HITECH Act News

2017 HIPAA Enforcement Summary

Our 2017 HIPAA enforcement summary details the financial penalties paid by healthcare organizations to resolve HIPAA violation cases investigated by the Department of Health and Human Services’ Office for Civil Rights (OCR) and state attorneys general.

2017 saw OCR continue its aggressive pursuit of financial settlements for serious violations of HIPAA Rules. There have been 9 HIPAA settlements and one civil monetary penalty in 2017.

In total, OCR received $19,393,000 in financial settlements and civil monetary penalties from covered entities and business associates to resolve HIPAA violations discovered during the investigations of data breaches and complaints.

Last year, there were 12 settlements reached with HIPAA-covered entities and business associates, and one civil monetary penalty issued. In 2016, OCR received $25,505,300 from covered entities to resolve HIPAA violation cases.

Summary of 2017 HIPAA Enforcement by OCR

Listed below are the 2017 HIPAA enforcement activities of OCR that resulted in financial penalties for HIPAA-covered entities and their business associates.

Covered Entity Amount Type Violation Type
Memorial Healthcare System $5,500,000 Settlement Insufficient ePHI Access Controls
Children’s Medical Center of Dallas $3,200,000 Civil Monetary Penalty Impermissible Disclosure of ePHI
Cardionet $2,500,000 Settlement Impermissible Disclosure of PHI
Memorial Hermann Health System $2,400,000 Settlement Careless Handling of PHI
21st Century Oncology $2,300,000 Settlement Multiple HIPAA Violations
MAPFRE Life Insurance Company of Puerto Rico $2,200,000 Settlement Impermissible Disclosure of ePHI
Presense Health $475,000 Settlement Delayed Breach Notifications
Metro Community Provider Network $400,000 Settlement Lack of Security Management Process
St. Luke’s-Roosevelt Hospital Center Inc. $387,000 Settlement Unauthorized Disclosure of PHI
The Center for Children’s Digestive Health $31,000 Settlement Lack of a Business Associate Agreement

OCR’s 2017 HIPAA enforcement activities have revealed covered entities are continuing to fail to comply with HIPAA Rules in key areas: Safeguarding PHI on portable devices, conducting an organization-wide risk analysis, implementing a security risk management process, and entering into HIPAA-compliant business associate agreements with all vendors.

Throughout 2016 and 2017, many covered entities have failed to issue breach notifications promptly. In 2017, OCR took action for this common HIPAA violation and agreed its first HIPAA settlement solely for delaying breach notifications to patients.

HIPAA Desk Audits Revealed Widespread HIPAA Violations

In late 2016, OCR commenced the much-delayed second phase of its HIPAA-compliance audit program. The first stage involved desk audits of 166 HIPAA-covered entities – 103 audits on the Privacy and Breach Notification Rules, and 63 audits on the Security Rule. 41 desk audits were conducted on business associates on the Breach Notification and Security Rules.

While the full results of the compliance audits have not been released, this fall OCR announced preliminary findings from the compliance audits.

Covered entities were given a rating from 1 to 5 for the completeness of compliance efforts on each control and implementation specification. A rating of 1 signifies full compliance with goals and objectives of the standards and implementation specifications that were audited. A rating of 5 indicates there was no evidence that the covered entity had made a serious attempt to comply with HIPAA Rules.

Preliminary Findings of HIPAA Compliance Audits on Covered Entities

Listed below are the findings from the HIPAA compliance audits. A rating of 5 being the worst possible score and 1 being the best.

Preliminary HIPAA Compliance Audit Findings (2016/2017)
HIPAA Rule Compliance Controls Audited Covered Entities Given Rating of 5 Covered Entities Given Rating of 1
Breach Notification Rule (103 audits) Timeliness of Breach Notifications 15 67
Breach Notification Rule (103 audits) Content of Breach Notifications 9 14
Privacy Rule (103 audits) Right to Access PHI 11 1
Privacy Rule (103 audits) Notice of Privacy Practices 16 2
Privacy Rule (103 audits) Electronic Notice 15 59
Security Rule (63 audits) Risk Analysis 13 0
Security Rule (63 audits) Risk Management 17 1

 

Almost a third of covered entities failed to issue breach notifications promptly and next to no covered entities were found to be fully compliant with the HIPAA Privacy and Security Rules.

