HIPAA News for Small and Mid-Sized Practices

Is WhatsApp HIPAA Compliant?

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When WhatsApp announced it was introducing end-to-end encryption, it opened up the prospect of healthcare organizations using the platform as an almost free secure messaging app, but is WhatsApp HIPAA compliant?

Many healthcare employees have been asking if WhatsApp is HIPAA compliant, and some healthcare professionals are already using the text messaging app to send protected health information (PHI).

However, while WhatsApp does offer far greater protection than SMS messages and some other text messaging platforms, WhatsApp is NOT HIPAA compliant for several reasons.

Why Isn’t WhatsApp HIPAA Compliant?

First, it is important to point out that no software platform or messaging app can be truly HIPAA compliant, because HIPAA compliance is not about software. It is about users. Software can support HIPAA compliance and incorporate all the necessary safeguards to ensure the confidentiality, integrity, and availability of ePHI, but those controls can easily be undone by users.

HIPAA does not demand that encryption is used. Provided an alternate, equivalent measure is implemented in its place, encryption is not required. Since WhatsApp now includes end-to-end encryption, this aspect of HIPAA is satisfied.

Access controls are also required – See 45 CFR § 164.312(a)(1). This is one area where WhatsApp is not HIPAA compliant. If WhatsApp is installed on a smartphone, anyone with access to that smartphone will be able to view the messages in the user’s WhatsApp account, without the need to enter in any usernames and passwords. That means any ePHI included in conversations would also be accessible. Additional security controls may be installed on a smartphone to authenticate users before the device can be accessed, but even when those controls have been applied, notifications about new messages can often be seen without opening the App or unlocking the device.

HIPAA also requires audit controls – See 45 CFR § 164.312(b). This is another area where WhatsApp is not HIPAA compliant. Messages and attachments are saved, although they can easily be deleted. There is also no HIPAA compliant audit trail maintained in WhatsApp. All data in the account would also need to be backed up. Currently, if you switch phones, your account will be preserved, but your messages will not.

Then there is the issue of what happens to ePHI in a WhatsApp account on a personal device after the user leaves the company. Controls would need to be incorporated to ensure all messages containing ePHI are permanently erased. That would be a logistical nightmare for any covered entity, as it could not be performed remotely, finding messages would be next to impossible, and users would likely object to their WhatsApp being deleted.

Regardless of the features of WhatsApp and how well data is protected in transit, at the time of writing, WhatsApp will not sign a business associate agreement with a HIPAA covered entity. If HIPAA covered entities want to use WhatsApp, before any ePHI is sent, a HIPAA compliant business associate agreement must be signed with WhatsApp. Even though WhatsApp does not read text messages, that does not mean that no business associate agreement would be required.

So, Is WhatsApp HIPAA compliant? In its current form no. When it comes to WhatsApp and HIPAA compliance, even if covered entities were to use additional controls to prevent accidental disclosures, until WhatsApp is willing to sign a BAA, the service cannot be used to send ePHI without violating HIPAA Rules.

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What are the Differences Between a HIPAA Business Associate and HIPAA Covered Entity

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The terms covered entity and business associate are used extensively in HIPAA legislation, but what are the differences between a HIPAA business associate and HIPAA covered entity?

What Are HIPAA Covered Entities?

HIPAA covered entities are healthcare providers, health plans, and healthcare clearinghouses that electronically transmit health information for transactions covered by HHS standards.

Healthcare providers include hospitals and clinics, doctors, dentists, chiropractors, psychologists, pharmacies and nursing homes. Health plans include health insurance companies, company health plans, government programs that pay for healthcare, and HMO’s. Healthcare clearinghouses include transcription service companies that format data to make it compliant and organizations that process non-standard health information.

Even if an entity is a healthcare provider, health plan or healthcare clearinghouse, they are not considered a HIPAA covered entity if they do not transmit any information electronically for transactions that HHS has adopted standards. In such cases, the entity would not be required to comply with HIPAA Rules.

