HIPAA News for Small and Mid-Sized Practices

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

Posted by HIPAA Journal

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

Posted by HIPAA Journal

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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Warning Issued About Vulnerabilities in Smiths Medical Medfusion 4000 Devices

Posted by HIPAA Journal

The U.S. Department of Homeland Security (DHS) has issued a warning about vulnerabilities in Smiths Medical Medfusion 4000 wireless syringe infusion pumps. The vulnerabilities could potentially be exploited by hackers to alter the performance of the devices.

Smiths Medical Medfusion 4000 devices are used to deliver small doses of medication and are used throughout the United States and around the world in acute care settings. Eight vulnerabilities have been identified in three versions of the wireless syringe infusion pumps (V1.1, v1.5 and v1.6), with CVSS v3 scores ranging from 3.7 to 8.1. The vulnerabilities could be exploited remotely, potentially causing harm to patients. Hackers could also exploit the vulnerabilities to gain access to other healthcare IT systems if the devices are not segmented on the network.

DHS says the impact to organizations depends on several factors, based on specific clinical usage and hospital’s operational environments. Six of the vulnerabilities relate to hard-coded passwords/credentials, certificate validation issues, and authentication gaps which could allow hackers to gain access to the devices. The other two vulnerabilities involve third-party components, although those vulnerabilities would be much harder to exploit.

Smiths Medical has reassured healthcare organizations that while the vulnerabilities could potentially be exploited, in a clinical setting this would be highly unlikely, explaining the exploit “requires a complex and an unlikely series of conditions.” Attackers would also require a high skill level to exploit the vulnerabilities in Smiths Medical Medfusion 4000 wireless syringe infusion pumps. ICS-CERT says there are no publicly known exploits targeting the vulnerabilities.

Smiths Medical has been working closely with DHS and will resolve the flaws, although the Plymouth, MN-based medical device manufacturer will not do so until the release of Medfusion 4000 v1.6.1 in January 2018.

In the meantime, healthcare organizations using vulnerable versions of the devices have been advised by Smiths Medical to take steps to reduce risk. Those steps include:

  • Assigning static IP addresses to the infusing pumps
  • Monitoring network activity for rogue DNS and DHCP servers
  • Ensuring network segments are installed and the devices are segregated from other parts of hospital networks. Hospitals have been advised to consider network micro segregation
  • Using network virtual local area networks (VLANs) for the segmentation
  • Adopting password best practices, such as setting strong passwords and not re-using passwords
  • Performing routine backups and evaluations.

ICS-CERT recommends disconnecting the devices from the network until the product fix is applied, although this would require the drug library to be updated manually on all devices.

ICS-CERT also recommends:

  • Closing Port 20/FTP, Port 21/FTP, and Port 23/Telnet if the devices need to be networked
  • Disabling the FTP server on the pumps
  • Closing all unused ports
  • Monitoring and logging all network traffic attempting to reach the affected products, including attempts on closed ports
  • Locating the devices behind firewalls
  • Using VPNs to connect to the devices if remote access is required, and to ensure the latest version of VPNs are installed.

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OCR Stresses Need for Covered Entities to Prepare for Hurricanes and Other Natural Disasters

Posted by HIPAA Journal

Hospitals in Texas and Louisiana had to ensure medical services continued to be provided during and after Hurricane Harvey, without violating HIPAA Rules. Questions were raised about when it is permitted to share health information with patients’ friends and family, the media and the emergency services and how the Privacy Rule applies in emergencies. The Department of Health and Human Services’ Office for Civil Rights responded by issuing guidance to covered entities on the HIPAA Privacy Rule and disclosures of patient health information in emergency situations to help healthcare organizations protect patient privacy and avoid violating HIPAA Rules. Allowable disclosures are summarized in this document.

Hot on the heels of hurricane Harvey comes hurricane Irma, closely followed by hurricane Jose. Hospitals in other parts of the United States will have to cope with the storm and its aftermath and still comply with HIPAA Rules. OCR has taken the opportunity to remind covered entities of the need to prepare.

