Guidance For Contacting COVID-19 Patients Concerning Blood and Plasma Donations

Whenever patients get an infectious respiratory disease like COVID-19, the immune system produces antibodies that give protection to the body when the pathogen is contracted again. The antibodies found in the blood of patients who get healed from this kind of sickness are invaluable, because they not only give protection to the patient, but that protection can be transmitted to other patients as well.

Two preparations can be made from the donation of plasma and blood: hyperimmune immunoglobulin and convalescent plasma. Hyperimmune immunoglobulin and convalescent plasma were both used to effectively treat patients who got other viral respiratory illnesses. Considering the severeness of COVID-19 and the high fatality rate, these therapies can be important for patients who are finding it hard to combat the illness. Research studies are currently ongoing to test if antibody treatments are potent against COVID-19.

To take part in these programs, previously diagnosed COVID-19 patients must be contacted and questioned if they would like to donate their blood and plasma. However, does the HIPAA Privacy Rule permit this contact?

On June 12, 2020, the Department of Health and Human Services’ Office for Civil Rights published guidance for healthcare organizations regarding the HIPAA Privacy Rule and the permission to get in touch with COVID-19 patients to ask for blood and plasma donations.

According to OCR, the HIPAA Privacy Rule doesn’t stop healthcare organizations from getting in touch with COVID-19 patients to ask for blood and plasma donations and there is no need to ask for prior consent from the patient.

Healthcare organizations can get in touch with patients to tell them about the options to donate blood and plasma to help in the COVID-19 response to boost the chances of other patents to fight the disease.

HIPAA covered entities and business associates responding on their behalf could use or share PHI for reasons of treatment, medical operations, and payment without the need to get patient authorization first. Asking for a blood or plasma donation doesn’t fall under the classification of a treatment since the blood/plasma is not going to be used for patient treatment, rather it is being employed for population-based medical care operations to better health, case supervision, and coordination of care, which are listed in the meaning of healthcare operations.

Certain misunderstandings regarding the contacting of patients to request blood donations would make up marketing communications, which are typically not allowed by the HIPAA Privacy Rule without getting patient authorization first.

In this instance, there is an exception to the Privacy Rule’s Marketing provision as per the OCR guidance. A covered health care entity is allowed to communicate regarding the covered entity’s population-based case supervision and associated medical care operations activities, so long as the covered entity does not get direct or indirect payment from, or for the third party whose service is referred to in the communication (for example, a blood and plasma donation center).

Patient authorization is necessary before disclosing PHI to a third party, like a blood and plasma donation center, to permit contact of a COVID-19 patient to ask for blood and plasma donations on behalf of the donation center’s own needs.

H-ISAC Publishes Framework for Managing Identity in Healthcare

The Health Information Sharing and Analysis Center (H-ISAC) issued a framework for CISOs to handle identity and protect their company against identity-centric cyberattacks. This second white paper published by H-ISAC covers the identity-centric solution to security. The first white paper talks about why an identity-centric strategy to cybersecurity is needed today, with the new white paper explaining how to implement that approach.

By implementing the framework, CISOs can manage the entire identity lifecycle of patients, practitioners, employees, and business partners in a way that guards against identity cyberattacks, reduces risk and improves operational efficiencies.

The framework was created for CISOs at healthcare companies of varying sizes. Consequently, it does not provide a one-size-fits-all model. Instead, parts of the framework may be used in a different way according to various conditions and use cases. CISOs have to evaluate the resources available and their special risks and make a decision on how best to utilize the framework.

The framework highlights the diverse elements that are needed in a modern identity-based approach to cybersecurity and shows how those elements incorporate and inter-relate to protect the enterprise.

The framework’s central idea is simple. How to enable users to access resources with security against cyberattacks. The primary focus of the framework is identity governance and administration system, which works as the central nervous system that connects in all the other elements and makes certain they work easily together.

The identity governance and administration system enable organizations to put in place set regulations and processes associated to the development, removal, and update of accounts, take care of policies and processes of all areas of their identity and access management (IAM) system, handle privilege escalation requests, perform audits for compliance purposes, and remediate any improper use of the IAM system.

The framework makes use of identity directories as an authoritative identity store for a firm, which explains roles, accounts, attributes, and the privileges connected with various roles and accounts. The white paper points out three guiding concepts for authorization:

  • Granting privileges – Privileges should be securely controlled and assigned according to roles, rights, and duties
  • Managing privileges – Processes need to be specified to manage privileges and update them with changing conditions
  • Reviewing privileges – Reviews must also be performed to make sure that users were assigned rights that are applicable for their role and accountabilities.

A couple of years ago, access to resources only requires a password, but threat actors today are skilled at stealing passwords and consequently, the security utility of passwords has declined. H-ISAC hence recommends using multi-factor authentication. The framework improves upon MFA and endorses

  • Device authentication, which ensures only trusted devices get access to resources
  • Human authentication, which makes sure that the authorized person is using that device
  • Privileged access management, which is used for session tracking and to employ more levels of authentication to avert credential compromise and restrict privilege escalation
  • Analytics, which is used to determine anomalies that can suggest attempts by unauthorized persons to get access resources, for instance using a device to access resources from California and then from New York five minutes later

The framework additionally specifies four use cases:

  1. Managing users and modifying privileges once an employee switches role
  2. On-boarding new employees
  3. Credentialing new patients
  4. Credentialing a third-party business partner for minimal systems access

Guidance on Managing the Cybersecurity Tactical Response in a Pandemic

The Healthcare and Public Health Sector Coordinating Council (HSCC) and the Health Information Sharing and Analysis Center (H-ISAC) issued a joint guidance on managing the cybersecurity tactical response when facing emergency cases, for instance, a pandemic.

Threat actors will attempt to exploit emergency scenarios to carry out attacks, which was plainly the case at this time of the COVID-19 pandemic. In a lot of instances, the length of an emergency will restrict the possibility for threat actors to exploit, but during a pandemic the time frame of exposure is longer. The SARS-CoV-2 outbreak was announced on January 30, 2020 as a public health emergency, providing threat actors sufficient time to take advantage of COVID-19 to perform attacks on the healthcare sector.

