Healthcare Data Privacy

DoD IG Discovers Serious Flaws in Navy and Air Force EHR and Security Systems and Potential HIPAA Violations

Posted by HIPAA Journal

A Department of Defense Inspector General (DoDIG) audit of the electronic health record (EHR) and security systems at the Defense Health Agency (DHA), Navy, and Air Force has uncovered serious security vulnerabilities that could potentially be exploited to gain access to systems and protected health information (PHI).

This is the second DoDIG report from recent audits of military training facilities (MTFs). The first report revealed the DHA and Army had failed to consistently implement security protocols to safeguard EHRs and systems that stored, processed, or transmitted PHI. The latest report, which covers the DHA, Navy, and Air Force, has revealed serious vulnerabilities in 11 different areas.

Inconsistency of implementing security protocols to protect EHRs and PHI, and the ineffective administrative, technical, and physical safeguards deployed constitute violations of Health Insurance Portability and Accountability Act (HIPAA) Rules. Those violations could attract financial penalties of up to $1.5 million per violation category.

The DoDIG visited three Navy and two Air Force facilities and assessed 17 information systems across the five locations.

  • Naval Hospital Camp Pendleton, Camp Pendleton, CA
  • San Diego Naval Medical Center, San Diego, CA
  • S. Naval Ship Mercy, San Diego, CA
  • 436th Medical Group, Dover, DW
  • Wright-Patterson Medical Center, Dayton, OH

3 DoD EHR systems, 3 modified DoD EHR systems, 9 service-specific systems, and 2 DHA-owned systems were assessed.

There were instances where vulnerabilities had gone undetected and many cases of detected vulnerabilities failing to be addressed in a reasonable time frame. In its report, DoDIG said the audit at the 436th Medical Group revealed 342 of the 1,430 vulnerabilities identified in May had not been addressed and appeared in the vulnerability scan conducted in June.

The reason for the failure to consistently implement security protocols and address vulnerabilities differed at each audited site, but were largely due to a lack of resources, a lack of guidance, system incompatibility, and vendor limitations.

Security issues were identified in the following areas:

  • Failure to consistently implement multi-factor authentication
  • Failure to configure passwords to meet DoD length/complexity requirements
  • Failure to address known network vulnerabilities
  • Failures to set privileges based on users’ assigned duties
  • Failure to configure controls to lock EHRs after 15 minutes of inactivity
  • Failure to review system activity reports to identify suspicious activities and access attempts
  • Failure to develop standard operating procedures and manage system access
  • Failure to implement appropriate and adequate security protocols to protect ePHI and PHI from unauthorized access
  • Failure to maintain an inventory of all service-specific systems that stored, processed, or transmitted PHI
  • Failure to develop and maintain privacy impact assessments

“Without well-defined, effectively implemented system security protocols, the DHA, Navy, and Air Force compromised the integrity, confidentiality, and availability of PHI”, wrote DoDIG in its report. “Security protocols, when not applied or ineffective, increase the risk of successful cyberattacks; system and data breaches; data loss and manipulation; and unauthorized disclosures of PHI.”

DoDIG made several recommendations to improve security which included configuring systems used to store, process, or transmit ePHI to lock automatically after 15 minutes of inactivity; the development of an oversight plan to ensure recommendations are applied across all locations; actions to be taken to address vulnerabilities in a timely manner; implement procedures to only grant access to systems used to store, process, and transmit Phi based on users’ responsibilities.

DoDIG also recommended the Surgeons General for the Departments of the Navy and Air Force coordinate with the Navy Bureau of Medicine and Surgery and the Air Force Medical Service to assess whether the issues discovered exist at other service-specific military training facilities.

On the whole, the recommendations were accepted, although at certain locations some recommendations remain unresolved and require additional comments.

The DHA Director agreed that the DHA could potentially configure systems to lock after 15 minutes of inactivity, but did not provide assurances that its systems would be changed to incorporate that control.

The Executive Director for the Naval Medical Center, San Diego disagreed with one recommendation. The Military Sealift Command Chief of Staff partly agreed with two recommendations and disagreed with one, but suggested additional controls and alternate actions that could be taken to address all recommendations for the USNS Mercy.

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Class Action Lawsuit Claims UnityPoint Health Mislead Patients over Severity of Phishing Attack

Posted by HIPAA Journal

A class action lawsuit has been filed in response to a data breach at UnityPoint Health that saw the protected health information (PHI) of 16,429 patients exposed and potentially obtained by unauthorized individuals.