Legally, the HIPAA Privacy Rule only applies to covered entities, although since covered entities usually require the services of vendors, which may need access to PHI in order to perform certain tasks, the HIPAA Privacy Rule permits covered entities to share PHI with those companies.

Before PHI can be shared, vendors must agree to use the PHI only for the tasks that they have been contracted to perform. They must also agree not to disclose the PHI to other entities, and must implement safeguards to ensure the confidentiality, integrity, and availability of PHI. Covered entities must obtain ‘satisfactory assurances,’ in writing, in the form of a contract, that HIPAA Rules will be followed.

What is a HIPAA Business Associate?

A HIPAA business associate is any entity, be that an individual or a company, that is provided with access to protected health information to perform services for a HIPAA covered entity.

Software providers, whose solutions interact with systems that contain ePHI, are considered business associates, as are cloud service providers, cloud platforms, document storage companies (physical and electronic storage), collection agencies, medical billing companies, asset and document recycling companies, answering services, attorneys, actuaries, consultants, medical device manufacturers, transcription companies, CPA firms, third party administrators, medical couriers, and marketing firms. Business associates of covered entities must also comply with HIPAA Rules and can be fined directly by regulators for noncompliance.

Business associates of HIPAA covered entities must sign a contract with the covered entity, termed a business associate agreement or BAA, that outlines the responsibilities of the business associate and explains that the business associate is required to comply with HIPAA Rules.

It is the responsibility of a business associate to ensure that if any subcontractors are used, they too agree to comply with HIPAA Rules and sign a BAA. Information on when a business associate agreement is not required are detailed here.

While a business associate must agree to comply with HIPAA Rules and is responsible for ensuring the confidentiality, integrity, and availability of PHI in its possession, it is the responsibility of a covered entity to ensure that all business associates are complying with HIPAA Rules. If a business associate fails to comply with HIPAA Rules, it is the responsibility of the covered entity to take action to ensure noncompliance is corrected or the contract with the business associate is terminated.

The HHS has developed a tool that explains the differences between a HIPAA business associate and a HIPAA covered entity. You can use the tool to determine if you are a covered entity or a business associate and whether HIPAA Rules must be followed.

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National Cyber Security Awareness Month: What to Expect

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October is National Cyber Security Awareness Month – A month when attention is drawn to the importance of cybersecurity and several initiatives are launched to raise awareness about how critical cybersecurity is to the lives of U.S. citizens.

National Cyber Security Awareness Month is a collaborative effort between the U.S. Department of Homeland Security (DHS), the National Cyber Security Alliance (NCSA) and public/private partners.

Throughout the month of October, the DHS, NCSA, and public and private sector organizations will be conducting events and launching initiatives to raise awareness of the importance of cybersecurity. Best practices will be shared to help U.S. citizens keep themselves safe online and protect their companies, with tips and advice published to help businesses improve their cybersecurity defenses and keep systems and data secure.

DHS and NCSA will focus on a different aspect of cybersecurity each week of National Cyber Security Awareness Month:

National Cyber Security Awareness Month Summary

  • Week 1: Simple Steps to Online Safety (Oct. 2-6)
  • Week 2: Cybersecurity at Work (Oct. 9-13)
  • Week 3: Today’s Predictions for Tomorrow’s Internet (Oct. 16-20)
  • Week 4: Careers in Cybersecurity (Oct. 23-27)
  • Week 5: Cybersecurity and Critical Infrastructure (Oct. 30-31)

Week 1 focuses on basic cybersecurity and cyber hygiene – simple steps that can be taken to greatly improve resilience to cyberattacks.

These basic cybersecurity measures are likely to have already been adopted by the majority of businesses, but these simple controls can all too easily be overlooked. The Department of Health and Human Services’ Office for Civil Rights (OCR) breach portal is littered with reports of security incidents that have resulted from the failures to get the basics of cybersecurity right. Week 1 is the perfect time to conduct a review of these basic cybersecurity measures to ensure they have all been adopted.

