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Exam Code: HIO-201 Practice test 2022 by Killexams.com team
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Killexams : HIPAA Professional history - BingNews https://killexams.com/pass4sure/exam-detail/HIO-201 Search results Killexams : HIPAA Professional history - BingNews https://killexams.com/pass4sure/exam-detail/HIO-201 https://killexams.com/exam_list/HIPAA Killexams : How to Keep Electronic Health Records HIPAA Compliant

If you’re old enough to remember the 1980s, you might recall seeing patients’ notes cataloged in files, faxed, sealed in A4 manilla envelopes, or left on desks for filing. Today, electronic health records (EHRs) must abide by Health Insurance Portability and Accountability Act (HIPAA) precautions, known as the HIPAA Security Rule, to ensure higher levels of patient confidentiality and security.

HIPAA injunctions ensure that only approved individuals can access patients’ health records. For medical practitioners and health institutions, HIPAA-compliant records protect against prohibitive fines, lawsuits, loss of jobs, or premises lockdowns. Appropriately regulated EHRs help people who come into contact with electronic protected health information (ePHI) conform to the HIPAA rules.

We’ll explore HIPAA compliance rules and best practices all healthcare organizations should implement.

What are HIPAA compliance rules?

All healthcare institutions and guardians of HIPAA-protected records are expected to follow four injunctions.

  1. HIPAA privacy: Healthcare entities must implement safeguards to protect the privacy of patients’ electronic protected health information (ePHI). This privacy rule applies to electronic information about the patient, details on their physical or mental health, conversations between a doctor and medical staff, billing information, medical charts, and prescriptions.
  2. HIPAA security: Confidential information can be shared only with authorized stakeholders directly involved with patient care.
  3. HIPAA enforcement: Every person who comes into contact with ePHI must protect this patient data. The HIPAA enforcement rule mainly deals with penalties and investigations when entities are found to be noncompliant.
  4. HIPAA breach notifications: HIPAA breach notifications provide guidelines on what you must do if a breach occurs. Breaches include unauthorized access to ePHI, inadvertent disclosures, stolen or misplaced data, and digital hacks.

How do you apply HIPAA rules to EHRs?

You’ll need to follow some best practices to keep ePHI confidential.

Best privacy practices for HIPAA compliance

  • Thoroughly shred printouts of any patient information. Paper-shredding services can make this process easier and more secure.
  • Encrypt ePHI to make it unreadable.
  • Implement an audit trail, recording whenever someone logged in to ePHI, the place and time they accessed ePHI, and any changes they made.

Best security practices for HIPAA compliance

  • Technical safeguards for securing electronic data include firewalls, antivirus software, a data backup plan and a network security program. Perform all necessary system updates and patches.
  • Administrative safeguards center on collecting, accessing, managing and auditing data. Ensure only authorized users with access controls (e.g., passwords or PINs) can access patient data.
  • Physical safeguards concern how or where you store data to protect it from accidental or deliberate intrusion and environmental or natural disasters.

Best practices to enforce HIPAA rules and prevent ePHI breaches

  • Conduct risk assessments to identify and analyze risks to patients’ information so you can implement safeguards to reduce those risks. Cybersecurity risk assessments include vulnerability scans and penetration tests that scan systems to root out network vulnerabilities.
  • Enforce rules through standardized HIPAA contracts with covered entities (CEs) and stakeholders.
  • Draft policies and procedures. When CEs draft written policies and procedures on HIPAA compliance and train their staff on how to follow these rules, they can avoid HIPAA breach notifications. Update your policies and procedures periodically and redraft written documents every six years.

Did you know?Did you know? While HIPAA laws impact employers who are CEs, other employers have privacy and security obligations under federal laws like the Americans with Disabilities Act and the Family and Medical Leave Act (FMLA).

What is an electronic health record (EHR)?

When doctors, medical practitioners, healthcare insurers, billers, or anyone involved with patient care and payment processing document and review a patient’s case, they create and add to the patient’s medical records. An electronic health record, or EHR, is a digital version of these patient documents.

EHRs are computer logs containing sensitive patient health information (PHI), including patient-related billing, conversations, forms, charts and prescriptions – anything related to the patient’s medical treatment and mental or physical health.

Practitioners refer to the EHR to schedule or revise consultations, order prescriptions, or educate themselves on the patient’s history. Medical billing and coding departments refer to ePHIs to pay doctors and healthcare institutions.

Who must comply with HIPAA rules?

HIPAA injunctions apply to all CEs who electronically transmit healthcare information:

  • Any healthcare provider or health plan that uses EHRs and technical devices to process ePHI is subject to HIPAA injunctions.
  • Healthcare clearinghouses mediate between healthcare providers and insurers. If they’re involved with billing, repricing, or overseeing community health management information services, they’re subject to HIPAA injunctions.
  • Business associates that provide services to healthcare entities – and may therefore be exposed to ePHI – are subject to HIPAA injunctions.
  • Contracted business associates or similar non-workforce members who perform tasks for healthcare entities and are exposed to ePHI are subject to HIPAA injunctions.

TipTip: To use telemedicine and stay HIPAA compliant, choose a secure telehealth solution, limit access to sensitive information, and develop a cybersecurity strategy.