The important element to handling the greater level of cybersecurity risk at the time of emergency cases is preparation. Without preparation, healthcare institutions will be continuously fighting fires and rushing to enhance security at the moment when resources are stretched thin.

The recent guidance was produced during the COVID-19 pandemic by H-ISAC, HSCC’s Cybersecurity Working Group (CWG), the healthcare industry and government cybersecurity specialists and is meant to assist healthcare organizations to create a tactical response for handling cybersecurity threats that arise during emergencies and to assist them to improve their degree of preparedness.

During the COVID-19 crisis, cyber threat actors have carried out a variety of attacks on healthcare companies which include phishing attacks, domain attacks, and ransomware and malware attacks. The attacks happen at a time when healthcare institutions were trying to give patient care for highly infectious patients, set up remote diagnostic and treatment services, and switch to teleworking to avoid the spread of COVID-19. The modification in working routines substantially amplified the attack surface and launched new vulnerabilities and attack vectors.

The vulnerability to malicious cyber-actors increases for each gain provided by automation, interoperability, and data analytics. To curb these attacks prior to they happen, it is important for healthcare companies to establish, employ, and maintain present and effective cybersecurity procedures.

Healthcare organizations of all sizes could use the guidance document to enhance their cybersecurity programs and get ready for emergency scenarios. Smaller healthcare providers may use the guidance for choosing appropriate measures to enhance their security posture, while bigger organizations that have already prepared their tactical crisis response may make use of the guide as a checklist to make sure nothing is overlooked.

The guidance document places tactics, practices, and activities into four major categories:

  • Education and Outreach
  • Enhance Prevention Techniques
  • Enhance Detection and Response
  • Take Care of the Team

The cybersecurity response to an emergency is mostly based on technical settings, however, HSCC/H-ISAC makes clear that education and outreach have an essential role in the response strategy’s success. In emergency circumstances, even the perfectly laid plans may come unstuck with no appropriate education and outreach. Organizations that communicate their plans efficiently will minimize misunderstandings, boost response times, and increase the efficiency of their cybersecurity plan. The guide details how to create a communication plan and perform policy and procedure assessments properly.

Stopping cyberattacks is crucial. The majority of healthcare companies will have put in place a variety of measures to combat cyberattacks before the public health emergency, however HSCC/H-ISAC advocates three practices that ought to be assessed: Restricting the likely attack surface, strengthening remote access, and using threat intelligence feeds.

Restricting the attack surface calls for efficient vulnerability management, quick patching, protecting medical devices and endpoints, and regulating third-party network access. The guidance document advises a few of the means of protecting remote access, and how to take advantage of threat intelligence feeds to avoid attacks and speed up the response.

A lot of attacks are hard to prevent, therefore it is crucial for systems to be created and executed to identify successful attacks and react immediately. The guidance document recommends several steps to improve detection and reaction to attacks.

It is additionally essential to manage the team. In desperate circumstances, health, safety, work security, and financial steadiness are all important issues for healthcare workers. It is essential for companies to communicate properly with their employees and deal with these concerns and talk about how the company will help employees throughout the crisis.

The guidance document can be viewed on this link. HSCC introduced a second guidance document earlier this month that features steps healthcare companies can take on to safeguard trade secrets and research. The guidance document can be downloaded here.

Send FTC Your Comments on the Health Breach Notification Rule

The U.S. Federal Trade Commission (FTC) wants to get some feedback on its breach notification requirements intended for non-HIPAA-covered entities that gather personally identifiable health data.

The FTC introduced the Health Breach Notification Rule in 2009 together with the American Recovery and Reinvestment Act of 2009 (ARRA). The regulation became effective on August 22, 2010 and so the FTC began its active enforcement of compliance on February 22, 2010.

Healthcare information collected, stored, or transmitted by covered entities under the Health Insurance Portability and Accountability Act (HIPAA) including healthcare providers, healthcare clearinghouses and health plans, as well as business associates of covered entities is considered as protected health information (PHI).

The FTC’s Health Breach Notification Rule is applicable to personal health records (PHRs), or electronic records that contain personally identifiable health data that are kept, shared and controlled by or mainly for a particular person. The FTC rule is applicable to vendors of personal health records and PHR-associated entities, which are firms that send data to PHRs, provide products and services via PHR websites, or access certain data in PHRs.

All entities governed by the FTC’s Health Breach Notification Rule should send breach notifications to affected people and the FTC with no unreasonable delay and within 60 days from the time the breach was discovered. The FTC should be informed within 10 days of discovering a breach when it affects 500 or more people. When a service provider encounters a breach, the service provider needs to alert the PHR firm. The FTC website posts notices of data breaches impacting 500 or more people.

Every 10 years, the FTC typically evaluates the rules. Within the 10 years since the rule was first passed, the FTC website only published 2 breaches, because the majority of breach reports involved less than 500 records. The FTC additionally reports that enforcement of compliance was not needed because there were limited entities to which the regulation is applicable.

A lot of PHR vendors and associated entities are required to comply with the HIPAA Breach Notification Rule because they are either HIPAA-covered entities or business associates of those entities. Nevertheless, the FTC clarifies that a greater number of entities may soon be subjected to its rule.

As people make use of direct-to-consumer technologies (for instance mobile health apps, virtual assistants, and health tools), for their health data and services, more companies might need to follow the FTC’s Rule.

With the COVID-19 pandemic, the use of these communication platforms has increased considering the HHS temporary refrain from issuing financial penalties on entities that use non-HIPAA-compliant platforms in connection with the rendering of telehealth services. The FTC rule may consequently be more applicable now than 10 years ago.

The FTC wants to get feedback on certain questions concerning the effectiveness, advantages, and relevance of its rule to know whether to keep the rule as it is, scrap it, or update it to improve its benefits on consumers.