As with many other healthcare data breaches, PHI was exposed as a result of employees falling for phishing emails. UnityPoint Health discovered the security breach on February 15, 2018 and sent breach notification letters to affected patients two months later, on or around April 16, 2018.

HIPAA-covered entities have up to 60 days following the discovery of a data breach to issue notifications to patients. Many healthcare organizations wait before issuing breach notifications and submitting reports of the incident to the Department of Health and Human Services’ Office for Civil Rights.

Waiting for two months to issue notifications to breach victims could be viewed as a violation of HIPAA Rules. While the maximum time limit for reporting was not exceeded, the HIPAA Breach Notification Rule requires notifications to be sent ‘without unnecessary delay.’ The HHS’ Office for Civil Rights has taken action over delayed breach notifications in the past, although no penalties have been issued when notification letters have been sent within 60 days of the discovery of a breach.

The notification letters explained to patients that some of their health information had been exposed. The substitute breach notice posted on the UnityPoint Health website in April said the types of information potentially accessed by the attackers included “patient names and one or more of the following: dates of birth, medical record numbers, treatment information, surgical information, diagnoses, lab results, medications, providers, dates of service and/or insurance information. For a limited number of impacted individuals, information that may have been viewed included Social Security Numbers or other financial information.”

UnityPoint Health told patients no reports had been received to suggest that their PHI had been accessed, stolen, or misused.

Patients were encouraged to “remain vigilant in reviewing your account statements for fraudulent or irregular activity”, although the burden of protecting against identity theft and fraud was passed on to patients. Affected individuals were not offered credit monitoring and identity theft protection services nor were they protected by an insurance policy covering misuse of their data.

The lawsuit was filed on May 4 by attorney Robert Teel against Iowa Health Systems Inc., the company that runs UnityPoint Health. Yvonne Mart Fox, of Middleton, WI, lead plaintiff in the class action lawsuit, has accused UnityPoint Health of delaying reporting the breach to regulators and patients. She also alleges UnityPoint Health “misrepresented the nature, breadth, scope, harm, and cost of the privacy breach.”

Fox claims she has suffered sleep deprivation as a direct result of the breach and experiences daily anger. She also claims to have had an increase in the number of automated calls to her cellphone and landline in 2018 and an increase in marketing and other spam emails, which have been attributed to the theft of her contact information.

Fox and other class members are seeking compensatory, punitive, and other damages.

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Massachusetts Physician Convicted for Criminal HIPAA Violation

Posted by HIPAA Journal

Criminal penalties for HIPAA violations are relatively rare, although the Department of Justice does pursue criminal charges for HIPAA violations when there has been a serious violation of patient privacy, such as an impermissible disclosure of protected health information for financial gain or malicious purposes.

One such case has resulted in two criminal convictions – a violation of the Health Insurance Portability and Accountability Act and obstructing a criminal healthcare investigation.

The case relates to the DOJ investigation of the pharmaceutical firm Warner Chilcott over healthcare fraud. In 2015, Warner Chilcott plead guilty to paying kickbacks to physicians for prescribing its drugs and for manipulating prior authorizations to induce health insurance firms to pay for prescriptions. The case was settled with the DOJ for $125 million.

Last week, a Massachusetts gynecologist, Rita Luthra, M.D., 67, of Longmeadow, was convicted for violating HIPAA by providing a Warner Chilcott sales representative with access to the protected health information of patients for a period of 10 months between January 2011 and November 2011.

The access to PHI allowed patients with certain health conditions to be targeted by the firm and facilitated the receipt of prior authorizations for Warner Chilcott pharmaceutical products. When interviewed by federal agents about her relationship with Warner Chilcott, Luthra provided false information and obstructed the investigation.

Luthra had been previously charged for receiving kickbacks from Warner Chilcott in the form of fees for speaker training and speaking at educational events that did not take place. Luthra had accepted payments of approximately $23,500. The DOJ eventually dropped the charges, although the case against the physician continued to be pursued, resulting in the two convictions.

Luthra faces jail time and a substantial fine. The maximum penalty for the HIPAA violation is a custodial sentence of no more than 1 year, one year of supervised release, and a maximum fine of $50,000. The maximum penalty for obstructing a criminal health investigation is no more than 5 years in jail, three years of supervised release, and a fine of up to $250,000.