6 essential HIPAA practices for EHRs

Follow these best practices to ensure compliance with HIPAA EHR rules:

  1. Use safe storage. Store all electronic systems and patient-related records in a locked, monitored area.
  2. Power down devices. Turn off electronic devices when not in use, or implement a robust medical records management system with an automatic time-out setting.
  3. Use a firewall. Install firewall protection to deter hackers from accessing patient records.
  4. Have a backup system. Make backups of your ePHIs, and consider storing them with one of the best cloud storage and online backup services.
  5. Shred old records. Shred dated medical records to reduce the risk of breaches.
  6. Train your staff. Train any staff members who work with your EHRs to handle these confidential records correctly.

TipTip: If you’re considering implementing a medical records management system, check out our reviews of the best medical software offering HIPAA compliance tools and strong security.

HIPAA-EHR compliance tips for remote workers

More employees are processing confidential information from their homes. To avoid HIPAA-compliant violations, remote workers should adhere to these best practices:

  1. Work in a private, secure place. Don’t work on HIPAA-sensitive projects in public. People could snoop over your shoulders and read the data. Even worse, malicious actors use wireless devices and powerful antennas to pick up unsecured wireless networks. They could hack into the confidential electronic data in your care and gain unrestricted access to private medical information.
  2. Use a VPN. Use a virtual private network (VPN), particularly if you work in a public place such as a hospital or airport. VPNs encrypt your public data, scrambling it from snooping individuals.
  3. Keep patient data off the calendar. Take care not to misuse patient data when using a digital calendar or drafting digital notes. A Google task reminder to process Jane Doe’s July appointment could land you in hot water.
  4. Take precautions when faxing. To protect private data, use a cover sheet when faxing patient information.
  5. Ensure a secure internet connection. To ensure a secure internet connection, you need the WPA3 encryption protocol with its Wi-Fi Enhanced Open Mode option for increased security on unsecured networks.
  6. Create strong passwords. Use strong passwords a crook can’t crack. Experts recommend using passwords with upper- and lower-case numbers, symbols and letters. Create different passwords for personal and business devices; if you write them down, keep them in a safe place, like your wallet.
  7. Use up-to-date antivirus software. Keep your antivirus and anti-malware software up to date. Some of the best antivirus software includes Kaspersky, Bitdefender, Avast, Norton and ESET.
  8. Use a firewall. Install firewalls on computers, devices and routers to protect your ePHI. You may also want to use software scanners, like Vistumbler or Airodump-ng, to search the airwaves of your home for foreign Wi-Fi signals that could pick up this ePHI.
  9. Think before you click. Foil phishing attempts by not clicking on suspicious email links. Double-check seemingly familiar email addresses for subtle irregularities. Steer clear of suspicious ads, websites, links and messages. Any promotion that sounds too good to be true probably is.
  10. Change or conceal your SSID (service set identifier). Your Wi-Fi network SSID is listed among other local networks on your wireless-enabled device. Either change its name to mislead would-be hackers or remove your SSID from the network list. At the very least, disable the SSID in public settings when anyone with wireless technology can pick up your signals.
Sun, 27 Nov 2022 10:00:00 -0600 en text/html https://www.business.com/medical-software/hipaa-compliance/
Killexams : 5 Former Methodist Hospital Employees Indicted Over HIPAA Violations No result found, try new keyword!November 16, 2022 - Five former employees of Tennessee-based Methodist Hospital have been indicted by a federal grand jury for committing HIPAA violations, the US Attorney’s Office for the ... Wed, 16 Nov 2022 15:28:00 -0600 en-US text/html https://healthitsecurity.com/news/5-former-methodist-hospital-employees-indicted-over-hipaa-violations Killexams : Privacy Basics: A Quick HIPAA Check for Medical Device Companies

Regulatory Outlook

HIPAA

HIPAA, which was enacted in 1996, had many different goals, including making insurance transferable upon leaving employment, enabling electronic billing for medical costs, and, the most famous result, the authorization of federal privacy rules for health information. The Department of Health and Human Services (HHS) then made two regulations: the HIPAA privacy rule, which regulates private health information, and the HIPAA security rule, which regulates the manner in which healthcare providers control and protect health information.

Covered Entities

The organizations controlled by the HIPAA privacy regulation are called covered entities. A covered entity is any healthcare provider that electronically bills for its services. This covers almost all healthcare professionals. It also means that most medical device companies are not covered entities. However, some medical device firms that sell to patients and bill Medicare may qualify as covered entities and be bound by HIPAA. For example, a company that sells insulin pumps to patients and bills Medicare would be a covered entity. Some companies may have a subsidiary that is a covered entity while the rest of the company is not covered; such companies are called hybrids. The company can wall off the subsidiary, which is a covered entity, so that only that part of the company is bound by HIPAA.

Covered Information

HIPAA defines the covered information as PHI, which is any health-related information that may identify a patient. HIPAA takes an expansive view of what may identify a person. There is a list of 18 identifiers. Besides the traditional identifiers such as name, address, phone number, social security number, etc., there are some device-related identifiers, such as serial number or date of service when the device was used, that have proven quite to difficult to deidentify.

Almost any information from a patient file has to be carefully scrutinized to be sure it is not PHI. The definition is wider in the United States than it is in the European Union (EU), where more-traditional identifiers are used. Member nations of the EU are governed by the EU Directive on Data Privacy.

Disclosure of PHI

Authorization is the term used for a patient to allow some disclosure or use of PHI. HIPAA determines authorized uses of PHI by covered entities and what disclosures of PHI may be made. The HIPAA privacy regulation outlines when a covered entity must obtain authorization from the patient or approval from an institutional review board (IRB) or privacy board.