OCR has explained that the HIPAA Privacy Rule was carefully created to ensure that in emergency situations, healthcare organizations can protect the privacy of patients and still share individually identifiable health information.

OCR also reconfirmed that even in emergency situations, the HIPAA Security Rule is not suspended and preparation for emergencies is essential. HIPAA-covered entities and business associates are required to implement strategies to ensure ePHI remains secured at all times and the confidentiality, integrity, and availability of ePHI is not placed in jeopardy. During and after an emergency, ePHI must be accessible, which means covered entities must plan for all eventualities to ensure patient health information can always be accessed.

OCR explained that the HIPAA Security Rule – § 164.308(a)(7) – requires contingency plans to include a data backup plan, disaster recovery plan, and emergency mode operation plan. These are all required elements of the HIPAA Security Rule.

The data backup plan must ensure retrievable, exact copies of electronic protected health information are created and maintained. The disaster recovery plan must ensure any data lost during a natural disaster or emergency can be recovered from backups. Procedures must be established, and implemented as necessary, to ensure data can be quickly recovered. During emergency mode, security processes to protect ePHI must be maintained, even during power outages and technical failures.

Further, there are two addressable requirements: testing and revision procedures and application and data criticality analysis. Covered entities should periodically test their contingency plans and revise them as necessary to ensure they continue to be effective in an emergency situation. Covered entities should also identify software applications that store, maintain or transmit ePHI, and assess how important each is to business needs. Priorities must be set for data backup, emergency operations, and disaster recovery.

OCR has drawn attention to an interactive decision tool on the HHS website that has been developed to help healthcare organizations prepare for the worst and find out how HIPAA Rules apply in emergency situations. OCR explains, “The tool is designed for covered entities as well as emergency preparedness and recovery planners at the local, state and federal levels.”

While the reminders have been issued specifically to help covered entities prepare for when hurricane Irma makes landfall, even covered entities unlikely to be affected must ensure they are prepared for the worst.

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OCR Head Expects Major HIPAA Settlement for a Big, Juicy, Egregious Breach in 2017

Posted by HIPAA Journal

Roger Severino, the Director of the Department of Health and Human Services’ Office for Civil Rights (OCR) has stated his main enforcement priority for 2017 is to find a “big, juicy, egregious” HIPAA breach and to use it as an example for other healthcare organizations of the dangers of failing to follow HIPAA Rules.

When deciding on which cases to pursue, OCR considers the opportunity to use the case as an educational tool to remind covered entities of the need to comply with specific aspects of HIPAA Rules.

At the recent ‘Safeguarding Health Information’ conference run by OCR and NIST, Severino explained that “I have to balance that law enforcement instinct with the educational component that we do.” Severino went on to say, “I really want to make sure people come into compliance without us having to enforce. I want to underscore that.”

Severino did not explain what aspect of noncompliance with HIPAA Rules OCR is hoping to highlight with its next big, juicy settlement, although no healthcare organization is immune to a HIPAA penalty if they are found to have violated HIPAA Rules. Severino said, “Just because you are small doesn’t mean we’re not looking and that you are safe if you are violating the law. You won’t be.”

Severino also explained that the number of complaints OCR is now receiving is colossal. More than 20,000 complaints about security incidents and privacy violations are received each year. OCR has many staff issuing technical assistance to help covered entities with their compliance programs.  The goal is to significantly reduce the number of complaints and enjoy a “culture of compliance” throughout the country.

The majority of HIPAA violations are resolved through technical assistance and voluntary compliance, but financial penalties are appropriate for egregious breaches of HIPAA Rules.