This year has already seen several major data breaches reported, including the massive breach at Equifax that impacted 143 million Americans. In May, WannaCry ransomware attacks spread to more than 150 countries and the NotPetya wiper attacks in June causes extensive damage. FedEx and Maersk have both announced that the attacks could end up costing $300 million.

All three of those cyberattacks occurred as a result of the failure to implement patches promptly. Then there is the recently announced Deloitte data breach. That security breach has been linked to the failure to implement two-factor authentication – Another basic cybersecurity measure.

Stop. Think. Connect

During the first week of National Cyber Security Awareness Month, the NCSA will be promoting its “STOP. THINK. CONNECT.” security awareness campaign, which was developed with assistance from the Anti-Phishing Working Group in 2010. The campaign makes available more than 140 online resources that can be used by U.S. citizens to keep themselves secure and by businesses to improve security awareness of the workforce.

Week 2 will focus on cybersecurity in the workplace, highlighting steps that can be taken by businesses to develop a culture of cybersecurity in the workplace. DHS and NCSA will also be encouraging businesses to adopt the National Institute of Standards and Technology Cybersecurity Framework.

Week 3 will focus on protecting personal information in the context of the smart device revolution, highlighting the importance of secure storage, transmission, and handling of data collected by IoT devices.

Week 4 will focus on encouraging students to consider a career in cybersecurity. By 2019, there is expected to be around 2 million unfilled cybersecurity positions in the United States. Advice will be offered about how to switch careers and embark upon a career in cybersecurity.

National Cyber Security Awareness Month finishes with two days of efforts to improve the resiliency of critical infrastructure to cyberattacks.

OCR Encourages HIPAA-Covered Entities to Go Back to Basics

Late last week in its monthly cybersecurity newsletter, OCR sent a reminder to HIPAA-covered entities about the importance of securing health data, saying, “The security of electronic health information is more critical than ever, and it is the responsibility of all in the regulated community to ensure the confidentiality, integrity, and availability of electronic protected health information.” These basic security measures are essential for HIPAA compliance.

OCR suggests HIPAA-covered entities should go back to basics during National Cyber Security Awareness Month and use the tips and advice being issued to ensure all the i’s have been dotted and the t’s crossed.

OCR suggests a good place to start is conducting a review to make sure:

  • Strong passwords have been set – Consisting of passphrases or passwords of at least 10 characters, including lower and upper-case letters, numerals, and special characters.
  • Regular training is provided – To improve phishing awareness, reporting of potential attacks, and covering other important cybersecurity issues.
  • Use multi-factor authentication – So that in the event that a password is obtained or guessed, it will not result in an account being compromised. MFA is strongly recommended for remote access, privileged accounts, and accounts containing sensitive information.
  • Review patch management policies – To ensure that software updates and patches are always applied promptly, on all systems and devices, to fix critical security vulnerabilities.
  • Devices are locked – All devices should be physically secured when they are not in use.
  • Portable device controls are developed – To prohibit the plugging in of personal portable devices into secure computers or networks without first having the devices scanned to make sure they do not contain malware.
  • Policies are developed on reporting threats – Educate the workforce on the importance of reporting potential threats immediately to ensure action can be taken to mitigate risk.

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Is OneDrive HIPAA Compliant?

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Many covered entities want to take advantage of cloud storage services, but can Microsoft OneDrive be used? Is OneDrive HIPAA compliant?

Many healthcare organizations are already using Microsoft Office 365 Business Essentials, including exchange online for email. Office 365 Business Essentials includes OneDrive Online, which is a convenient platform for storing and sharing files.

Microsoft Supports HIPAA-Compliance

There is certainly no problem with HIPAA-covered entities using OneDrive. Microsoft supports HIPAA-compliance and many of its cloud services, including OneDrive, can be used without violating HIPAA Rules.