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Study Reveals Healthcare Industry Employees Struggling to Understand Data Security Risks

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The recently published Beyond the Phish Report from Wombat Security, now a division of Proofpoint, has revealed healthcare employees have a lack of understanding of common security threats.

For the report, Wombat Security conducted a survey of more than 85,000 employees across a wide range of industry sectors. Respondents to the survey were asked questions designed to probe their knowledge of data security.

Respondents were asked about security best practices that would help them avoid ransomware attacks, malware installations, and phishing attacks and established the level of expertise at protecting confidential information, defending against email and web-based scams, securing mobile devices, working safely in remote locations, identifying physical risks, disposing of sensitive information securely, using strong passwords, and safe use of social media and the web.

Overall, the healthcare industry performed second worst for security awareness, just ahead of the hospitality industry, with the survey highlighting several areas of weakness that could potentially be exploited by cybercriminals to gain access to healthcare networks and sensitive data.

Respondents from the healthcare sector performed poorly in several areas, registering a relatively high percentage of incorrect answers related to identifying phishing emails, securely disposing of sensitive information, and protecting mobile devices and sensitive information stored on those devices.

Even though HIPAA requires healthcare employees to dispose of PHI securely, 28% of questions in this area were answered incorrectly. 27% of questions about protecting mobile devices and information were answered incorrectly, as were 26% of questions relating to the protection of confidential information, and 21% of questions on the identification of common security issues and safe use of the Internet.

Overall, respondents from the healthcare industry answered 23% of questions incorrectly, on a par with the manufacturing industry and professional services. Only hospitality industry employees performed worse. The average percentage of incorrect answers across all industry sectors was 19%.

Areas where respondents from the healthcare industry performed best were the use of safe, strong passwords and the identification and prevention of ransomware attacks, with just 12% and 10% of questions answered incorrectly.

“Our hope is that by sharing this data, infosec professionals will think more about the ways they are evaluating vulnerabilities within their organizations and recognize the opportunity they have to better equip employees to apply cybersecurity best practices and, as a result, better manage end-user risk,” said Joe Ferrara, Wombat General Manager.

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How to Defend Against Insider Threats in Healthcare

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One of the biggest data security challenges is how to defend against insider threats in healthcare. Insiders are responsible for more healthcare data breaches than hackers, making the industry unique.

Verizon’s Protected Health Information Data Breach Report highlights the extent of the problem. The report shows 58% of all healthcare data breaches and security incidents are the result of insiders.

Healthcare organizations also struggle to detect insider breaches, with many breaches going undetected for months or even years. One healthcare employee at a Massachusetts hospital was discovered to have been accessing healthcare records without authorization for 14 years before the privacy violations were detected, during which time the records of more than 1,000 patients had been viewed.

Healthcare organizations must not only take steps to reduce the potential for insider breaches, they should also implement technological solutions, policies, and procedures that allow breaches to be detected rapidly when they do occur.

What are Insider Threats?

Before explaining how healthcare organizations can protected against insider threats, it is worthwhile covering the main insider threats in healthcare.

An insider threat is one that comes from within an organization. That means an individual who has authorization to access healthcare resources, which includes EMRs, healthcare networks, email accounts, or documents containing PHI. Resources can be accessed with malicious intent, but oftentimes mistakes are made that can equally result in harm being caused to the organization, its employees, or its patients.

Insider threats are not limited to employees. Any individual who is given access to networks, email accounts, or sensitive information in order to complete certain tasks could deliberately or accidentally take actions that could negatively affect an organization. That includes business associates, subcontractors of business associates, researchers, volunteers, and former employees.

The consequences of insider breaches can be severe. Healthcare organizations can receive heavy fines for breaches of HIPAA Rules and violations of patient privacy, insider breaches can damage an organization’s reputation, cause a loss of patient confidence, and leave organizations open to lawsuits.

According to the CERT Insider Threat Center, insider breaches are twice as costly and damaging as external threats. To make matters worse, 75% of insider threats go unnoticed.

Insider threats in healthcare can be split into two main categories based on the intentions of the insider: Malicious and non-malicious.

Malicious Insider Threats in Healthcare

Malicious insider threats in healthcare are those which involve deliberate attempts to cause harm, either to the organization, employees, patients, or other individuals. These include the theft of protected health information such as social security numbers/personal information for identity theft and fraud, the theft of data to take to new employers, theft of intellectual property, and sabotage.