The Federal Register will accept comments for 90 days from the date of the rule’s publication. A copy of the request for public comment is available on Bloomberg Law.

CISA Gives New Notification About APT Groups Attacking Healthcare Providers

Advanced Persistent Threat (APT) groups continue to target healthcare organizations, pharmaceutical companies, research organizations, and others engaged in responding to the COVID-19 crisis, forcing another joint notification from cybersecurity authorities in the United Kingdom and the United States.

The previous alert by the UK’s National Cyber Security Centre (NCSC) and the Department of Homeland Security (DHS) Cybersecurity and Infrastructure Security Agency (CISA) was published on April 8, 2020. The current alert gives more details on the strategies, techniques, and processes that APT groups used to access networks and sensitive information.

In the most recent alert, CISA/NCSC mentioned that APT groups are focusing their efforts on organizations engaged in COVID-19 research to get sensitive data on the COVID-19 response as well as research information to boost the domestic research initiatives in nations that give funding to APT groups.

APT groups usually target healthcare providers to get patient personal data, intellectual property, and data that lines up with the country’s priorities. APT groups don’t seem to do attacks in higher numbers, they have changed their target and are now focusing attacks on institutions involved in the COVID-19 response. CISA/NCSC advise that initiatives to get sensitive information are ongoing with national and global healthcare companies being targeted to get sensitive COVID-19 research information.

One type of attack being done is targetiing supply stores, which are considered as a weak link that could be taken advantage of to access higher value victims. Supply chains are vulnerable because a lot of employees of companies in the supply chain are currently operating from home because of the COVID-19 lockdown.

The APT groups are utilizing different strategies to access networks, get control, and steal sensitive information. The alert increases consciousness of two strategies that were discovered in the last few weeks: vulnerabilities exploitation and password spraying.

Plenty of employees working from home while there is pandemic access to their corporate systems through virtual private networks (VPNs). A number of commercial VPN tools were found to have vulnerabilities that attackers are currently exploiting. Last year, VPN solutions from Pulse Secure, Palo Alto Networks, and Fortinet had vulnerabilities but patches were made available to fix the problems. A lot of companies are likewise affected by the Citrix vulnerability, CVE-2019-19781. Though patches were available a few months ago, many companies are still vulnerable to attack because they have not applied the patches. APT groups are scanning for organizations that are still exposed to the Citrix and VPN vulnerabilities and are working on exploiting them.

APT groups are likewise password spraying attacks to access corporate networks. Password spraying is similar to brute force attack that uses often used accounts. The attackers use a frequently used password to check if it permits system access. The same password is then used on several accounts prior to repeating the process with another password. That procedure goes on until the attackers discover the right password. The password spraying tactic is generally successful.

When an attack is successful, the correctly guessed password is utilized for accessing other accounts that probably used the same password. Attackers additionally download global address lists that are employed for other password spraying attacks. The attackers also move laterally, if possible, to steal other credentials and sensitive information.

CISA/NCSC presented the following mitigations  to help healthcare companies strengthen security against these attacks:

  • Ensure VPN clients and infrastructure are up-to-date and use the most recent software versions
  • Patch all software programs and operating systems immediately.
  • Configure multi-factor authentication to block the use of stolen or brute forced passwords to access accounts
  • Protect the management interfaces of crucial systems to keep attackers from getting privileged access to important assets
  • Improve tracking capability to discover network infiltrations.

NSA Cybersecurity Guidance for Teleworkers and Recommended Useful COVID-19 Threat Resources

The National Security Agency has released cybersecurity guidance for teleworkers to help enhance security while working from home. The guidance was introduced mainly for U.S. government workers and military service people. However, it also applies to healthcare sector workers offering telehealth services from home using their PCs and smartphones.

There are lots of communication solutions available for consumers and companies with varying offers of cybersecurity protections. The guidance document discusses 9 essential things to consider when choosing a collaboration program. By evaluating each service based on the 9 requirements, remote employees can select the most suitable solution to satisfy their demands.

The NSA highly advises performing high-level security checks to know how the security functionality of every platform works against particular security standards. These checks are helpful for determining risks related with the functions of each solution. The guidance document additionally gives details on utilizing the collaboration services safely.

The NSA wants the guidance to be assessed by all workers who are currently working from home to enable them to make a smart decision concerning the best communication and collaboration programs that can be used to fulfill their particular needs, and for employees to take the actions laid out in the guidance document to minimize potential cyberattacks.

The guidance document entitled Selecting and Securely Using Collaboration Service for Telework is available for download on this page.

The American Hospital Association (AHA) /American Medical Association (AMA) likewise published healthcare-specific guidance for remote employees. This must be utilized along with NSA guidance.

OCR’s Suggested Resources for Helping Healthcare Organizations Fight COVID-19 Risks

On April 30, 2020, the HHS’ Office for Civil Rights recommended a number of resources addressing the present threat landscape. OCR also recommended actions that need to be taken to lessen risks to a good and right level, as listed below:

Senators Request CISA and U.S. Cyber Command to Create Healthcare-specific Cybersecurity Advice

A group of Senators belonging to two parties wrote to the Cybersecurity and Infrastructure Security Agency (CISA) of the Department of Homeland Security and U.S. Cyber Command asking for healthcare care-specific cybersecurity advice on how to manage coronavirus and COVID-19-associated risks.

Richard Blumenthal, (D-CT), Tom Cotton (R-AR), Mark Warner (D-VA), Edward J. Markey (D-MA) and David Perdue (R-GA) composed the letter because of the increasing cyber espionage and cybercriminal activity directed at the medical care, public health, and research industries all through the COVID-19 outbreak.

The letter mentioned a report published by the cybersecurity company FireEye which pointed out that the Chinese hacking group, APT41, was conducting an important campaign, directed at the healthcare segment. The hacking group is taking advantage of vulnerabilities in networking devices, cloud application and IT management solutions to access healthcare networks – identical systems that are currently being employed by telecommuting employees for giving telehealth at the time of the outbreak. A number of other threat groups having a connection to China have likewise increased their attacks on U.S targets using COVID-19-themed campaigns.