Already this year, OCR has agreed eight settlements with covered entities to resolve HIPAA violations discovered during investigations of complaints and data breaches and has issued one civil monetary penalty:

2017 HIPAA Enforcement Actions

  • Memorial Healthcare System – $5.5 million
  • Children’s Medical Center of Dallas- $3.2 million (Civil monetary penalty)
  • Cardionet – $2.5 million
  • Memorial Hermann Health System (MHHS) – $2.4 million
  • MAPFRE Life Insurance Company of Puerto Rico – $2.2 million
  • Presense Health – $475,000
  • Metro Community Provider Network – $400,000
  • Luke’s-Roosevelt Hospital Center Inc. – $387,000
  • The Center for Children’s Digestive Health – $31,000

The largest HIPAA settlement of 2017 was agreed with Memorial Healthcare System – a health system consisting of 6 hospitals and various other facilities in South Florida. The settlement of $5.5 million resolved potential violations of HIPAA Rules relating to the impermissible accessing of ePHI by employees and the impermissible disclosure of PHI to affiliated physician office staff.  The settlement underscored the importance of audit controls and the need to carefully control who has access to the ePHI.

The second largest HIPAA settlement of 2017 was for $2.5 million and resolved multiple potential violations of HIPAA Rules that contributed to a breach of 1,391 patient records. The incident involved the theft of an unencrypted laptop computer from healthcare services provider Cardionet. The settlement underscored the importance of conducting a comprehensive risk assessment and of addressing vulnerabilities to the confidentiality of ePHI.

In May, OCR announced a $2.4 million settlement with Memorial Hermann Health System. The settlement resolved HIPAA violations discovered during the investigation of an impermissible disclosure of a patient’s ePHI in a press release and during subsequent meetings with advocacy groups and state representatives.

In January, a $2.2 million settlement was agreed with MAPFRE Life Insurance Company of Puerto Rico. The incident that triggered the investigation involved the theft of an unencrypted pen drive containing the PHI of 2,209 individuals. The investigation revealed multiple violations of HIPAA Rules including the failure to conduct a thorough and accurate risk assessment, the failure to implement a security awareness training program, the failure to encrypt ePHI and the failure to implement appropriate policies to safeguard ePHI.

The civil monetary penalty against Children’s Medical Center of Dallas was issued for the impermissible disclosure of ePHI and multiple failures to comply with the HIPAA Security Rule over several years. The settlement resolves HIPAA failures that contributed to a breach of 3,800 records involving the loss of an unencrypted Blackberry device in 2009 and the loss of an unencrypted laptop containing 2,462 records in 2013.

There has been a period of quiet on the enforcement front over the summer, with the last settlement announced in May. The fall is likely to see more settlements announced and this year looks on track to be another record year for HIPAA enforcement. The big, juicy egregious breach that OCR is looking for may prove to be the largest HIPAA penalty yet.

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HHS Issues Partial Waiver of Sanctions and Penalties for Privacy Rule Violations in Hurricane Harvey Disaster Zone

Posted by HIPAA Journal

During emergencies such as natural disasters, complying with all HIPAA Privacy Rule provisions can be a challenge for hospitals and can potentially have a negative impact on patient care and disaster relief efforts.

In emergency situations, HIPAA Rules still apply. The HIPAA Privacy Rule allows patient information to be shared to help with disaster relief efforts and ensure patients get the care they need.

The Privacy Rule permits covered entities to share patient information for treatment purposes, for public health activities, to disclose patient information to family, friends and others involved in a patient’s care, to prevent or lessen a serious and imminent threat to the health and safety of a person or the public and, under certain circumstances, allows covered entities to share limited information with the media and other individuals not involved in a patient’s care (45 CFR 164.510(a)).

In such cases, any disclosures must be limited to the minimum necessary information to accomplish the purpose for which the information is being disclosed.

However, disasters often call for a relaxation of HIPAA Rules and the Secretary of the Department of Health and Human may choose to waive certain provisions of the HIPAA Privacy Rule under Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act.

During the Ebola crisis in November 2014, OCR issued a waiver for certain requirements of HIPAA Rules, as was the case in the immediate aftermath of Hurricane Katrina when a waiver was issued for certain Privacy Rule provisions.

Yesterday, HHS Secretary Tom Price announced that OCR will waive sanctions and financial penalties for specific Privacy Rule violations against hospitals in Texas and Louisiana that are in the Hurricane Harvey disaster area.

The waiver only applies to the provisions of the HIPAA Privacy Rule as detailed below:

  • 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)

These waivers only apply to hospitals in the emergency areas that have been identified in the public health emergency declaration.