That said, before OneDrive – or any cloud service – can be used to create, store, or send files containing the electronic protected health information of patients, HIPAA-covered entities must obtain and sign a HIPAA-compliant business associate agreement (BAA).

Microsoft was one of the first cloud service providers to agree to sign a BAA with HIPAA-covered entities, and offers a BAA through the Online Services Terms. The BAA includes OneDrive for Business, as well as Azure, Azure Government, Cloud App Security, Dynamics 365, Office 365, Microsoft Flow, Intune Online Services, PowerApps, Power BI, and Visual Studio Team Services.

Under the terms of its business associate agreement, Microsoft agrees to place limitations on use and disclosure of ePHI, implement safeguards to prevent inappropriate use, report to consumers and provide access to PHI, on request, per the HIPAA Privacy Rule. Microsoft will also ensure that if any subcontractors are used, they will comply with the same – or more stringent – restrictions and conditions with respect to PHI.

Provided the BAA is signed prior to the use of OneDrive for creating, storing, or sharing PHI, the service can be used without violating HIPAA Rules.

Microsoft explains that all appropriate security controls are included in OneDrive, and while HIPAA compliance certification has not been obtained, all of the services and software covered by the BAA have been independently audited for the Microsoft ISO/IEC 27001 certification.

Appropriate security controls are included to satisfy the requirements of the HIPAA Security Rule, including the encryption of data at rest and in transit to HIPAA standards. Microsoft uses 256-bit AES encryption and SSl/TLS connections are established using 2048-bit keys.

There is More to HIPAA Compliance Than Using ‘HIPAA-Compliant’ Services

However, just because Microsoft will sign a BAA, it does not mean OneDrive is HIPAA compliant. There is more to compliance than using a specific software or cloud service. Microsoft supports HIPAA compliance, but HIPAA compliance depends of the actions of users. As Microsoft explains, “Your organization is responsible for ensuring that you have an adequate compliance program and internal processes in place, and that your particular use of Microsoft services aligns with HIPAA and the HITECH Act.”

Prior to the use of any cloud service, a HIPAA-covered entity must conduct a risk analysis and assess the vendor’s provisions and policies. A risk management program must also be developed, using policies, procedures, and technologies to ensure risks are mitigated.

Access policies must be developed and security settings configured correctly. Strong passwords should be used, external file sharing should be disabled, access should be limited to trusted whitelisted networks, and PHI must only be shared with individuals authorized to view the information. When PHI is shared, the minimum necessary standard applies. Logging should be enabled to ensure organizations have visibility into what users are doing with respect to PHI, and when employees no longer require access to OneDrive, such as when they leave the organization, access should be terminated immediately.

So, Is OneDrive HIPAA compliant? Yes and No. OneDrive can be used without violating HIPAA Rules and Microsoft supports HIPAA compliance, but ultimately HIPAA compliance is down to the covered entity, how the service is configured and used.

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Why Dental Offices Should be Worried About HIPAA Compliance

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In 2015, Dr. Joseph Beck became the first dentist to be fined for a HIPAA violation, which sent a warning to dental offices about HIPAA compliance.  Until that point, dental offices had avoided fines for noncompliance with HIPAA Rules.

The penalty was not issued by the Department of Health and Human Services’ Office for Civil Rights (OCR), but by the Office of the Indiana attorney general. The fine of $12,000 was for the alleged mishandling of the protected health information of 5,600 patients.

Since then, many settlements have been reached with covered entities for HIPAA violations. No further penalties have been issued to dental offices, although there is nothing to stop OCR or state attorneys general from fining dental offices for failing to comply with HIPAA Rules and settlements for alleged HIPAA violations are now being reached much more frequently than in 2015. Last year was a record year for settlements and 2017 has continued where 2016 left off.

The probability of HIPAA violations being discovered has also increased. OCR has already commenced the much-delayed second phase of its HIPAA compliance audit program and dental office may still be selected for an audit.