Note that the EU uses the term consent for this document while HIPAA uses authorization. For device companies, there may be an informed consent document created to comply with FDA clinical rules or the HHS Common Rule. This consent document may have a HIPAA authorization built into it, but the HIPAA authorization is not called a consent.

With several exceptions, a covered entity may use PHI within its organization without restriction by HIPAA. However, when it discloses information outside its boundaries, the covered entity must comply with the HIPAA privacy regulation's limitations and authorization requirements. The covered entity may disclose to third parties without authorization for three HIPAA-specified activities: treatment, payment, or healthcare operations (TPO).

Treatment. Treatment refers to communication of PHI needed to treat the patient, such as information flow between the covered entity and another healthcare provider, e.g., another doctor who is treating the patient. A general practitioner and a specialist may discuss their joint patient for the purpose of treatment without activating any authorization requirements under HIPAA. This treatment exception could involve a medical device company. For example, if a technical representative from a medical device company takes part in a surgery to help use or train surgeons on the company's equipment, that participation is part of treatment and does not require an authorization. Although it is wise to notify the patient before exposing his or her data or personal information to a company representative, there is no specific HIPAA requirement to do so under these circumstances.

Payment. Payment refers to the process of obtaining payment from payers such as insurance carriers. Although covered entities routinely ask for consent to disclose information to payers, and there may be consent requirements at the state level, there is no need for a HIPAA authorization for billing.

Healthcare Operations. The term healthcare operations refers to the internal mechanics of running the covered entity. PHI may be transmitted as part of normal business operations. For example, the covered entity may use PHI for internal quality assurance improvement practice.

Business Associates

Sometimes a covered entity receives assistance in performing activities that involve the use or disclosure of PHI under HIPAA. The person or entity providing the help is called a business associate. A covered entity may enter a business associate agreement (BAA) with another person or company that is providing services to the covered entity with regard to TPO. For example, the covered entity might outsource its billing department to a third party. In such a case, the covered entity would engage that biller with a BAA.

It is very unusual for a medical device company to need a BAA with any covered entity. In the early days of HIPAA, covered entities were wholesale shipping BAAs to everyone they purchased from. Since then, HHS has made it clear that the normal relationship between a medical device provider and a covered entity does not require a BAA.

It is only when a medical device company is acting on behalf of a covered entity that it needs a BAA. One narrow example is when a covered entity is prescreening patient records in preparation for research. It can do that without an authorization. However, if the covered entity allows a third party, such as a device company, onto its property to do such preliminary searching on the covered entity's behalf, it may then need a BAA to protect the PHI that the device company will access.

Access to PHI

There are a number of access points to PHI for a device company. Some information is necessary for the device company to have and some is thrust upon it. Common ways to be exposed to PHI include the following.

Treatment. As a device company, you have a role in treatment. For example, as previously discussed, a device company representative may attend the actual use of a device. Or, a doctor may call the OEM's technical services staff with questions about how a particular patient's anatomy or medical symptoms could affect the use of the company's device. Even though no name is given, the medical data may include HIPAA identifiers. Such treatment interactions between the medical device company and the covered entity are part of the treatment exception to HIPAA and therefore require no special authorization.

Accidental Exposure. A device company field representative may accidentally be exposed to PHI while at the site of a covered entity. For example, the representative might inadvertently see a patient chart while in a doctor's office. HIPAA calls this incidental disclosure. HIPAA allows such action without any repercussions under the regulation. Remember that PHI is still private and the company representative should not disclose what is accidentally seen to anyone else.

Clinical Trial or Other Research Information. There are three main routes for obtaining PHI from a covered entity for research: authorization, partial waiver from an IRB, or deidentification.

The most common way to obtain research data is through patient authorization. An authorization is built into the informed consent document in most medical device clinical trials. Once a company is in the process of having a patient sign a consent form, it is not much extra work to include the additional elements required for a HIPAA-compliant authorization. This method makes it possible to obtain wider access to use of the data. Most device companies want to harness the data to Strengthen future generations of devices and not just the immediate use. Such usage can be accounted for in a signed authorization.

A partial waiver means asking an IRB to allow PHI of a limited nature to be disclosed without a patient's authorization. For example, the site could strip out all directly identifiable information such as names, addresses, etc. The remaining identifiers might technically identify the patient, but the IRB may determine that the risk is low and allow disclosure without patient authorization. However, this process has proven difficult in practice simply due to the bureaucracy that has to be managed; companies have found the IRB interface to be too slow and laborious to use often.

Deidentification requires removing all 18 identifiers from the PHI, which can be difficult for device research. For example, because device serial numbers are often needed to correlate to other records, they are a hard identifier to do without. Similarly, dates of visits are often needed to correlate to device performance over time. However, deidentification is still a viable option for some research.

Compliance with FDA Regulations. A specific section of the HIPAA privacy regulation allows a covered entity to disclose information to a device manufacturer in order for the manufacturer to report to a public health agency, such as FDA. This exception is crucial because it allows a covered entity to communicate with a manufacturer to follow up on a complaint, provide data for a medical device report, track devices, or use information needed for quality system regulation compliance.

PHI after Disclosure

Once outside a covered entity, HIPAA rules no longer apply to this information. In fact, this must be stated in every HIPAA authorization. However, there are myriad state laws that control PHI in different forms, and if the PHI is obtained under a BAA, there are contractual obligations as well. Therefore, a device company should only take PHI when needed and must safeguard it, i.e., only those who truly need access to PHI should be allowed to see it. Device companies must also establish procedures to prevent accidental disclosure.