Research by Verizon indicates 48% of insider breaches are conducted for financial gain, and with healthcare data fetching a high price on the black market, employees can easily be tempted to steal data.

A 2018 Accenture survey conducted on healthcare employees revealed one in five would be prepared to access and sell confidential data if the price was right. 18% of the 912 employees surveyed said they would steal data for between $500 and $1,000.

Alarmingly, the survey revealed that almost a quarter (24%) of surveyed healthcare employees knew of someone who had stolen data or sold their login credentials to an unauthorized outsider.

Disgruntled employees may attempt to sabotage IT systems or steal and hold data in case they are terminated. However, not all acts of sabotage are directed against employers. One notable example comes from Texas, where a healthcare worker used hospital devices to create a botnet that was used to attack a hacking group.

Non-Malicious Insider Threats in Healthcare

The Breach Barometer reports from Protenus/databreaches.net break down monthly data breaches by breach cause, including the number of breaches caused by insiders. All too often, insiders are responsible for more breaches than outsiders.

Snooping on medical records is all too common. When a celebrity is admitted to hospital, employees may be tempted to sneak a look at their medical records, or those of friends, family members, and ex-partners. The motivations of the employees are diverse. The Verizon report suggests 31% of insider breaches were employees accessing records out of curiosity, and a further 10% were because employees simply had access to patient records.

Other non-malicious threats include the accidental loss/disclosure of sensitive information, such as disclosing sensitive patient information to others, sharing login credentials, writing down login credentials, or responding to phishing messages.

The largest healthcare data breach in history – the theft of 78 million healthcare records from Anthem Inc.- is believed to have been made possible because of stolen credentials.

The failure to ensure PHI is emailed to the correct recipient, the misdirection of fax messages, or leaving portable electronic devices containing ePHI unattended causes many breaches each year. The Department of Health and Human Services’ Office for Civil Rights’ breach portal or ‘Wall of Shame’ is littered with incidents involving laptops, portable hard drives, smartphones, and zip drives that have stolen after being left unattended.

How to Defend Against Insider Threats in Healthcare

The standard approach to mitigating insider threats can be broken down into four stages: Educate, Deter, Detect, and Investigate.

Educate: The workforce must be educated on allowable uses and disclosures of PHI, the risk associated with certain behaviors, patient privacy, and data security.

Deter: Policies must be developed to reduce risk and those policies enforced. The repercussions of HIPAA violations and privacy breaches should be clearly explained to employees.

Detect: Healthcare organizations should implement technological solutions that allow them to detect breaches rapidly and access logs should be regularly checked.

Investigate: When potential privacy and security breaches are detected they must be investigated promptly to limit the harm caused. When the cause of the breach is determined, steps should be taken to prevent a recurrence.

Some of the specific steps that can be taken to defend against insider threats in healthcare are detailed below:

Perform Background Checks

It should be standard practice to conduct a background check before any individual is employed. Checks should include contacting previous employers, Google searches, and a check of a potential employee’s social media accounts.

HIPAA training

All healthcare employees should be made aware of their responsibilities under HIPAA. Training should be provided as soon as possible, and ideally before network or PHI access is provided. Employees should be trained on HIPAA Privacy and Security Rules and informed of the consequences of violations, including loss of employment, possible fines, and potential criminal penalties for HIPAA violations.

Implement anti-phishing defenses

Phishing is the number one cause of data breaches. Healthcare employees are targeted as it is far easier to gain access to healthcare data if an employee provides login credentials than attempting to find software vulnerabilities to exploit. Strong anti-phishing defenses will prevent the majority of phishing emails from reaching inboxes. Advanced spam filtering software is now essential.

Security awareness training

Since no technological solution will prevent all phishing emails from reaching inboxes, it is essential – from a security and compliance perspective – to teach employees the necessary skills that will allow them to identify phishing attempts and other email/web-based threats.

Employees cannot be expected to know what actions place data and networks at risk. These must be explained if organizations want to eradicate risky behavior. Security awareness training should also be assessed. Phishing simulation exercises can help to reinforce training and identify areas of weakness that can be tackled with further training.

Encourage employees to report suspicious activity

Employees are often best placed to identify potential threats, such as changes in the behavior of co-workers. Employees should be encouraged to report potentially suspicious behavior and violations of HIPAA Rules.