Threat actors from Russia, North Korea and Iran are also doing attacks on international health institutions and public health organizations of U.S. allies. There were a number of false campaigns linked to Russia, China and Iran in an attempt to divert the response of the U.S. to the COVID-19 pandemic.

The healthcare sector already has difficulties protecting against attacks from nation-state threat groups and cybercriminal gangs prior to the SARS-CoV-2 pandemic. Medical providers are now stressed and pressured because of the COVID-19 pandemic and the condition is critical now. In the event that the cyberattacks become successful, there is a big risk of public health response disruption.

Hospitals depend on electronic information like electronic medical records, email communications, and internal networks. Many still use legacy equipment. Any attack can bring about disruption, diversion of resources, and loss of critical time. Even a somewhat minor attack can bring about big disruption. One example is the attack on the Department of Health and Human Services. It was a rather minor technical problem with email, yet it hampered the work of the HHS in organizing the federal government’s service. In case of a ransomware attack, EHRs can be taken out of action causing disruption and potentially grave consequences.

The Senators have asked the two agencies to employ the expertise and assets that were created to fight against these risks and to take the required steps to safeguard the healthcare sector for the duration of the coronavirus pandemic.

The Senators have asked public and private cyber threat intelligence like indicators of compromise from attacks on the medical care, public health, and research industries to be extensively shared to support network defenders prevent the attacks. They have likewise asked the agencies to organize with the HHS, Federal Bureau of Investigation (FBI) and Federal Trade Commission (FTC) to help raise awareness of cybercrime, cyberespionage, and fake information campaigns.

The Senators have requested to provide the National Guard Bureau with threat testing, resources, and extra guidance to help employees working with state public health departments and local emergency management agencies to make sure they have the facts they require to guard critical infrastructure against cybersecurity breaches.

The agencies were asked to speak with partners in the private medical care, public health, and research industries about the resources and data required to enhance protection against attacks, including vulnerability recognition tools and threat hunting.

To stop the fake information campaigns that are being done, the Senators told the agencies to think about giving public statements, the same as the joint statement given regarding election interference on March 2.

Lastly, they told the agencies to assess further required steps to detect and prevent attempts to intrude, manipulate, and meddle with medical care, public health, and research industries.

HHS Holds Off Enforcement of New Interoperability and Data Sharing Regulations

The HHS is going to enforce discretion when it comes to compliance with the latest interoperability and data sharing regulations that the HHS’ Centers for Medicare and Medicaid Services (CMS) and the HHS’ Office of the National Coordinator for Health IT (ONC) released on March 9, 2020.

The final decision to hold off enforcement is because of the COVID-19 outbreak. The ONC, CMS, and HHS’ Office of Inspector General (OIG) are convinced that at this time of the COVID-19 pandemic, healthcare providers should be allowed some versatility in complying with the latest interoperability and data sharing regulations.

There is no change with the dates for complying with the new regulations, though the two agencies are going to exercise enforcement discretion so that healthcare providers can concentrate their efforts on handling the COVID-19 outbreak.

ONC stays dedicated to making sure that patients and healthcare providers can gain access to electronic health information, whenever and wherever it is needed. During this crucial time, resources should be centered on combating the COVID-19 pandemic. To help in the crucial work during this time along with the data sharing initiatives, ONC plans to use enforcement discretion for three months at the conclusion of a number of ONC Health IT Certification Program compliance dates related to the ONC Cures Act Final Rule to give flexibility whilst making sure the objectives of the rule stay on target.

Read the details of the compliance dates and the timetable for ONC’s enforcement discretion on this page.

The CMS is offering healthcare providers 6 months more to comply with its regulation. Patients need to have safe access to their medical information now unlike any other time before. Hospitals ought to do everything that they can to make sure that patients get proper follow-up care. However, with a pandemic this big, it is very important for a healthcare system under attack by COVID-19 to have flexibility. The enforcement discretion will give hospitals 6 months more to follow the new prerequisites.

The ONC, CMS, and OIG will keep on monitoring the implementation scenario to find out if other actions are needed.

Guidance Issued on Allowable PHI Disclosures to First Responders During the COVID-19 Outbreak

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) released additional guidance on HIPAA and COVID-19, the illness resulting from the 2019 Novel Coronavirus or SARS-CoV-2. The latest guidance document gives covered entities the cases of permitted disclosures of protected health information (PHI) according to the HIPAA Privacy Rule to ensure that first responders to people exposed to SARS-CoV-2 or showing signs of COVID-19 can disclose their PHI.

The latest guidance uses a Q&A format and makes clear when covered entities are allowed to share PHI including names and other ID details to first responders, police officers, public health specialists and paramedics without first needing a HIPAA authorization.

The document concurs that the HIPAA Privacy Rule permits disclosures of PHI if the data is necessary to give treatment when the law requires disclosure, when first responders like paramedics are vulnerable to getting COVID-19 and require data to avoid infection, and when disclosure can stop or minimize a critical and impending threat.

OCR additionally stated that a PHI disclosure is allowed whenever a request for PHI is made by a correctional institution or a police officer in legal custody of an inmate or another person, and PHI is needed to provide medical services to the person, to make sure the health and security of a person or other people within the institution, those transporting the person, and when PHI is needed to preserve security, protection, peace and order within a correctional institution.

OCR clarifies that a hospital is allowed to give an EMS dispatch a listing of names and addresses of all people identified to be positive for the COVID-19 test to be used on a per-call basis. The availability of that data ensures that any staff going to a patient’s location in response to an emergency is aware of the need to take extra safety measures, such as putting on personal protective equipment (PPE), to protect their own health and wellbeing.

911 call center personnel may request data concerning a patient’s signs or symptoms to know if there’s a probability of infection with SARS-CoV-2. The data is then handed to law enforcement authorities and other people who responded to an occurrence at the person’s place to make sure they do something to secure themselves.