Conclusion

HIPAA has definitely made research more difficult for device companies. Each time that a company considers accessing PHI, it needs a thorough HIPAA analysis. Initially, device companies feared that the public health exemption was not broad enough and that covered entities would resist releasing the necessary PHI. However, over time, covered entities have cooperated and have generally allowed access to PHI that device companies need for compliance with FDA regulations. Therefore, life is more difficult with HIPAA, but certainly not impossible.

Copyright ©2009 Medical Device & Diagnostic Industry

Sun, 04 Dec 2022 10:00:00 -0600 en text/html https://www.mddionline.com/news/privacy-basics-quick-hipaa-check-medical-device-companies
Killexams : HHS Proposes New Rule to Align 42 CFR Part 2 With HIPAA No result found, try new keyword!The proposed changes are aimed at better aligning Part 2 with HIPAA, as required by Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Ideally, the changes will ... Tue, 29 Nov 2022 17:40:00 -0600 en-US text/html https://healthitsecurity.com/news/hhs-proposes-new-rule-to-align-42-cfr-part-2-with-hipaa Killexams : DOJ Prosecutes Physician and Pharmaceutical Sales Representative for Criminal HIPAA Scheme

Tuesday, November 29, 2022

Most violations of the Health Information Portability and Accountability Act (HIPAA) are addressed through administrative enforcement action. But, in some circumstances of improper conduct affecting the privacy or security of patient information, the federal government may criminally punish the parties involved. 

Two latest prosecutions for criminal conspiracy to violate HIPAA are a stark reminder of the legal boundaries that HIPAA imposes on the sharing of patient information between a health care provider and a pharmaceutical company. 

In October of 2022, federal prosecutors in New Jersey announced that a physician with medical practices in New Jersey, New York, and Florida and a pharmaceutical sales representative each pleaded guilty to conspiring to wrongfully disclose and obtain patient information in violation of HIPAA’s criminal prohibitions. According to charges by the US Department of Justice (DOJ) in a superseding information, the unlawful information-sharing aided the submission of false and fraudulent insurance claims for compound prescription medications that the Sales Rep, who also pleaded guilty to conspiracy to commit health care fraud, arranged in exchange for commission payments.

As part of the conspiracy to violate HIPAA, the Sales Rep had virtually unfettered access to patient information at the Physician’s medical practice, the DOJ alleged. In staff-restricted areas of the Physician’s office during and outside normal business hours, the Sales Rep pored through patient schedules and charts to flag patients with insurance coverage for the marketed compound medications. On some occasions, the Physician allowed the Sales Rep to be present during appointments with patients, without revealing that the Sales Rep did not work for the practice. On others, the Sales Rep met with patients by himself and obtained information he used to fill out prescriptions that the Physician later authorized. The DOJ alleged that, in all of these instances in which the Sales Rep gained access to patient information, the Physician lacked patient authorization or another lawful basis under HIPAA to disclose the information.

For health care providers and pharmaceutical manufacturers alike, the outcome of these cases raises important HIPAA compliance questions. When, if ever, may a health care provider disclose patient information to a pharmaceutical manufacturer and its sales agents? And in what circumstances does an unauthorized disclosure of patient information rise to the level of a crime?   

How Pharmaceutical Manufacturers Fit Within the HIPAA Framework

HIPAA regulates the use and disclosure of “protected health information” (PHI). Its regulatory requirements apply to health care providers, health plans, and certain other parties that meet the criteria of a “covered entity.” In general, a covered entity may use or disclose PHI only as HIPAA expressly requires or permits. These restrictions are intended to protect the privacy and security of patients’ information. 

In contrast to physician practices, hospitals, and other health care providers that prescribe or purchase pharmaceutical products, the manufacturers of those products typically are not covered entities. Thus, pharmaceutical representatives do not generate or require access to PHI while performing many of their job functions. However, HIPAA does contemplate some situations when a pharmaceutical manufacturer and its personnel may have a legitimate need for PHI from a covered entity. 

For example, under what is referred to as HIPAA’s “public health provision” (codified at 45 CFR § 164.512(b)), a covered entity may disclose PHI to a pharmaceutical manufacturer for the purpose of “activities related to the quality, safety or effectiveness” of a product or activity regulated by the US Food and Drug Administration (FDA). Such PHI-sharing activities are permitted to support collection or reporting of adverse events, product recalls, or post-marketing surveillance, among other purposes. 

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR), which enforces HIPAA through the imposition of administrative sanctions, explained in agency guidance that HIPAA’s public health provision is “intended to facilitate the flow of information that is essential to the FDA’s public health mission.” This does not, however, permit a covered entity to disclose PHI “to a manufacturer for the manufacturer’s commercial purposes, or for any other non-public health purpose.” For example, OCR noted that a covered entity may not “provide a drug manufacturer with a list of persons who prefer a different flavored cough syrup over the flavor of the manufacturer’s product.”

When a HIPAA Violation Becomes a Crime

An unauthorized use or disclosure of PHI may prompt administrative enforcement action by OCR against the covered entity. In the majority of cases of HIPAA noncompliance, OCR will first attempt informal resolution by obtaining voluntary compliance through corrective action. Such corrective action may take the form of a resolution agreement, which may require payment of a settlement amount and implementation of a corrective action plan. If OCR and a party do not mutually agree to a resolution agreement, or if a party violates the terms of a resolution agreement, OCR may impose a civil monetary penalty.