OCR has delayed the full compliance reviews until 2018. While some organizations will be randomly selected for a full review – including a site visit – OCR has stated that poor performance in the desk audits could trigger a full compliance review. Financial penalties may be deemed appropriate, especially when there has been no attempt to comply with HIPAA Rules.

Attorneys General Fines for Privacy Breaches

The HITECH Act gave state attorneys general the authority to pursue financial penalties for HIPAA violations and assist OCR with the enforcement of HIPAA Rules. Relatively few state attorneys general exercise this right. Instead they choose to pursue cases under state laws, even if HIPAA Rules have been violated.

Notable 2017 settlements with healthcare organizations and business associates of HIPAA covered entities have been listed below.

Covered Entity State Amount Individuals affected Reason
Cottage Health System California $2,000,000 More than 54,000 Failure to Safeguard Personal Information
Horizon Healthcare Services Inc., New Jersey $1,100,000 3.7 million Failure to Safeguard Personal Information
SAManage USA, Inc. Vermont $264,000 660 Exposure of PHI on Internet
CoPilot Provider Support Services, Inc. New York $130,000 221,178 Late Breach Notifications
Multi-State Billing Services Massachusetts $100,000 2,600 Failure to Safeguard Personal Information

The post 2017 HIPAA Enforcement Summary appeared first on HIPAA Journal.

New Bill Aims to Change HIPAA Rules for Healthcare Clearinghouses

A new bill (H.R. 4613) has been introduced to the U.S House of Representatives by Congresswoman Cathy McMorris Rodgers (R-Washington) that proposes changes to the Health Information Technology for Economic and Clinical Health (HITECH) Act and HIPAA Rules for healthcare clearinghouses.

The Ensuring Patient Access to Healthcare Records Act of 2017 is intended to modernize the role of healthcare clearinghouses in healthcare, promote access to and the leveraging of health information, and enhance treatment, quality improvement, research, public health and other functions.

Healthcare clearinghouses are entities that transform data from one format to another, converting non-standard data to standard data elements or vice versa. Healthcare clearinghouses are considered HIPAA-covered entities, although in some cases they can be business associates. The bill – Ensuring Patient Access to Healthcare Records Act of 2017 – would see all healthcare clearinghouses treated as covered entities.

Healthcare clearinghouses gather health data from a wide range of sources, therefore they could hold a complete set of records for each patient. If patients are allowed to obtain copies of their health records from healthcare clearinghouses, it could make it easier for patients treated by multiple providers to obtain a full set of their health records.

“Whether it’s because of a move to a new state, switching providers, an unexpected visit to the emergency room, or a new doctor, patients must track down their own records from numerous different sources based on what they can or cannot remember. It shouldn’t be this burdensome,” said Rodgers. “Our bill gives patients the ability to see a snapshot of their health records at just a simple request, allowing them to make better, more informed healthcare decisions in a timely manner.”

While the bill could improve data access for patients, it has been suggested that patients are unlikely to benefit. Healthcare clearinghouses may have longitudinal health records from multiple sources, but in many cases, they only have claims data rather than a full set of clinical data. Even if patients could be provided with copies, it may not prove to be particularly useful.

Patients can choose which healthcare providers they use, but since a healthcare clearinghouse is not chosen by patients, they are unlikely to know which healthcare clearinghouses actually hold their data. Patients rarely have any dealings with healthcare clearinghouses.

The bill would “allow the use of claims, eligibility, and payment data to produce reports, analyses, and presentations to benefit Medicare, and other similar health insurance programs, entities, researchers, and health care providers, to help develop cost saving approaches, standards, and reference materials and to support medical care and improved payment models.”

This is not the first time that the Ensuring Patient Access to Healthcare Records Act has been introduced. None of the previous versions of the bill have made it to the floor and have attracted considerable criticism. In his Healthcare Blog, Adrian Gropper, MD expressed concern over a previous version of the bill (Senate bill S.3530).