While Edward Snowden did not work in healthcare, his actions illustrate this well. The NSA breach could have been avoided if his requests for co-workers’ credentials were reported.

Controlling access to sensitive information

The fewer privileges employees have, the easier it is to prevent insider breaches in healthcare. Limiting data access to the minimum necessary amount will limit the harm caused in the event of a breach. You should be implementing the principle of least privilege. Give employees access to the least amount of data as possible. This will limit the data that can be viewed or stolen by employees or hackers that manage to obtain login credentials.

Encrypt PHI on all portable devices

Portable electronic devices can easily be stolen, but the theft of a device need not result in the exposure of PHI. If full disk encryption is used, the theft of the device would not be a reportable incident and patients’ privacy would be protected.

Enforce the use of strong passwords

Employees can be told to use strong passwords or long passphrases, but unless password policies are enforced, there will always be one employee that chooses to ignore those policies and set a weak password. You should ensure that commonly used passwords and weak passwords cannot be set.

Use two-factor authentication

Two-factor authentication requires the use of a password for account access along with a security token. These controls prevent unauthorized access by outsiders, as well as limiting the potential for an employee to use another employee’s credentials.

Terminate access when no longer required

You should have a policy in place that requires logins to be deleted when an employee is terminated, a contract is completed, or employees leave to work for another organization. There have been many data breaches caused by delays in deleting data access rights. Data access should not be possible from the second an employee walks out the door for the last time.

Monitor Employee Activity

If employees require access to sensitive data for work purposes it can be difficult to differentiate between legitimate data access and harmful actions. HIPAA requires PHI access logs to be maintained and regularly checked. Since this is a labor-intensive task, it is often conducted far too infrequently. The easiest way to ensure inappropriate accessing of medical records is detected quickly is to implement action monitoring software and other software tools that can detect anomalies in user activity and suspicious changes in data access patterns.

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Report: Healthcare Data Breaches in Q1, 2018

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The first three months of 2018 have seen 77 healthcare data breaches reported to the Department of Health and Human Services’ Office for Civil Rights (OCR). Those breaches have impacted more than one million patients and health plan members – Almost twice the number of individuals that were impacted by healthcare data breaches in Q4, 2017.

There was a 10.5% fall in the number of data breaches reported quarter over quarter, but the severity of breaches increased. The mean breach size increased by 130.57% and there was a 15.37% increase in the median breach size.

In Q4, 2017, the mean breach size was 6,048 healthcare records and the median breach size was 1,666 records. In Q1, 2018, the mean breach size was 13,945 records and the median breach size was 1,922 records.

Between January 1 and March 31, 2018, 1,073,766 individuals had their PHI exposed, viewed, or stolen compared to 520,141 individuals in Q4, 2017.

Individuals Impacted by Healthcare Data Breaches in Q1, 2018

Healthcare Records Breached in Q1, 2018

Throughout 2017, healthcare data breaches were occurring at a rate of more than one per day. Compared to 2017, January was a relatively good month for the healthcare industry, with just 22 security incidents reported to the HHS’ Office for Civil Rights.

However, January also saw the largest healthcare data breach of the quarter reported – A hacking incident that potentially resulted in the theft of almost 280,000 records. That incident made January the worst month in terms of the number of healthcare records exposed.

The number of reported data breaches also increased each month, In March, breaches were being reported at the typical rate of one per day.

Q1, 2018 Healthcare Data Breaches

Healthcare Data Breaches in Q1, 2018

Main Causes of Healthcare Data Breaches in Q1, 2018

The healthcare industry is something of an anomaly when it comes to data breaches. In other industries, hacking/IT incidents dominate the breach reports; however, the healthcare industry is unique as insiders cause the most data breaches.

Once again, insiders were behind the majority of breaches. Unauthorized access/disclosure incidents, loss of physical records and devices containing ePHI, and improper disposal incidents accounted for 59.74% of the 77 breaches reported in Q1.

The main cause of breaches in Q1, 2018 was unauthorized access/disclosures – 35 incidents and 45.45% of the total breaches reported in Q1. There were 15 breaches involving the loss or theft of electronic devices containing ePHI, all of which could have been prevented had encryption been used.

Causes of Healthcare Data Breaches, Q1, 2018

Healthcare Records Exposed in Q1, 2018 by Breach Cause

Unauthorized access/disclosure incidents were more numerous than hacking incidents in Q1, although more healthcare records were exposed/stolen in hacking/IT incidents than all other causes of breaches combined.