If OCR receives a complaint or learns of another event that implicates the criminal provision of HIPAA, OCR may refer the matter to DOJ for investigation. Under 42 USC § 1320d-6, a person faces imprisonment for up to one year and/or a fine of up to $50,000 for knowingly and in violation of HIPAA: (1) using or causing to be used a unique health identifier; (2) obtaining individually identifiable health information (IIHI, which is a component of the definition of PHI) relating to an individual; or (3) disclosing IIHI to another person. Additional penalties apply if a person commits the offense under false pretenses or with intent to sell, transfer, or use IIHI for commercial advantage, personal gain, or malicious harm.

In 2005, the DOJ Office of Legal Counsel, which provides legal advice to the president and federal executive agencies, issued a legal opinion to HHS interpreting the scope of DOJ’s criminal HIPAA enforcement authority. In that memo, DOJ concluded that only covered entities, along with certain directors, officers, and employees of those entities, are prosecutable for a statutory violation. Other parties not directly liable under the statute, however, may still be prosecuted for aiding and abetting or participating in a conspiracy with a covered entity to commit a criminal HIPAA violation. Thus, as the latest conviction of the Sales Rep demonstrates, the representative of a pharmaceutical manufacturer may be punished for participating in a criminal HIPAA conspiracy, even if the manufacturer is not a covered entity.   

Patient Information-Sharing Between Physician and Sales Rep Was Part of Larger Fraud Scheme Involving Compound Drug Claims 

According to DOJ’s superseding information against the Sales Rep, the criminal HIPAA conspiracy between the Physician and Sales Rep facilitated another criminal fraud conspiracy between the Sales Rep and several executives from a pharmacy in Louisiana to profit off prescriptions for compound medications that the Sales Rep promoted and the pharmacy dispensed. To this end, the Sales Rep generated prescriptions from the Physician for patients whom the Rep earmarked or recruited, using patient information from the Physician’s medical practice, as having prescription drug insurance benefits administered by a pharmacy benefits manager that would pay for those medications. For each prescription the Sales Rep arranged, the pharmacy paid him a portion of the payment it collected.

Both the Physician and Sales Rep could be imprisoned for up to one year and fined up to $50,000 for the criminal HIPAA conspiracy to which they pleaded guilty. Additionally, the Sales Rep could be imprisoned for up to 10 years and fined up to $250,000 on the health care fraud conspiracy count. Sentencing for both defendants is scheduled to occur in February of 2023.

Key Takeaways

The prosecutions of the Physician and Sales Rep follow a latest pattern of similar cases in which DOJ charged defendants for offenses involving unlawful disclosures of patient information to pharmaceutical sales agents. These enforcement actions should alert covered entities and their workforce members to the risks of HIPAA’s criminal penalties. Although physician practices and other covered entities may have legitimate, permissible reasons for disclosing PHI to pharmaceutical manufacturers and their representatives, they should exercise caution when engaging in such information-sharing practices. 

As the Sales Rep’s prosecution underscores, pharmaceutical manufacturers should be mindful of additional fraud and abuse risks that may arise from the unauthorized access and use of PHI, particularly where a company or salesperson has a strong commercial incentive to acquire PHI. Indeed, many of the alleged activities that the Sales Rep undertook involving access to PHI, such as reviewing records to confirm insurance coverage for the marketed products, are activities that the HHS Office of Inspector General (OIG) warned in its Compliance Program Guidance for Pharmaceutical Manufacturers could implicate the Anti-Kickback Statute.

To minimize these regulatory risks, HIPAA covered entities that allow visits to their facilities by pharmaceutical sales reps should develop staff training programs and policies to ensure those visits are conducted properly. Items to address may include, for example, authorized locations where sales reps may be present, interactions with patients, and safeguards for PHI. Likewise, manufacturers should maintain similar programs and policies to govern the conduct of their representatives when interfacing with health care providers, drawing from OIG’s compliance program guidance and other industry compliance resources, such as the PhRMA Code on Interactions with Health Care Professionals. Even if they are not covered entities themselves, many pharmaceutical manufacturers may benefit from incorporating HIPAA training and privacy policies into their compliance programs.  

Mon, 28 Nov 2022 10:00:00 -0600 en text/html https://www.natlawreview.com/article/doj-prosecutes-physician-and-pharmaceutical-sales-representative-criminal-hipaa
Killexams : HHS Proposes to Align Federal Substance Use Disorder Law with HIPAA

Wednesday, November 30, 2022

Proposed changes to the federal substance use disorder law will increase provider efficiency and alignment with the Health Insurance Portability and Accountability Act (HIPAA). In a move that seeks to decrease administrative burdens on patients and providers while beefing up enforcement capabilities, the Department of Health and Human Services (HHS) issued its long awaited Notice of Proposed Rulemaking (Proposed Rule) for the proposed changes to 42 C.F.R. Part 2 (Part 2), the regulation governing the confidentiality of substance use disorder patient records. The changes have been expected since 2020 when Congress directed HHS to amend Part 2 in the CARES Act. The Proposed Rule’s impact will be a net positive for substance use disorder providers already required to comply with HIPAA. However, cash-pay providers required to comply with Part 2 but not regulated by HIPAA will be required to comply with HIPAA’s Privacy Rule and Breach Notification Rule.