“Extending Covered Entity status to data brokers seems like a quantitative shift and possibly a benefit to patients. But the deceptive part is that unlike today’s Covered Entities (hospitals, pharmacies, and insurance companies), data brokers do not have to compete for the patient’s business,” said Gropper. “By giving the infrastructure business the right to use and sell our data without consent or even transparency, we are enabling a true panopticon – an inescapable surveillance system for our most valuable personal data.”

The post New Bill Aims to Change HIPAA Rules for Healthcare Clearinghouses appeared first on HIPAA Journal.

Data Security and Breach Notification Act Introduced in Senate

The Senate is to vote on a national data breach notification bill – the Data Security and Breach Notification Act – that aims to standardize breach notification requirements across all states. Currently there is a patchwork of data breach notification laws across the United States, each with different reporting requirements. If passed, the Data Security and Breach Notification Act would replace state laws.

While there is a clear need for national standards to ensure all consumers are equally protected regardless of where they live, all previous attempts to introduce nationwide standards for data breach notifications have failed.

The Data Security and Breach Notification Act was introduced by Sen. Bill Nelson (D-FL), with the bill co-sponsored by Sen. Richard Blumenthal (D-CT) and Sen. Tammy Baldwin (D-WI).

Sen. Nelson first introduced the bill in 2015, and introduced a revised version a year later, both of which failed. Announcing the bill, Nelson highlighted the recent Uber data breach, which saw the names, phone numbers, and email addresses of more than 57 million customers and the names and driver’s license details of 600,000 U.S drivers exposed. Uber became aware of the breach in 2016, negotiated with the hackers and paid them $100,000 to destroy the stolen data, and attempted to coverup the breach. Details of the breach were only recently made public.

Following the announcement of the Uber breach, the massive Equifax breach, and other major breaches that have resulted in considerable harm to U.S. consumers, it is hoped that this time around the bill will progress.

Sen. Baldwin said, “The recent data breaches, from Uber to Equifax, will have profound, long-lasting impacts on the integrity of many Americans’ identities and finances, and it is simply unacceptable that millions of them may still not know that they are at risk, nor understand what they can and should do to help limit the potential damage.”

If passed, the Data Security and Breach Notification Act would require notifications of data breaches to be issued to state authorities and breach victims within 30 days of the discovery of a breach.

The breach reporting requirements of the Data Security and Breach Notification Act are tougher than those in most states, as are the penalties for concealing a data breach. Executives of companies that knowingly conceal and fail to report a data breach would face up to five years in jail.

Financial institutions covered by, and in compliance with, the Gramm-Leach-Bliley Act will be deemed to be in compliance with the Data Security and Breach Notification Act, as will organizations that comply with Section 13401 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, or 1173(d) 19 of title XI, part C of the Social Security Act, with respect to data covered by section 13401 of the HITECH Act or the HIPAA Security Rule.

The bill also calls for the Federal Trade Commission (FTC) to develop a new set of security standards that business can follow to help prevent data breaches.

“We need a strong federal law in place to hold companies truly accountable for failing to safeguard data or inform consumers when that information has been stolen by hackers,” said, Sen. Nelson. “Congress can either take action now to pass this long overdue bill or continue to kowtow to special interests who stand in the way of this commonsense proposal.  When it comes to doing what’s best for consumers, the choice is clear.”

The post Data Security and Breach Notification Act Introduced in Senate appeared first on HIPAA Journal.

Lawsuits Filed for Alleged HIPAA and HITECH Act Violations

Two lawsuits have been filed against healthcare organizations over alleged HIPAA and HITECH Act violations.

60 Hospitals Named in Lawsuit Alleging HITECH Act Violations

A recently unsealed complaint, filed in a U.S. District Court in Indiana in 2016, seeks more than $1 billion in damages from 60 hospitals that received HITECH Act meaningful use incentive payments for transitioning to electronic health records, yet failed to meet the requirements of the HITECH Act with respect to providing patients, and their legal representatives, with copies of health records promptly on request.