The waiver only applies if hospitals have instituted a disaster protocol and the waiver applies for 72 hours after the disaster protocol has been implemented. The waiver will also only apply until the Presidential or Secretarial declaration terminates, even if the 72 hours has not elapsed.

Further information on the limited waiver of HIPAA sanctions and penalties as a result of Hurricane Harvey can be viewed in this HIPAA bulletin from HHS.

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HHS Issues Partial Waiver of Sanctions and Penalties for Privacy Rule Violations in Hurricane Harvey Disaster Zone

Posted by HIPAA Journal

During emergencies such as natural disasters, complying with all HIPAA Privacy Rule provisions can be a challenge for hospitals and can potentially have a negative impact on patient care and disaster relief efforts.

In emergency situations, HIPAA Rules still apply. The HIPAA Privacy Rule allows patient information to be shared to help with disaster relief efforts and ensure patients get the care they need.

The Privacy Rule permits covered entities to share patient information for treatment purposes, for public health activities, to disclose patient information to family, friends and others involved in a patient’s care, to prevent or lessen a serious and imminent threat to the health and safety of a person or the public and, under certain circumstances, allows covered entities to share limited information with the media and other individuals not involved in a patient’s care (45 CFR 164.510(a)).

In such cases, any disclosures must be limited to the minimum necessary information to accomplish the purpose for which the information is being disclosed.

However, disasters often call for a relaxation of HIPAA Rules and the Secretary of the Department of Health and Human may choose to waive certain provisions of the HIPAA Privacy Rule under Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act.

During the Ebola crisis in November 2014, OCR issued a waiver for certain requirements of HIPAA Rules, as was the case in the immediate aftermath of Hurricane Katrina when a waiver was issued for certain Privacy Rule provisions.

Yesterday, HHS Secretary Tom Price announced that OCR will waive sanctions and financial penalties for specific Privacy Rule violations against hospitals in Texas and Louisiana that are in the Hurricane Harvey disaster area.

The waiver only applies to the provisions of the HIPAA Privacy Rule as detailed below:

  • 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)

These waivers only apply to hospitals in the emergency areas that have been identified in the public health emergency declaration.

The waiver only applies if hospitals have instituted a disaster protocol and the waiver applies for 72 hours after the disaster protocol has been implemented. The waiver will also only apply until the Presidential or Secretarial declaration terminates, even if the 72 hours has not elapsed.

Further information on the limited waiver of HIPAA sanctions and penalties as a result of Hurricane Harvey can be viewed in this HIPAA bulletin from HHS.

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FDA Announces Voluntary Recall of St. Jude Medical Implantable Cardiac Pacemakers

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The U.S. Food and Drug Administration (FDA) is recommending all patients with vulnerable St. Jude Medical implantable cardiac pacemakers visit their providers to have the firmware on their devices updated. The update will make the devices more resilient to cyberattacks.

Last year, MedSec Holdings passed on the findings of a study of cybersecurity vulnerabilities in St. Jude Medical devices to the short-selling firm Muddy Waters Capital. The report identified a number of vulnerabilities that could be exploited to alter the functioning of the devices and drain batteries prematurely.

While St. Jude Medical initially denied the vulnerabilities existed, the FDA investigated the claims and confirmed that remotely exploitable vulnerabilities were present in certain St. Jude Medical Products.

Now, a year after the vulnerabilities were disclosed, the FDA has announced a voluntary recall of the devices to update the firmware to prevent the devices from being hacked via radio frequency communications.

There are between 450,000 and 500,000 vulnerable devices currently in use in the United States and a recall of this scale will almost certainly cause problems for healthcare providers. The FDA and Abbot Laboratories, which acquired St. Jude Medical last year, have suggested patients have the firmware upgrade applied at their next scheduled visit to their healthcare provider rather than make a separate visit.

