial audit. There is no hierarchy in HIPAA regulations inasmuch as one HIPAA Rule is more important than another, and each of the criteria in our HIPAA compliance checklist has to be adhered to if your organization is to achieve full HIPAA compliance. Potential lapses in security due to the use of personal mobile devices in the workplace can be eliminated by the use of a secure messaging solution. Receive weekly HIPAA news directly via email, HIPAA News Cancel Any Time. Introduced changes to the harm threshold and included the final rule on Breach Notification for Unsecured ePHI under the HITECH Act. This guideline relates to the devices used by authorized users, which must have the functionality to encrypt messages when they are sent beyond an internal firewalled server, and decrypt those messages when they are received. OCR plans to gather recent data about patient visits, how ePHI is shared electronically, revenues and business locations in order to assess the “size, complexity and fitness of a respondent for an audit”. Before discussing the elements of our HIPAA compliance checklist, it is best to answer the question What is HIPAA compliance? How Should You Respond to an Accidental HIPAA Violation? Although not part of a HIPAA compliance checklist, covered entities should be aware of the following penalties: Fines are imposed per violation category and reflect the number of records exposed in a breach, the risk posed by the exposure of that data, and the level of negligence involved. ” disclosures when a patient is incapacitated of any PHI used or collected at these sites Associates ensure... Developers who build eHealth apps that will transmit PHI for ePHI health surveillance, and theft review BAAs only these... 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