In all instances, a covered entity should take reasonable attempts to restrict the disclosed data to the least amount required to achieve the reason for the disclosure.

OCR Director Roger Severino stated that the country needs the help of first responders now more than ever and OCR should do all that is necessary to keep them safe while they help other people. This guidance document helps make certain that first responders have access to updated infection data so that they remain safe including the public.

The guidance document entitled COVID-19 and HIPAA: Disclosures to law enforcement, paramedics, other first responders, and public health authorities may be downloaded from the HHS website.

HIPAA Compliance and COVID-19 Coronavirus

No doubt HIPAA covered entities, including healthcare organizations, healthcare clearinghouses, health plans, and business associates of covered entities, have a lot of questions concerning HIPAA compliance and the COVID-19 coronavirus cases. There might be misunderstandings regarding the sharing of information of people who have gotten COVID-19 and those possibly exposed to the 2019 Novel Coronavirus, and with whom data may be shared.

HIPAA Compliance and the COVID-19 Coronavirus Pandemic

There is obviously consternation regarding HIPAA compliance and the COVID-19 Coronavirus pandemic as well as the application of the HIPAA Privacy Rule and Security Rule. Since the start of the HIPAA, there has been no disease outbreak on this enormity ever encountered.

It is essential to take note that the HIPAA Privacy and Security Regulations still apply in the course of a public health emergency like a disease outbreak, and this is applicable to HIPAA compliance and COVID-19. The HIPAA Security Rule makes certain the safety of the protected health information (PHI) of patients and calls for reasonable safety measures to be enforced to prevent impermissible uses and disclosures. The HIPAA Privacy Rule limits the uses and disclosures of PHI to those associated to a treatment plan, bill payment, and healthcare procedures.

Whenever public health emergencies are announced, it is typical for the Secretary of the HHS to give partial HIPAA waivers in areas affected by the emergency. In these situations, particular terms of the HIPAA Privacy Rule are suspended for 72 hours since the time a HIPAA-covered entity follows its disaster procedures. As of March 16, 2020, the Secretary of the HHS has not announced any HIPAA suspensions. Even with no HIPAA waiver, the HIPAA Privacy Rule allows sensible uses and disclosures of patients’ sensitive data.

In February 2020, OCR published a bulletin regarding the 2019 Novel Coronavirus, which confirms what the HIPAA Privacy Rule permits when it comes to sharing patient data while in emergency scenarios, like an infectious disease outbreak. The bulletin summary is detailed below.

Allowed Uses and Disclosures of PHI in Emergency Situations

PHI disclosure is permitted without first getting patient consent for treatment purposes. Disclosures are additionally allowed for coordinating care, for patient referrals, and consultations with other medical experts.

With a condition like COVID-19, it is important to alert public health authorities as they require the details so as to ensure the health and safety of the public. It is allowable to share PHI with public health authorities including the Centers for Disease Control and Prevention (CDC) and others in charge of making sure of the security of the public, like state and local health departments. In these situations, PHI can be disclosed without acquiring consent from a patient.

Disclosures of PHI are likewise allowed to avoid and minimize a serious and impending threat to a particular individual or the public, so long as such disclosures are allowed by other rules. These sorts of disclosures do not need consent from a patient. In such instances, it is the discretion of the medical specialists to evaluate the nature and the seriousness of the threat.

Disclosures of Data to Persons Engaged in a Patient’s Care

The HIPAA Privacy Rule allows disclosures of PHI to people engaged in the health care of a patient like friends, family, caregivers, and other people that the patient identified.

HIPAA covered entities are furthermore allowed to share patient data so as to identify, find, and alert family members, guardians, and other people in charge of the patient’s treatment, regarding the patient’s whereabouts, general condition, or demise. That consists of sharing data with authorities, the media, or even the general public.

In such instances, verbal authorization must be acquired from the patient prior to the disclosure. A healthcare expert should otherwise be able to sensibly infer, using expert judgment, that the patient doesn’t object to a disclosure that is identified to be for the patient’s best interest.

Information may furthermore be shared with disaster relief agencies that are approved by law or charters to help in disaster relief initiatives, for example for organizing the notice of family members or other individuals concerned in the patient’s treatment regarding the location of a patient, their condition, or demise.

The HIPAA Minimum Required Standard Applies

Healthcare specialists should make reasonable efforts to make sure that shared PHI is limited to the minimum required information to accomplish the objective for which the data is being disclosed.

When a public health authority or official asks for the data, covered entities can count on representations from the public health official or authority that the asked for details is the minimum required amount, when that reliance is sensible based on the conditions.

Disclosures With Regards to COVID-19 Patients to the Press

HIPAA is not applicable to press disclosures related to infections, however, HIPAA is applicable to disclosures of HIPAA-covered entities and their business associates to the press. In such instances, the HIPAA-covered entity or business associate may give restricted information in case there is a request regarding a patient by name. The details disclosed ought to be restricted to the general condition of the named individual and the specific area in the facility, given that the disclosure is in line with what the patient desires. The standing of the patient must be described using terms like undetermined, fair, good, critical, serious, treated and released, treated and moved, or dead.

All other data should not be shared with the media or any person not engaged in patient care without first acquiring written permission from the patient concerned.

Disclosures of Data Concerning COVID-19 by Non-HIPAA Covered Entities

It is important to note that HIPAA simply is applicable to HIPAA-covered entities, business associates of HIPAA-covered entities, and subcontractors of business associates. Other entities are not constrained to share information concerning the 2019 Novel Coronavirus and COVID-19; nevertheless, while HIPAA may not be applicable, other federal and state regulations may do.

The HIPAA Privacy Rule covers the communications between companies and workers. HIPAA is not applicable in case a worker informs an employer that he or she has contracted COVID-19 or are on self-quarantine since they are showing signs of COVID-19. HIPAA is applicable in case a hiring manager is told about a worker testing positive by the health plan of the company.

American Medical Association Playbook Dispels Common HIPAA Right of Access Myths

The American Medical Association (AMA) has issued a new HIPAA playbook to enable physicians and their practices to fully grasp the HIPAA Right of Access so that they could comply with this crucial requirement of HIPAA.