During the first phase of compliance audits in 2011/2012, at least one dental office was audited. That round of audits revealed multiple areas of noncompliance with HIPAA Rules, although OCR chose not to issue any financial penalties. Instead non-compliance was addressed by issuing technical guidance. Now, five years on, covered entities have had plenty of time to implement their compliance programs. Financial settlements can be expected if HIPAA violations are discovered by OCR auditors.

Last year, the threat of HIPAA compliance audits for dental offices prompted Dr. Andrew Brown, chair of the ADA Council on Dental Practice, to issue a stern warning to dental offices on HIPAA compliance, urging them to take HIPAA compliance seriously. Brown said, “There are steep consequences for health care providers that don’t comply with the law and we don’t want to see any dentists having to pay tens of thousands of dollars in a penalty.”

If your dental office has not been selected to demonstrate compliance with HIPAA Rules already, that does not mean an investigation will not be conducted. OCR has only conducted the first round of its phase 2 HIPAA audit program. The second round will involve on-site visits, which are expected to start in early 2018.

OCR also investigates all covered entities that experience a breach of more than 500 records. There has been an increase in cyberattacks on healthcare organizations in recent years, and dental offices can could all too easily come under attack.

Laptop computers containing ePHI can easily be lost or stolen, employees may snoop on records or steal sensitive information, errors can easily be made configuring software, and unaddressed vulnerabilities can easily be exploited. This year, the hacking group TheDarkOverlord exploited a vulnerability and gained access to the records of Aesthetic Dentistry of New York City and stole data – a reportable breach under HIPAA Rules.

If a data breach is experienced, OCR will need to be provided with evidence that HIPAA Rules have been followed. Complaints about privacy violations and other potential HIPAA failures can be submitted via the HHS website, and can easily lead to HIPAA investigations.

It would be a serious error to think that OCR will not investigate small practices. OCR has made it clear that all covered entities, regardless of their size, must comply with HIPAA Rules. It is not only large healthcare organizations that may have to pay a financial penalty for non-compliance with HIPAA Rules, as Dr. Beck could confirm.

The threat of data breaches is greater than ever before and OCR is taking a harder line on healthcare organizations that fail to comply with HIPAA Rules and keep electronic protected health information secure. Dental office should therefore take HIPAA compliance seriously and ensure HIPAA Rules are being followed.

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HITRUST/AMA Launch Initiative to Help Small Healthcare Providers with HIPAA Compliance

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HITRUST has announced it has partnered with the American Medical Association (AMA) for a new initiative that will help small healthcare providers with HIPAA compliance, cybersecurity, and cyber risk management.

Small healthcare providers can be particularly vulnerable to cyberattacks, as they typically lack the resources to devote to cybersecurity and do not tend to have the budgets available to hire skilled cybersecurity staff. This week has underscored the need for small practices to improve their cybersecurity defenses, with the announcement of two cyberattacks on small healthcare providers by the hacking group TheDarkOverlord.

Recent ransomware attacks have also shown that healthcare organizations of all sizes are likely to be attacked. Organizations of all sizes must practice good cyber hygiene and have the right defenses in place to improve resilience against ever changing cyber threats.

HITRUST and AMA will be hosting 2-hour workshops where physicians and other healthcare staff will be educated on key areas of risk management, HIPAA compliance, and cybersecurity, with the workshops specifically focused on small healthcare providers.

The initiative runs alongside HITRUST’s Community Extension Program that was launched earlier this year, with the workshops taking place in the two hours prior to the HITRUST Community Extension Program events, which are taking place in 50 cities across the United States.

HITRUST explained, “Many clinics, physician offices, and other small providers are looking for local, community-based resources to help guide them through the journey of establishing governance and risk management programs to avoid a cyber-related breach or event that would disrupt their organization and expose the confidential information of their patients or members.” One of the aims of the workshops is to make good cyber hygiene manageable for small healthcare providers.

These workshops will provide the information small healthcare providers need to make significant improvements to their cybersecurity posture and help them meet the requirements of the HIPAA Security Rule.