Healthcare Records Exposed by Breach Cause

Location of Breached PHI in Q1, 2018

Healthcare security teams may be focused on securing the perimeter and preventing hackers from accessing and stealing electronic health information, but it is important not to neglect physical records.  As was the case in Q4, 2017, physical records were the top location of breached PHI in Q1, 2018.

Email, which includes social engineering, phishing attacks and misdirected emails, was the second most common location of breached PHI followed by network servers.

Location of Breached PHI - Q1, 2018

Largest Healthcare Data Breaches of Q1, 2018

In Q1, 2018, there were 18 healthcare security breaches that impacted more than 10,000 individuals. Hacking/IT incidents tend to involve more records than any other breach cause, although in Q1, 2018, there were several large-scale unauthorized access/disclosure incidents, including five of the top ten breaches of the quarter.

The two largest breaches of the year to date affected Oklahoma State University Center for Health Sciences and St. Peter’s Surgery & Endoscopy Center. In both cases a hacker gained access to the network and potentially viewed/obtained patients’ PHI.

The five largest breaches of the quarter accounted for 57% of all records exposed in the quarter. The top 18 data breaches accounted for 87% of all records exposed in the quarter.

Name of Covered Entity Covered Entity Type Individuals Affected Type of Breach
Oklahoma State University Center for Health Sciences Healthcare Provider 279865 Hacking/IT Incident
St. Peter’s Surgery & Endoscopy Center Healthcare Provider 134512 Hacking/IT Incident
Tufts Associated Health Maintenance Organization, Inc. Health Plan 70320 Unauthorized Access/Disclosure
Florida Agency Persons for Disabilities Health Plan 63627 Unauthorized Access/Disclosure
Middletown Medical P.C. Healthcare Provider 63551 Unauthorized Access/Disclosure
Onco360 and CareMed Specialty Pharmacy Healthcare Provider 53173 Hacking/IT Incident
Triple-S Advantage, Inc. Health Plan 36305 Unauthorized Access/Disclosure
ATI Holdings, LLC and its subsidiaries Healthcare Provider 35136 Hacking/IT Incident
City of Houston Medical Plan Health Plan 34637 Theft
Mississippi State Department of Health Healthcare Provider 30799 Unauthorized Access/Disclosure
Agency for Health Care Administration Health Plan 30000 Hacking/IT Incident
Decatur County General Hospital Healthcare Provider 24000 Hacking/IT Incident
Barnes-Jewish Hospital Healthcare Provider 18436 Unauthorized Access/Disclosure
Barnes-Jewish St. Peters Hospital Healthcare Provider 15046 Unauthorized Access/Disclosure
Special Agents Mutual Benefit Association Health Plan 13942 Unauthorized Access/Disclosure
Guardian Pharmacy of Jacksonville Healthcare Provider 11521 Hacking/IT Incident
CarePlus Health Plan Health Plan 11248 Unauthorized Access/Disclosure
Primary Health Care, Inc. Healthcare Provider 10313 Unauthorized Access/Disclosure

Healthcare Data Breaches in Q1, 2018 by Covered Entity

Healthcare providers were the worst affected by healthcare data breaches in Q1, 2018. As was the case in Q4, 2017, 14 health plans experienced a breach of more than 500 records. There were half the number of business associate breaches in Q1, 2018 as there were in Q4, 2017.

Q1, 2018 Healthcare Data Breaches by Entity Type

Healthcare Data Breaches in Q1, 2018 by State

In Q1, healthcare organizations based in 35 states reported breaches of more than 500 records. The worst affected state was California with 11 reported breaches, followed by Massachusetts with 8 security incidents.

There were four security incidents in both Missouri and New York, and three breaches reported by healthcare organizations based in Florida, Illinois, Maryland, Mississippi, Tennessee, and Wisconsin.

Healthcare organizations based in Alabama, Arkansas, Kentucky, Rhode Island, Texas, and Wyoming reported two breaches.

There was one breach experienced in Colorado, Connecticut, District of Columbia, Georgia, Iowa, Maine, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, Utah, Virginia, Washington and West Virginia.