Misunderstandings regarding the HIPAA Right of Access may lead to financial charges for noncompliance. The HHS’ Office for Civil Rights presented a new HIPAA Right of Access enforcement initiative in 2019 and has actually taken action against two healthcare companies that were not delivering patients copies of their medical records promptly. Both cases began with a single patient who complained about not being provided with a copy of the requested health records and closed with an $85,000 financial fine.

Patients must get access to their healthcare information so as to make educated decisions regarding their own wellness. Under HIPAA, patients have the right to get hold of a copy of their health records, however, healthcare companies can face difficulties complying with all of the legal specifications of HIPAA. These difficulties, combined with misunderstandings regarding the HIPAA Right of Access, have kept some providers from providing patient requests for copies of their health information.

The Patient Records Electronic Access Playbook was published to teach physicians and their practices regarding the requirement to provide patients access to their medical documents and the legal requirements associated to medical record access and the providing of information to patients.

The 104-page document is split into four components and addresses the legal requirements of HIPAA and patient access laws and the difficulties physician practices encounter when adhering to the HIPAA Right of Access. The playbook consists of guidance to assist doctors to overcome difficulties and recommendations for operationalizing the provision of records access.

The document additionally dispels a number of the common myths regarding providing patients and third parties their health records, the health information that can and cannot be shared, the price that healthcare organizations can ask for providing copies of medical records, and how medical information should be provided.

The playbook clarifies that even though patient portals are being used adherence to the HIPAA Right of Access is not sure. Patient portals do not usually permit patients to access all health data and copies of medical records should still be provided to patients. AMA advises giving patients the chance to access their health information over a number of media. The playbook likewise covers providing health records to third parties upon request, which are two facets of the HIPAA Right of Access that have created misunderstandings for a lot of physician practices.

AMA states in the playbook that healthcare organizations ought to know about the functionality of their EHRs, and explore how patient information could be delivered to other healthcare organizations, how information may be fed into patient sites, and how to copy patient files to USB drives or CDs.

Healthcare organizations must also try to encourage patients to take more interest in their health and acquire a copy of their health information and examine those records for flaws. The patient can be encouraged to use applications and access medical information to become an active winner of his or her health. Patients may better take care of their health by realizing and managing all of their medical information.

Deadline for Reporting 2019 Healthcare Data Breaches With Fewer than 500 Health Records

The HIPAA Breach Notification Rule (45 C.F.R. § 164.408) requires healthcare organizations to report data breaches of 500 or more health records to the Secretary of the Department of Health and Human Services (HHS) no later than 60 days following the discovery of a breach. Breaches of less than 500 health records could be reported to the DHS at any time as long as it is no later than 60 days from the end of the calendar year when the data breach occurred.

That means smaller healthcare data breaches should generally be reported to the HHS by March 1 each year. However, because this year is a leap year, February has an extra day. And so the deadline for reporting smaller breaches is earlier by one day or no later than February 29, 2020.

All breaches should be submitted to the Secretary of the HHS via the Office for Civil Rights breach portal. Each data breach should be reported independently including all the information concerning each breach. In the event that there are a number of small data breaches experienced in the 2020 calendar year, submitting breach reports might take more time. It is thus recommended not to wait until the last minute to send the data breach reports to make sure not to miss the deadline. When data breach reports are submitted later than the 60-day deadline, there will be financial penalties.

When the number of individuals affected by a breach is not yet determined, an estimated number of people affected by the breach should be provided. It is not permissible to delay breach reporting. If the actual number of affected individuals is known, there must be a submission of an addendum. Addenda must also be utilized to update breach reports when there are additional data regarding the breach.

NIST Published Draft Cyber Supply Chain Risk Management Guidance

The Countrywide Institute of Standards and Technology (NIST) has released its latest draft guidance document about cyber supply chain risk management. Its purpose is to help organizations to use an efficient cyber supply risk management system.

Organizations today depend on other organizations to supply vital products and services, however they frequently lose sight of their supply ecosystems. Having third parties to supply products and services may give numerous advantages, however, there are also risks. Threat actors can exploit vulnerabilities in supply chains, in fact, attacks on supply chains are increasing.

In the latter half of 2018, an attack on the Operation ShadowHammer supply chain resulted in the compromise of the software update utility of ASUS. Before the discovery of the cyberattack, around 500,000 users of the ASUS Live Update utility were affected.

The threat group called DragonFly, also known as Energetic Bear, compromised the update website employed by a number of industrial control system (ICS) software makers and put in a backdoor to ICS software program. There were three ICS software makers compromised, causing the malware infection of firms in the field of energy.

Carbon Black published an Incident Threat Report in 2019 and learned that there was an “island hopping” in 50% of attacks. Island hopping is the expression used to refer to cyberattacks on a business, its customers and associates.

The Ponemon Institute conducted the November 2018 Data Risk in the Third-Party Ecosystem study, which showed that 59% of companies were affected by a data breach that happened at a third party supplier. A CrowdStrike report publicized in July 2018 showed that 66% of survey respondents were affected by an attack on the software supply chain.

With increasing supply chain attacks, it is very important that organizations continue to create and put into practice an efficient cyber supply chain risk management plan, however, a lot of organizations have no clue where to begin and those that used this kind of an application do not consider it to be powerful.

NIST has been doing a study on the task of protecting supply chains and has written a number of guidance documents and case studies throughout the last 10 years to assist businesses evaluate and handle supply chain threats. The purpose of the most recent guidance document is to assist institutions to begin with Cyber Supply Chain Risk Management (C-SCRM).

The document consists of a fundamental set of C-SCRM critical practices, which are dependent on industry case studies done in 2015 and 2019, previous NIST research and guidance, and field best practice records. As soon as the fundamental critical practices were followed, more in-depth standards, recommendations, and best practices could then be used to even more strengthen supply chain security.