While many topics will be covered in the workshops, they will be primarily focused on teaching the fundamentals of good cyber hygiene, explaining the need for cyber and HIPAA risk assessments, and will cover cost-effective technologies that can be implemented to improve cyber security.

“Trying to determine the best way to secure my practice from cyber threats was a significant – and at times, overwhelming – undertaking,” said Dr. J. Stefan Walker, a practicing physician in a small practice in Corpus Christi, TX. “Many existing cybersecurity resources and education programs are geared toward larger health care organizations and are not practical for a practice with only a handful of employees.” These workshops will help small healthcare organizations by providing relevant, useful, and practical advice specific to practices of their size.

The first workshop is being hosted by Children’s Health in Dallas, TX and will take place on October 9. Details of further events will be posted on the HITRUST website.

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HHS Issues Partial HIPAA Privacy Rule Waiver in Hurricane Maria Disaster Zone

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The U.S. Department of Health and Human Services has already issued two partial waivers of HIPAA sanctions and penalties in areas affected by hurricanes this year. Now a third HIPAA waiver has been issued, this time in the Hurricane Maria disaster area in Puerto Rico and the U.S. Virgin Islands.

As was the case with the waivers issued in relation to Hurricane Harvey and Hurricane Irma, the waiver only applies to covered entities in areas where a public health emergency has been declared, only for 72 hours following the implementation of the hospital’s disaster protocol, and only for specific provisions of the HIPAA Privacy Rule:

  • The requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
  • The requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
  • The requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
  • The patient’s right to request privacy restrictions. See 45 CFR 164.522(a).
  • The patient’s right to request confidential communications. See 45 CFR 164.522(b)

As soon as the 72-hour period has elapsed, or as soon as the Presidential or Secretarial declaration terminates, the waiver ceases to apply and covered entities must comply with the above provisions of the Privacy Rule for all patients still under their care.

Further information on the HIPAA waiver in relation to Hurricane Maria can be viewed here.

In an emergency situation, a waiver of sanctions and penalties for violations of limited provisions of the HIPAA Privacy Rule is not strictly necessary, although such a waiver does offer some reassurance to covered entities that are operating in a disaster area.

The HHS has pointed out in its recent communication that in emergency situations, covered entities are permitted to share limited protected health information of patients even if a waiver has not been issued, when it is in the best interests of patients to do so, to help identify patients, to help locate family members, and for public health activities. In the case of the latter, it is permissible to share PHI with public health authorities such as a state or local health department or the CDC for the purpose of preventing or controlling disease, injury or disability.

PHI can also be shared for the purposes of treatment, either the treatment of the patient or another person who may be affected by the same situation, as well as to help with the coordination or management of healthcare, such as sharing PHI with other healthcare providers or when referring patients for treatment – 45 CFR §§ 164.502(a)(1)(ii), 164.506(c)

PHI can be shared with anyone, as necessary, to prevent or lessen a serious or imminent threat to the health and safety of a person or the public., if that person is in a position to lessen or prevent the threatened harm. Such disclosures can be made without the patient’s permission. It is left to the discretion of the covered entity to make a determination about the nature and severity of the threat to health – 45 CFR 164.512(j).

Disclosures can be made to family, friends, and other individuals involved in a patient’s care, and information can be shared to help identify, locate, and notify family members, guardians, or others responsible for a patient’s care – 45 CFR 164.510(b).

When others not involved in the treatment of a patient, including the media, request information about a specific patient by name, a HIPAA-covered entity is permitted to disclose “limited facility directory information” and provide general information about the patient such as whether they are in critical or stable condition, are deceased, or have been treated and have left the facility, provided the patient has not requested the information be kept private.

In all cases, any disclosures must be limited to the minimum necessary information to achieve the purpose for which the information is disclosed. At all times, even in emergency situations, the HIPAA Security Rule requirements apply and covered entities must continue to ensure administrative, physical, and technical safeguards are in place to preserve the confidentiality, integrity, and availability of PHI.