The recall does not apply to implantable cardiac defibrillators or cardiac resynchronization ICDs, only to the following St. Jude Medical pacemakers:

  • Accent SR RF™
  • Accent MRI™
  • Assurity™
  • Assurity MRI™
  • Accent DR RF™
  • Anthem RF™
  • Allure RF™
  • Allure Quadra RF™
  • Quadra Allure MP RF™

The update will require any device attempting to communicate with the implanted pacemaker to be authenticated via the Merlin Programmer and Merlin@home Transmitter. All Abbott Laboratories devices manufactured after August 28, 2017 will include the updated firmware. The firmware update was released on August 29.

The FDA has not recommended devices be removed and replaced as the firmware update will make the devices secure. The update is a quick and simple process that takes just three minutes, although patients will be required to visit their providers to have the update applied. The update cannot be issued remotely as there is “a low risk [<0.023%] of update malfunction”.  During the update, the device will continue to function in backup mode and life-saving functionality will be maintained. The devices will return to normal settings after the update has been applied.

It has been more than a year since the report of the vulnerabilities was published, although during that time there have been no reported attacks or harm caused to patients. The Department of Homeland Security says exploiting the vulnerabilities would require “a highly complex set of circumstances.”

“All industries need to be constantly vigilant against unauthorized access,” said Robert Ford, executive vice president, Medical Devices at Abbot Laboratories. He explained, “[cybersecurity] isn’t a static process, which is why we’re working with others in the healthcare sector to ensure we’re proactively addressing common topics to further advance the security of devices and systems.”

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FDA Announces Voluntary Recall of St. Jude Medical Implantable Cardiac Pacemakers

Posted by HIPAA Journal

The U.S. Food and Drug Administration (FDA) is recommending all patients with vulnerable St. Jude Medical implantable cardiac pacemakers visit their providers to have the firmware on their devices updated. The update will make the devices more resilient to cyberattacks.

Last year, MedSec Holdings passed on the findings of a study of cybersecurity vulnerabilities in St. Jude Medical devices to the short-selling firm Muddy Waters Capital. The report identified a number of vulnerabilities that could be exploited to alter the functioning of the devices and drain batteries prematurely.

While St. Jude Medical initially denied the vulnerabilities existed, the FDA investigated the claims and confirmed that remotely exploitable vulnerabilities were present in certain St. Jude Medical Products.

Now, a year after the vulnerabilities were disclosed, the FDA has announced a voluntary recall of the devices to update the firmware to prevent the devices from being hacked via radio frequency communications.

There are between 450,000 and 500,000 vulnerable devices currently in use in the United States and a recall of this scale will almost certainly cause problems for healthcare providers. The FDA and Abbot Laboratories, which acquired St. Jude Medical last year, have suggested patients have the firmware upgrade applied at their next scheduled visit to their healthcare provider rather than make a separate visit.

The recall does not apply to implantable cardiac defibrillators or cardiac resynchronization ICDs, only to the following St. Jude Medical pacemakers:

  • Accent SR RF™
  • Accent MRI™
  • Assurity™
  • Assurity MRI™
  • Accent DR RF™
  • Anthem RF™
  • Allure RF™
  • Allure Quadra RF™
  • Quadra Allure MP RF™

The update will require any device attempting to communicate with the implanted pacemaker to be authenticated via the Merlin Programmer and Merlin@home Transmitter. All Abbott Laboratories devices manufactured after August 28, 2017 will include the updated firmware. The firmware update was released on August 29.

The FDA has not recommended devices be removed and replaced as the firmware update will make the devices secure. The update is a quick and simple process that takes just three minutes, although patients will be required to visit their providers to have the update applied. The update cannot be issued remotely as there is “a low risk [<0.023%] of update malfunction”.  During the update, the device will continue to function in backup mode and life-saving functionality will be maintained. The devices will return to normal settings after the update has been applied.

It has been more than a year since the report of the vulnerabilities was published, although during that time there have been no reported attacks or harm caused to patients. The Department of Homeland Security says exploiting the vulnerabilities would require “a highly complex set of circumstances.”

“All industries need to be constantly vigilant against unauthorized access,” said Robert Ford, executive vice president, Medical Devices at Abbot Laboratories. He explained, “[cybersecurity] isn’t a static process, which is why we’re working with others in the healthcare sector to ensure we’re proactively addressing common topics to further advance the security of devices and systems.”

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