The latest guidance report – Key Practices in Cyber Supply Chain Risk Management: Observations from Industry (Draft NISTIR 8276) – is available for download here.  NIST welcomes feedback on the draft guidance document up to March 4, 2020.

NIST Privacy Framework Version 1.0 Released for Download Now

Privacy Framework version 1.0 of the National Institute of Standards and Technology (NIST) was issued on January 16, 2020. The objective of the Privacy Framework is to assist institutions of different sizes in their use of personal data including protected health information (PHI) while properly handling privacy issues.

The Privacy Framework is a tool that helps with privacy risk management as well as in achieving and demonstrating compliance with privacy regulations like the Health Insurance Portability and Accountability Act (HIPAA), New York’s Stop Hacks and Improve Electronic Data Security (SHIELD) Act, the California Consumer Privacy Act (CCPA), and the EU’s General Data Protection Regulation (GDPR).

The Privacy Framework could help companies identify the privacy outcomes they want to attain, provide strategies to follow to enhance privacy protections and accomplish those privacy goals, clarify privacy management ideas, and demonstrate how it could be used along with the NIST Cybersecurity Framework and how both work together. NIST states that organizations that have adopted the NIST Cybersecurity Framework and an excellent security posture may not have addressed all of their privacy problems.

Version 1.0 maintains the structure of the September 2019 draft version but features a few updates as an answer to public opinions. Just as with the draft version, the Privacy Framework comprises of three segments:

  1. Core is a set of privacy activities
  2. Profiles assists organizations in determining which activities are needed to accomplish their privacy objectives
  3. Implementation Tiers section leads organizations in the optimization of resources to address privacy problems.

The framework has building blocks that can help you in achieving your privacy goals, such as the laws your organization must adhere to. If you want to increase customer trust by means of offering more privacy-protective products or services, the framework can also help.

The Privacy Framework does not only protect sensitive data such as Social Security numbers, but it also helps protect lower value data including data types that may be combined with others to become sensitive as a unit. New data uses are frequently being identified, like for artificial intelligence. It is thus necessary to use a framework for handling privacy risks instead of having a checklist of tasks to execute. Adopting the Privacy Framework will enable organizations to make policies, procedures, and strategies to protect data, handle privacy risks properly and make sure those risks are managed over time.

The framework will help organizations future-proof their products and services with privacy practices that will adjust to evolving technologies, policies, and new laws. The framework additionally deals with some aspects of privacy that are absent from HIPAA but are notably relevant nowadays due to advancements in technology.

The framework serves as a companion roadmap to point the way toward more research to deal with present privacy challenges. NIST is building a repository of guidance resources to help in the implementation of the framework.

Download the NIST Privacy Framework: A Tool for Improving Privacy through Enterprise Risk Management on NIST’s website (PDF).

Are Schools Covered by the HIPAA?

HIPAA is applicable to healthcare organizations, healthcare clearinghouses, health plans, and business associates of covered entities but is HIPAA applied to schools as well? This post will take a look at the application of HIPAA to schools and how it relates to the Family Educational Rights and Privacy Act (FERPA).

Is HIPAA Applicable to Schools?

Basically, HIPAA isn’t applicable to schools considering that they aren’t HIPAA covered entities, nevertheless, in certain instances a school may be a covered entity in the event that students receive healthcare services. In these circumstances, HIPAA may still not be applicable because any student health details obtained would be listed in the students’ school records and school records are not covered by the HIPAA Privacy Rule yet are protected by FERPA.

A growing number of schools are giving healthcare services to their learners. Medical specialists are employed by a number of schools, several have on-site health centers, and they usually give medicines and provide vaccinations. When providing healthcare services, health data are obtained, recorded, retained, and transmitted. Although a school employs nursing staff, doctors or psychologists, schools aren’t typically classified as covered entities for the reason that they don’t do healthcare transactions digitally for which the Department of Health and Human Services (HHS) has required criteria. Nearly all schools are under this classification as not covered entities hence HIPAA is not applicable.

A number of schools work with a healthcare company that performs digital transactions for which the HHS has required standards. In such cases, the school will be classified as a HIPAA covered entity. The HIPAA Transactions and Code Sets and Identifier Rules ought to be followed when there are digital transactions, but it isn’t required to comply with the HIPAA Privacy Rule in case healthcare information is kept in school records, which are protected by FERPA. In case health data is saved in school records, it’s not classified as protected health information (PHI) and is thus not protected by the HIPAA Privacy Rule. Nevertheless, the school must adhere to FERPA privacy requirements.

One case where the HIPAA Privacy Rule will be applicable is when a healthcare expert delivers medical services like vaccines at the school though he isn’t hired by the school. In this case, the healthcare specialist should abide by the HIPAA, the HIPAA would cover the information while it is retained by the healthcare specialist, and that person ought to acquire authorization prior to the disclosure of health data to the school. If that information is included in the student’s school records, FERPA would apply in lieu of HIPAA.

HIPAA, FERPA and Private Schools

FERPA is applicable to all schools that obtain direct funding by means of programs governed by the Department of Education. FERPA for that reason is applicable to public schools. Private schools aren’t generally covered by FERPA because they get no federal funding from the Department for Education. In case the private school isn’t protected by FERPA, it may or may not be protected by HIPAA based on whether or not it performs digital transactions for which there are criteria mandated by the HHS. In case it does, it should follow HIPAA but if not, the HIPAA and FERPA wouldn’t be applicable.

More Information

To help make clear concerns concerning health data disclosures under FERPA and HIPAA, the HHS’ Office for Civil Rights and the U.S. Department of Education created updates to their combined guidance in December 2019. The revised guidance can be accessed on this page.

DoE and OCR Releases Revised Guidance on Sharing Student Health Records According to FERPA and HIPAA

The Department of Education and the Department of Health and Human Services’ Office for Civil Rights made revisions to the guidance on the sharing of student health records according to the Health Insurance Portability and Accountability Act (HIPAA) and the Family Educational Rights and Privacy Act (FERPA).