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OCR Launches Information is Powerful Medicine Campaign to Encourage Patients to Access Their Health Data

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The Department of Health and Human Services’ Office for Civil Rights has launched a new campaign to raise awareness of patients’ right to access their health information and the benefits of doing so.

The “Information is Powerful Medicine” campaign informs patients that they have the right to obtain copies of their health data and tells them to “Get it. Check it. Use it.”

The benefits to patients are clear. If they obtain copies of the health information they can check their medical records for errors and correct any mistakes. Having access to health data helps patients to make better decisions about their health care and discuss their health more fully with their providers. Armed with their health data, patients can do more to stay healthy.

Patients are advised that the HIPAA Privacy Rule allows them to obtain a physical or electronic copy of their health data and that their provider should provide the information as requested within 30 days. It has been explained that they may be charged a nominal fee for obtaining a copy of their health data. Patients are also informed that copies of their health data cannot be denied by their providers, even if there is a medical bill outstanding.

Healthcare providers should encourage their patients to take greater interest in their own healthcare and obtain copies of their health records. OCR has produced a range of resources for healthcare providers to use to achieve this aim, including brochures, web banners, and posters.

The OCR resources can be accessed on this link: HIPAA Right to Access Health Information.

Healthcare providers should make it as easy as possible for patients to request copies of their health data. To make the process as easy as possible, consider using the model PHI request form developed by AHIMA. The form helps healthcare providers streamline the request process and ensure all necessary information is obtained from patients.

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Limited HIPAA Waiver Granted to Hospitals in Irma Disaster Zone

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A public health emergency has been declared in areas of the U.S. Virgin Islands, Puerto Rico, and Florida affected by Hurricane Irma.

As was the case in Texas and Louisiana after Hurricane Harvey, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has announced a limited waiver of HIPAA Privacy Rule sanctions and penalties for hospitals affected by Irma.

OCR has stressed that the HIPAA Privacy and Security Rules have not been suspended and covered entities must continue to follow HIPAA Rules; however, certain provisions of the Privacy Rule have been waived under the Project Bioshield Act of 2014 and Section 1135(b) of the Social Security Act.

In the event that a hospital in the disaster zone does not comply with the following aspects of the HIPAA Privacy Rule, penalties and sanctions will be waived:

  • 45 CFR 164.510(b) – Obtain a patient’s agreement to speak with family members or friends involved in the patient’s care
  • 45 CFR 164.510(a) – Honor requests to opt out of the facility directory.
  • 45 CFR 164.520 – Distribute a notice of privacy practices.
  • 45 CFR 164.522(a) – The patient’s right to request privacy restrictions.
  • 45 CFR 164.522(b) – The patient’s right to request confidential communications.

The waiver only applies to penalties and sanctions in relation to the above provisions of the HIPAA Privacy Rule, only to hospitals in the emergency area that have implemented their disaster protocol, and only for the time period identified in the public health emergency declaration.

The waiver applies for a maximum of 72 hours after a hospital has implemented its disaster protocol. If either the President’s or HHS Secretary’s declaration terminates within that 72-hour time period, the hospital must immediately comply with all aspects of the HIPAA Privacy Rule for all patients under its care.

In emergency situations, the HIPAA Privacy Rule does permit the sharing of PHI for treatment purposes and with public health authorities that require access to PHI to carry out their public health mission. HIPAA-covered entities are also permitted to share information with family, friends, and others involved in an individual’s care, even if a waiver has not been issued. Further details of the allowable disclosures in emergency situations are detailed in the HHS HIPAA bulletin.

In all cases, covered entities must limit disclosures to the minimum necessary information to achieve the purpose for which PHI is disclosed.

Even during natural disasters, healthcare organizations and their business associates must continue to comply with the HIPAA Security Rule and must ensure appropriate administrative, physical, and technical safeguards are maintained to ensure the confidentiality, integrity, and availability of electronic protected health information to prevent unauthorized access and disclosures.

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