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Healthcare Compliance Programs Not In Line With Expectations of Regulators

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Healthcare compliance officers are prioritizing compliance with HIPAA Privacy and Security Rules, even though the majority of Department of Justice and the HHS Office of Inspector General enforcement actions are not for violations of HIPAA or security breaches, but corrupt arrangements with referral sources and false claims. There are more penalties issued by regulators for these two compliance failures than penalties for HIPAA violations.

HIPAA enforcement by the HHS’ Office for Civil Rights has increased, yet the liabilities to healthcare organizations from corrupt arrangements with referral sources and false claims are far higher. Even so, these aspects of compliance are relatively low down the list of priorities, according to a recent survey of 388 healthcare professionals conducted by SAI Global and Strategic Management Services.

The survey was conducted on compliance officers from healthcare organizations of all sizes, from small physician practices to large integrated hospital systems. The aim of the study was to identify the key issues faced by compliance officers and determine how compliance departments are responding and prioritizing their resources.

When asked to rank their main priorities, dealing with HIPAA data breaches was overwhelmingly the top priority and the biggest concerns were HIPAA privacy and security.

The list of HIPAA enforcement actions has grown considerably over the past two years but there are still fewer penalties than for false claims and arrangements with referral sources. Even so, ensuring claims accuracy was only ranked third in compliance officers’ priority list and arrangement with referral sources was ranked fifth. The survey shows there is a gap between what OIG and DOJ consider to be the highest risk areas and where compliance officers see the greatest risks.

“The question has to be asked as to why, in the face the enforcement agencies’ priorities, compliance officers are placing these high risk-areas in a lower priority,” said former HHS Inspector General and CEO of Strategic Management Services Richard Kusserow. “The takeaway from the survey is that compliance officers should be prepared to better align their priorities and programs with those set out by the regulatory and enforcement agencies.”

Part of the reason for the focus on HIPAA compliance is the increase in enforcement activity by OCR in the past two years, the media activity surrounding healthcare data breaches, and the relatively high fines for covered entities discovered not to have fully complied with HIPAA Rules. With OCR investigating all breaches of more than 500 records, and data breaches now occurring with increasing frequency, it is easy to see why HIPAA compliance is being prioritized.

Even though HIPAA is the main priority for compliance officers and where most resources are focused, only one in five compliance officers feels their organization is well prepared for a HIPAA compliance audit. Last year when the survey was conducted, 30% of compliance officers said they were highly confident that they were well prepared for a HIPAA audit. The percentage of compliance officers who said they are moderately prepared for a HIPAA compliance audit has increased from 50% to 61%, showing the focus on HIPAA compliance is having a positive effect.

The study suggests the workload for compliance officers is increasing, but budgets are stagnant. Compliance officers are increasingly responsible for conducting internal audits and providing legal counsel in addition to overseeing compliance with HIPAA Privacy and Security Rules. The high workload and limited resources mean other aspects of compliance are being neglected. According to the report, “Compliance offices are being stretched thin to meet their obligations.”

While external compliance assessments are highly beneficial, only a quarter of respondents said they use independent third parties to complete those assessments, with three quarters performing self-assessments, internal surveys, and using compliance checklists to evaluate their compliance programs.

“The 2018 Healthcare Compliance Benchmark Survey gives us a better understanding of compliance program development in the healthcare sector and suggests that effectiveness is being measured in terms of output, rather than outcome,” said SAI Global CEO Peter Grana. “It is abundantly clear that there is a need for healthcare organizations to remove barriers and increased responsibilities being laid on their compliance offices that distract from the development of effective risk controls.”

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FDA Develops Five-Point Action Plan for Improving Medical Device Cybersecurity

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The past few years have seen an explosion in the number of medical devices that have come to market. While those devices have allowed healthcare providers and patients to monitor and manage health in more ways that has ever been possible, concerns have been raised about medical device cybersecurity.

Medical devices collect, store, receive, and transmit sensitive information either directly or indirectly through the systems to which they connect. While there are clear health benefits to be gained from using these devices, any device that collects, receives, stores, or transmits protected health information introduces a risk of that information being exposed.

The FDA reports that in the past year, a record number of novel devices have been approved for use in the United States and that we are currently enjoying “an unparalleled period of invention in medical devices.” The FDA is encouraging the development of novel devices to address health needs, while balancing the risks and benefits.

The FDA has been working closely with healthcare providers, patients, and device manufacturers to understand and address any risks associated with the devices. Part of the FDA’s efforts in this area involve the development of new frameworks for identifying risks and protecting consumers.