The initial guidance document was first published in November 2008 to support school facilitators and healthcare experts to learn the use of FERPA and HIPAA to student academic and healthcare data. The guidance comprises of a couple of Q&As addressing the two rules. Additional Q&As were incorporated to clear up likely areas of misunderstandings concerning how to implement HIPAA and FERPA to student data, including the time it is all right to show student information under FERPA and the HIPAA Privacy Rule with no demand to first get written permission.

HIPAA is applicable to healthcare companies, healthcare clearinghouses, business associates of covered entities and health plans. HIPAA doesn’t typically apply to schools, because medical data obtained by an educational establishment would frequently be categorized as educational data under FERPA. The HIPAA Privacy Rule does not include educational data according to the definition of protected health information (PHI), although there are circumstances where HIPAA and FERPA meet.

The HIPAA Privacy Rule demands getting permission before the sharing of health data for reasons besides treatment, paying bills, or healthcare procedures. The guidance makes clear that in emergencies and cases when a person’s well being is at stake, educational organizations and healthcare companies may make known a student’s health data to somebody able to avert or relieve harm, which includes relatives, friends, health caregivers, and police officers.

The guidance says that healthcare providers could disclose PHI with any person as needed to avert or lower a serious and upcoming threat to the well being or safety of a person, another individual, or the public – in accordance with applicable legislation (including state statutes, case law or regulations) and the provider’s criteria of ethical conduct. It is furthermore allowable to disclose psychotherapy notes and details with regards to mental health concerns and substance abuse issues on particular occasions. The update identifies the occasions when these disclosures are authorized.

OCR Director Roger Severino mentioned that this current resource empowers school administrators, healthcare companies, and mental health specialists by dispelling the belief that HIPAA forbids the disclosure of health records in emergency cases.

The update furthermore comprises data on when PHI or personally identifiable information could be disclosed without risking a student or other people. In addition, the sharing of health records to law enforcement and the National Instant Criminal Background Check System is incorporated in the guidance now.

U.S. Secretary of Education Betsy DeVos says that misunderstandings on when information may be shared should never stop the protection of students while they’re in school. This updated guidance could give the required clarity and help make sure that students receive the support they need, and school managements have the details necessary to safeguard the students.

Six Provisions of HIPAA Security Rule that Help Covered Entities Stop, Minimize, and Recover from Ransomware Attacks

Ransomware attacks are generally performed indiscriminately, since file-encrypting software programs are distributed in bulk spam email campaigns. Nevertheless, since 2017, ransomware attacks are a lot more targeted. Nowadays, cybercriminals choose targets that are more likely to pay the ransom.

Cybercriminal’s primary target are healthcare companies because of the large volumes of sensitive information, low threshold for system downtime, and high demand for information availability. They additionally have the money to pay ransom demands and most are protected by cybersecurity insurance plans. Insurance firms frequently opt to pay the ransom because it is cheaper compared to the cost associated with systems downtime and data restoration from backups.

Because more severe attacks happen more frequently, healthcare companies ought to make certain to have well-protected networks and policies and procedures that give a speedy response in case of an attack.

Ransomware attacks are becoming more sophisticated and new strategies and techniques are continually being created by cybercriminals to access networks and install ransomware. However, most of the attacks still employ proven techniques to give the ransomware payload. The most popular tactics of accessing healthcare networks are still phishing and exploiting vulnerabilities, like flaws unpatched apps and operating systems. By searching and fixing vulnerabilities and strengthening defenses against phishing, healthcare companies can stop all except the most advanced and determined attackers and maintain the security and operations of their networks.

The Department of Health and Human Services explained in its Fall 2019 Cybersecurity Newsletter that most ransomware attacks could be prevented by means of adopting HIPAA Security Rules. By means of HIPAA compliance, healthcare companies can ensure fast recovery in case of a ransomware attack.

Six provisions of the HIPAA Security Rule which are pertinent to securing, mitigating and getting back from ransomware attacks are the following:

Risk Analysis (45 C.F.R. §164.308(a)(1)(ii)(A))

Risk analysis allows healthcare companies to determine threats to the integrity, confidentiality, and availability of ePHI and mitigate those threats. Ransomware is frequently introduced by means of exploiting technical vulnerabilities., including unsecured, open ports, obsolete software, and awful access management/provisioning.

Risk Management (45 C.F.R. §164.308(a)(1)(ii)(B))

All risks identified should be managed and minimized to a low and tolerable level. Doing so will make it more difficult for attackers to be successful. Risk management consists of implementing anti-malware software, spam filters, web filters, intrusion detection systems, and robust backup systems.

Information System Activity Review (45 C.F.R. §164.308(a)(1)(ii)(D))

In case of a breach of an organization’s defenses, intrusions must be immediately detected. By performing information system activity checks, healthcare companies can identify anomalous activity and do something to minimize attacks in progress. Ransomware isn’t always installed upon network access. It could take days, weeks, or months, so doing a system activity check could identify a compromise before ransomware is deployed. Security Information and Event Management (SIEM) solutions may be helpful for doing activity checks and automating the review of logged activities.

Security Awareness and Training (45 C.F.R. §164.308(a)(5))

Phishing attacks often target employees, so it is important to have regular security awareness training for employees. It will help them identify phishing emails and malspam and learn to respond properly by reporting the threats to the IT security group.

Security Incident Procedures (45 C.F.R. §164.308(a)(6))

In case of an attack, a quick response can significantly limit the harm done by ransomware. There must be written policies and procedures, which are properly disseminated to all workforce members so that they know the proper response during an attack. Security processes must be tested to make sure of effectiveness in case of a security breach.

Contingency Plan (45 C.F.R. §164.308(a)(7))

There should be a contingency plan to ensure continuity of critical services and recovery of ePHI in case of a ransomware attack. This means that all ePHI must have backups. Covered entities should likewise test those backups to make sure of data recovery. Threat actors target backups systems to make it more difficult for covered entities to get back if the ransom is not paid. So, there must be at least one backup copy stored safely on a non-networked device or remote system.