“HHS understands how critical it is for patients to better align the Part 2 rules and program with HIPAA. This proposed rule helps decrease burdens on patients and providers, improves coordination and increases access to care and treatment, while protecting confidentiality of treatment records.” - OCR Director Melanie Fontes Rainer (Nov. 28, 2022)

Here are six key takeaways from the Proposed Rule.

  1. Single patient consent for all treatment, payment, and operations disclosures. The most anticipated change to Part 2 is the easing of the ability to share Part 2 records for purposes of treatment, payment, and health care operations (TPO). Part 2 programs will be able to obtain a single consent from a patient that permits disclosure for all future TPO uses and disclosures. The proposed rule will allow patients flexibility when identifying recipients. For example, it will be permissible to list categories of recipients on the consent, such as “my treating providers, health plans, third-party payers, and people helping to operate this program” or a similar statement. Once the consent, which will look similar to a HIPAA authorization, is obtained, Part 2 programs, covered entities, and business associates that receive Part 2 records pursuant to a written consent for TPO purposes may redisclose the records in any manner permitted by the HIPAA Privacy Rule, except for certain proceedings against the patient.

  2. Part 2 violations will be subject to the HIPAA Breach Notification Rule. The proposed rule would add breach notification requirements to Part 2 through a cross-reference to the HIPAA Breach Notification Rule. This change would require Part 2 programs to notify HHS, affected patients, and in some cases the media, of a breach of unsecured Part 2 records in accordance with the HIPAA Breach Notification Rule. While the majority of Part 2 programs are also covered entities that will already be familiar with these requirements, any Part 2 programs not currently subject to HIPAA will need to develop a robust privacy compliance program and train their workforce to identify disclosures that may trigger a breach notification requirement.

  3. Self-pay patients have the right to restrict disclosures to health plans. Similar to HIPAA, the proposed rule would require Part 2 programs to permit patients to request restrictions on the use or disclosure of Part 2 information to carry out TPO. This includes instances when the patient has signed a written consent for the disclosures. Part 2 programs are not required to agree to these restrictions, except in the event the patient has requested to restrict disclosure of records to a health plan for payment or health care operations purposes where the record pertains solely to a health care item or service for which the patient or someone on the patient’s behalf, other than the health plan, has paid the Part 2 program in full.

  4. Part 2’s Patient Notice requirements are aligned with HIPAA’s Notice of Privacy Practices. The proposed rule would ensure that patients of Part 2 programs are afforded the same level of notice and transparency as is provided to individuals through HIPAA’s Notice of Privacy Practices (NPP). Currently, Part 2 programs are required to provide a written “summary” of Part 2’s restrictions to patients, but Part 2 does not require such programs to provide a comprehensive NPP to patients. Under the proposed rule, the Part 2 patient notice (Patient Notice) would address the same key elements as the HIPAA NPP, including a description of the permitted uses and disclosures of Part 2 records (and when separate consent is required). The Patient Notice would also need to inform patients of the complaint process and the patient’s right to revoke their consent for the Part 2 program to disclose records in certain circumstances.

    Notably, the proposed rule would modify both Part 2’s Patient Notice requirements and HIPAA’s NPP requirements. Certain covered entities that are not Part 2 programs but receive and maintain Part 2 records (and are thus subject to Part 2 requirements for those records) would need to add a provision to their NPP that references the restrictions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings against the individual. Current NPP requirements would continue to apply, without change, to covered entities that do not maintain or receive Part 2 records.

  5. New Part 2 accounting of disclosures requirements tolled until the issuance of the long-awaited HIPAA final rule on accountings. HHS proposes to incorporate HIPAA’s accounting requirements into Part 2. The proposed rule would also incorporate the requirements in the HITECH Act that disclosures for TPO purposes be included in the accounting only where such disclosures are made through an electronic health record. The compliance date for the Part 2 accounting requirement would be tolled until the effective date of a (long awaited) final rule on the HIPAA accounting of disclosures standard.

  6. HHS will have the authority to enforce Part 2 through civil penalties. The CARES Act replaced the previous criminal enforcement authority for violations of Part 2 with a reference to the statutory penalties that apply to HIPAA violations. The proposed rule would update the Part 2 regulations to reflect this change, creating for the first time a civil enforcement authority that may be exercised by HHS in addition to the Department of Justice’s longstanding criminal enforcement authority. The Proposed Rule notes that there have been no criminal actions undertaken to enforce Part 2. Given that HHS has significant experience investigating and enforcing HIPAA violations through civil penalties, we would expect to see HHS take a similar approach with regard to Part 2.

Make Your Voice Heard

Public comments on the Proposed Rule are due 60 days after publication of the Proposed Rule in the Federal Register, which is expected on December 2, 2022. Note that the current Part 2 rules remain in effect while HHS undertakes this rulemaking process.

© 2022 Foley & Lardner LLPNational Law Review, Volume XII, Number 334

Tue, 29 Nov 2022 10:00:00 -0600 en text/html https://www.natlawreview.com/article/hhs-proposes-to-align-federal-substance-use-disorder-law-hipaa
Killexams : What is HIPAA?

What is HIPAA?

HIPAA stands for the Health Insurance Portability and Accountability Act

HIPAA is a federal law covering healthcare and health insurance industries. It addresses a number of subjects and mandates that PHI (also referred to ePHI if it is in electronic form) must be protected in order to maintain the privacy and confidentiality of patients’ medical information. This mandate is addressed in two key HIPAA provisions: the Privacy Rule and the Security Rule.