To further protect patients and help reduce risks to a minimal level, the FDA has developed a five-point action plan (PDF). Under the plan the FDA will continue to encourage the development of new devices to address unmet health needs, while also enhancing security controls to ensure patient data remains private and confidential.

Improving Medical Device Cybersecurity

The FDA will be reorganizing its medical device center and will consolidate its premarket and postmarket offices. By leveraging the expert knowledge of staff in both offices and adopting a more integrated approach the FDA will be able to optimize decision-making. The FDA is also adopting a ‘Total Product Life Cycle’ (TPLC) approach to ensure device safety for the entire lifespan of the products.

While risks can be evaluated before the devices come to market, oftentimes those risks are not fully understood until the devices have been released and are being used by a wide range of patients and providers in different settings.

Naturally, when risks are identified in postmarket devices there needs to be a mechanism in place that allows the devices to be updated. The FDA will be exploring various regulatory options to ensure timely mitigations can be implemented, including the ability for all devices to receive updates and security patches to address newly discovered vulnerabilities.

While the FDA can ensure medical device labelling is improved to make providers aware of the safety and effectiveness of the devices, the FDA is considering additional training for providers and further education of users of the devices. The FDA also plans to develop scientific tool kits that can be used by manufacturers to ensure their premarket devices meet safety standards.

To encourage manufacturers to incorporate advanced medical device cybersecurity controls, the FDA is looking into ways it can streamline and speed up the reviewing of devices that meet and exceed safety standards.

The FDA is already promoting “a multi-stakeholder, multi-faceted approach of vigilance, responsiveness, recovery, and resilience” to ensure devices remain safe throughout their entire life cycle. The FDA is also seeking additional funding and authority to develop a public-private CyberMed Safety Analysis Board to assist with medical device cybersecurity issues, vulnerability coordination, and response mechanisms.

Members of the board would include biomedical engineers, clinicians, and cybersecurity experts who would advise both the FDA and device manufacturers on cybersecurity issues and provide assistance with adjudicating disputes.

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Version 1.1 of the NIST Cybersecurity Framework Released

Posted by HIPAA Journal

On April 16, 2018, The National Institute of Standards and Technology released an updated version of its Framework for Improving Critical Infrastructure Cybersecurity (Cybersecurity Framework).

The Cybersecurity Framework was first issued in February 2014 and has been widely adopted by critical infrastructure owners and public and private sector organizations to guide their cybersecurity programs. While intended for use by critical infrastructure industries, the flexibility of the framework means it can also be adopted by a wide range of businesses, large and small, including healthcare organizations.

The Cybersecurity Framework incorporates guidelines, standards, and best practices and offers a flexible approach to cybersecurity. There are several ways that the Framework can be used with ample scope for customization. The Framework helps organizations address different threats and vulnerabilities and matches various levels of risk tolerance.

The Framework was intended to be a living document that can be updated and improved over time in response to feedback from users, changing best practices, new threats, and advances in technology. The new version is the first major update to the framework since 2014 and the result of two years of development.

NIST’s Matt Barrett, program manager for the Cybersecurity Framework, explained that the latest version “refines, clarifies and enhances version 1.0.” While several changes have been made in version 1.1, Barrett explained, “It is still flexible to meet an individual organization’s business or mission needs and applies to a wide range of technology environments such as information technology, industrial control systems and the Internet of Things.”

Version 1.1 of the Cybersecurity Framework includes several updates in response to comments and feedback received in 2016 and 2017 from organizations that have already adopted the Framework.

Version 1.1 sees refinements to the guidelines on authentication, authorization and identity proofing and a better explanation of the relationship between implementation tiers and profiles. The Framework for Cyber Supply Chain Risk Management has been significantly expanded and there is a new section on self-assessment of cybersecurity risk. The section on disclosure of vulnerabilities as also been expanded with a new subcategory added related to the vulnerability disclosure lifecycle.

“Cybersecurity is critical for national and economic security,” said Secretary of Commerce Wilbur Ross. “The voluntary NIST Cybersecurity Framework should be every company’s first line of defense. Adopting version 1.1 is a must do for all CEO’s.”

NIST is also planning to release a companion ‘Roadmap for Improving Critical Infrastructure Cybersecurity’ later this year and will be hosting a webinar later this month to explain and discuss the version 1.1 updates to the Framework.

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