PHI

PHI is individually identifiable health information, including demographic information, that is:

  • Created, received, transmitted, or maintained by a healthcare provider, health plan, or healthcare clearinghouse
  • Relates to the past, present, or future physical or mental health or condition of an individual
  • Relates to the provision of health care to an individual
  • Relates to the past, present, or future payment for the provision of healthcare to the individual
  • Can be used to identify the individual.

HIPAA mandates that PHI must be protected in both physical and digital form. Such information is classified as Restricted/PHI by UAB’s Data Classification Rule. Examples of HIPAA/PHI data that must be protected include names, address, dates, phone numbers, email addresses, SSNs, account numbers, photos, etc.

PHI can appear in a number of different formats. Examples of media on which PHI can appear include, but are not limited to, the following:

  • Written documentation and all paper records, including prescription labels and ID bracelets
  • Spoken and verbal information, including discussions with or about patients, and voice mail messages
  • Electronic information stored on a computer, laptop, mobile device, USB drive, or other electronic media
  • X-rays, photographs, and digital images

Requirements

Privacy Rule

The HIPAA Privacy Rule states that PHI may be used and disclosed to facilitate treatment, payment, and healthcare operations (TPO). When HIPAA permits the use or disclosure of PHI, the covered entity must use or disclose only the minimum necessary PHI required to accomplish the business purpose of the use or disclosure. Even when PHI is used or disclosed for appropriate business purposes, if the PHI is not limited to the necessary minimum, it is a HIPAA violation. The only exceptions to the necessary minimum standard are those times when a covered entity is disclosing PHI for the following reasons:

  • Treatment
  • Purposes for which a patient authorization is signed
  • Disclosures required by law
  • Sharing information to the patient about himself/herself

Security Rule

The Security Rule and its associated regulations contain 18 standards that must be met in order to provide the appropriate security safeguards to protect the confidentiality, integrity, and availability of patients’ PHI. These regulations address a number of issues regarding the protection of PHI. Examples of such issues include, but are not limited to, prohibiting downloading or copying of PHI, conducting risk assessments at least every two years, requiring the encryption of all hard drives containing PHI, etc.

To ensure that the requirements of the Security Rule are met, UAB has adopted a set of Security Core Policies and the Data Protection Rule which describes security requirements that must be followed.

PHI and Third Parties

A covered entity can share PHI with a third party, but that party must be an authorized Business Associate (BA) and there are requirements and stipulations on how PHI can be shared. Examples of BAs include an electronic patient record vendor or a company that shreds physical media that contain PHI.

In order to share PHI with a BA, a UAB covered entity must execute a signed Business Associate Agreement (BAA) with the third party before the PHI can be shared.

For more on HIPAA, BAs and BAAs, and the associated forms, visit UAB’s HIPAA web site. Note: Users must be on either the UAB or UABMC network to access this site.

Penalties

The Department of Health and Human Services (HHS enforces a tiered civil penalty system for non-compliance with the HIPAA Privacy Rule and Security regulations. The following actions could occur should a non-compliance issue arise:

  • Monetary penalties that range from $100 to $1.65 million per violation could be assessed, depending on the circumstances.
  • HHS must investigate any complaint that could possibly result from a violation due to willful neglect and must impose penalties if such neglect is confirmed. “Willful neglect” is defined as “conscious, intentional failure or reckless indifference to the obligation to comply” with HIPAA.
  • State attorneys general also can pursue civil suits against persons who violate HIPAA.

The U.S. Department of Justice is responsible for enforcing criminal penalties for non-compliance with the HIPAA Privacy Rule. Criminal penalties for “wrongful disclosure” include both large fines of $50,000 to $250,000 and up to 10 years in prison. Examples of wrongful disclosures include accessing health information under false pretenses, releasing patient information with harmful intent, or selling PHI.

Note: Penalties and fines apply to members of the workforce and other individuals, not just to the covered entities.

In addition to the federal and state penalties and fines, members of the UAB/UABHS workforce are subject to disciplinary action, up to and including termination of employment or assignment, for non-compliance with HIPAA privacy and security regulations, policies, and procedures.

Core Policies

Sat, 22 Aug 2020 06:42:00 -0500 en-US text/html https://www.uab.edu/it/home/policies/compliance/hipaa
Killexams : Former Methodist employees charged with HIPAA violations

MEMPHIS, Tenn. — Five former Methodist Hospital employees have been charged with HIPAA violations, according to the United States Department of Justice.

Kirby Dandridge, Sylvia Taylor, Kara Thompson, Melanie Russell, and Adrianna Taber were indicted by a federal grand jury in Memphis.

According to the DOJ, the indictment states that between November 2017 and December 2020, a man identified as Roderick Harvey paid the Methodist Hospital employees to provide him the names and phone numbers of patients who had been involved in motor vehicle accidents.

The DOJ says Harvey then sold that information to other people, including personal injury attorneys and chiropractors.

Dandridge, Taylor, Thompson, Russell, and Taber have all been charged with violating HIPAA by disclosing that information to Harvey.

Rachel Powers Doyle, spokesperson for Methodist Le Bonheur Healthcare, released a statement on the case.

At Methodist Le Bonheur Healthcare, we take the security of our patient’s private information very seriously. Once we became aware of the situation, we promptly took action and alerted the appropriate legal authorities. We’ve cooperated fully with their investigation and ensured each patient who was affected has been notified. While there is no evidence of financial information being disclosed, we are offering free credit reporting for those affected.

The Health Insurance Portability and Accountability Act of 1996, otherwise known as HIPAA, protects patient information from being released without the patient’s knowledge or consent.

The DOJ says HIPAA violation charges carry a maximum penalty of one year in prison, a $50,000 fine, and one year of supervised release.

Harvey has been charged with seven counts of obtaining patient information with the intent to sell it for financial gain from November 12, 2017, to September 7, 2019. The DOJ says each of the charges carries a maximum of 10 years in prison, a fine of $250,000, and three years of supervised release.

The DOJ says the FBI and TBI investigated the case.

Thu, 10 Nov 2022 04:39:00 -0600 en-US text/html https://wreg.com/news/local/former-methodist-employees-charged-with-hippa-violations/
Killexams : How HIPAA and Other Health Privacy Laws Work Together to Protect Employee Health Information How HIPAA and Other Health Privacy Laws Work Together to Protect Employee Health Information

How HIPAA and Other Health Privacy Laws Work Together to Protect Employee Health Information

With technology always changing, it's important for employers to learn how to protect employee information.

Protecting patient and employee health information has become more complex. Technology is, and likely always will be, a fundamental part of the healthcare system. While computers make it easier for teams to manage records, any online document could fall victim to a cyberattack.

In the healthcare industry, the Health Insurance Portability and Accountability Act (HIPAA) ensures patient confidentiality. For employers, it’s unclear whether HIPAA laws apply to their employee health records or what types of medical information are considered “confidential.”

To protect the health and safety of your employees, you must abide by American privacy laws, which may or may not include HIPAA, while also following a few security-based best practices.

What is HIPAA, and Does it Apply to Non-Healthcare Employers?

HIPAA is a set of national standards for the protection of health information. These standards apply to covered entities, which include health plans, healthcare clearinghouses and healthcare providers who electronically transmit medical information (unless it’s for employer use).

Non-healthcare employers do not have to abide by HIPAA law, but most states use HIPAA as a standard for identity theft protection laws or cybersecurity laws, so you aren’t out of the woods.

For example, The Oregon Consumer Identity Theft Protection Act places standards for how employers should handle employee medical information. These include implementing server safeguards to protect the confidentiality of a person’s information and reporting data breaches.

What Health Document Privacy Laws do Apply to All Employers?

Even in instances where HIPAA doesn’t apply, employers still have a legal obligation to protect their employee’s health records. The Americans with Disabilities Act and Genetic Information Nondiscrimination Act are two important laws that govern health information and data privacy.


Mon, 21 Nov 2022 18:42:00 -0600 en text/html https://ohsonline.com/articles/2022/11/22/how-hipaa-and-other-health-privacy-laws.aspx
Killexams : causaLens Highlights Security Credentials With HIPAA Compliance and a Clean SOC 2 Report

LONDON--()--causaLens, the UK-based Causal AI pioneer, has confirmed its HIPAA compliance and high levels of overall data security with a clean SOC 2 Type 1 report.

HIPAA, the American Health Insurance Portability and Accountability Act, requires high levels of compliance for data handlers in relation to privacy, security, and breach notification. As healthcare providers and other entities dealing with protected health information move to cloud-based computerised operations, HIPAA compliance has become increasingly important for businesses working with sensitive data on behalf of healthcare organisations.

Developed by the American Institute of Chartered Professional Accountants (AICPA), SOC 2 is an extensive auditing procedure and defines criteria for managing customer data securely and in a manner that protects the organisation as well as the privacy of its customers. SOC 2 is designed for service providers storing customer data in the cloud.

Conducted by the US-based Barr Associates, an internationally recognised CPA firm registered with the US Public Company Accounting Oversight Board, the report affirms that causaLens’ information security practices, policies, procedures, and operations meet the rigorous SOC 2 Trust Service Criteria for security, availability, processing integrity, confidentiality, and privacy.

Darko Matovski, co-founder and CEO of causaLens said: “This is an important milestone for us. HIPAA and SOC 2 compliance help re-confirm the commitments we make to our customers and to the security of their data. causaLens views security as the foundation upon which our products are built and upon which trust with our customers is earned and maintained.

“More enterprises are looking to process sensitive and confidential business data with cloud-based services and it’s critical that they do so in a way that ensures their data will remain safe. Customers carry this responsibility on their shoulders every single day, and it’s important that the vendors they select to process their data in the cloud approach that responsibility in the same way,” he added.

causaLens uses Drata’s automated platform to continuously monitor its internal security controls. These are measured against the highest possible standards giving the business real-time visibility across its whole organisation. Continuous monitoring ensures end-to-end security and enables a systematic approach to compliance and reporting.

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About causaLens

causaLens is the pioneer of Causal AI—a giant leap in machine intelligence.

causaLens builds Causal AI-powered products that are trusted by leading organizations across a wide range of industries. Their flagship product, decisionOS, empowers all types of users to make superior decisions. causaLens is creating a world in which humans leverage trustworthy AI to solve the greatest challenges in the economy, society and healthcare.

About Drata

Drata is the world's most advanced security and compliance automation platform with the mission to help businesses earn and keep the trust of their users, customers, partners, and prospects. For more information, visit drata.com.

Wed, 16 Nov 2022 18:49:00 -0600 en text/html https://www.businesswire.com/news/home/20221117005072/en/causaLens-Highlights-Security-Credentials-With-HIPAA-Compliance-and-a-Clean-SOC-2-Report
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