In order to receive incentive payments, one of the requirements was for hospitals to attest that for at least 50% of patients, they were able to provide copies of medical records within 3 business days of requests being submitted. When copies of health records are requested, the HITECH Act only permits healthcare organizations to charge for labor costs for supplying copies of records.

Michael Misch and Bradley Colborn, attorneys with Anderson, Agostino & Keller, P.C., of South Bend Indiana, investigated hospitals after growing frustrated with the delay in obtaining copies of health records at their clients’ request, and over the amounts being charged for copies of health records.

The aim of the investigation was to streamline requests, reduce the time taken to obtain copies of health records, and reduce the cost of accessing those records. However, the investigation revealed that many hospitals were failing to meet the requirements of the HITECH Act, even though they had received incentive payments for compliance.

In the complaint, it is alleged that 60 hospitals received payments of $324.4 million in HITECH Act grant funding, yet failed to meet the requirements of the HITECH Act when it came to providing copies of health records of patients. The lawsuit also alleges the hospitals violated the Anti-Kickback Statute and the False Claims Act; falsely claiming compliance with HITECH Act to gain access to public funding.

Patient Sues BJC Health System Over Barnes-Jewish Hospital Breach

A patient whose protected health information was exposed as a result of a security breach at Barnes-Jewish Hospital in St. Louis, MO, has filed a complaint in the St. Louis Circuit Court against the hospital operator, BJC Health System.

Megan L. Rosemann claims BJC Health System allowed unauthorized individuals to gain access to the protected health information of patients and failed to adequately protect patient data. She alleges BJC Health System was negligent and breached its fiduciary duty.

Rosemann claims the exposure of her information places her at an increased risk of identity theft, abuse, and exploitation. The lawsuit names Rosemann as the plaintiff, along with other individuals affected by the breach. Rosemann is seeking a class certification and trial by jury. A jury trial has been scheduled for May 14, 2018.

BJC Healthcare reported the unauthorized accessing of an email account to the Department of Health and Human Services’ Office for Civil Rights on February 26, 2016. The breach impacted 2,393 patients. The case is still marked as under investigation by OCR.

The post Lawsuits Filed for Alleged HIPAA and HITECH Act Violations appeared first on HIPAA Journal.

Tips for Reducing Mobile Device Security Risks

An essential part of HIPAA compliance is reducing mobile device security risks to a reasonable and acceptable level.

As healthcare organizations turn to mobiles devices such as laptop computers, mobile phones, and tablets to improve efficiency and productivity, many are introducing risks that could all too easily result in a data breach and the exposure of protected health information (PHI).

As the breach reports submitted to the HHS’ Office for Civil Rights show, mobile devices are commonly involved in data breaches. Between January 2015 and the end of October 2017, 71 breaches have been reported to OCR that have involved mobile devices such as laptops, smartphones, tablets, and portable storage devices. Those breaches have resulted in the exposure of 1,303,760 patients and plan member records.

17 of those breaches have resulted in the exposure of more than 10,000 records, with the largest breach exposing 697,800 records. The majority of those breaches could have easily been avoided.
The Health Insurance Portability and Accountability Act (HIPAA) Security Rule does not demand encryption for mobile devices, yet such a security measure could have prevented a high percentage of the 71 data breaches reported to OCR.

When a mobile device containing ePHI is lost or stolen, the HIPAA Breach Notification Rule requires the breach to be reported and notifications to be sent to affected individuals. If PHI has been encrypted and a device containing ePHI is lost or stolen, notifications need not be sent as it would not be a HIPAA data breach. A breach report and patient notifications are only required for breaches of unencrypted PHI, unless the key to decrypt data is also obtained.

Even though HIPAA does not demand the use of encryption, it must be considered. If the decision is taken not to encrypt data, the decision must be documented and an alternative safeguard – or safeguards – must be employed to ensure the confidentiality, integrity, and availability of ePHI. That alternative safeguard(s) must provide a level of protection equivalent to encryption.

Before the decision about whether or not to encrypt data can be made, HIPAA covered entities must conduct an organization-wide risk analysis, which must include all mobile devices. All risks associated with the use of mobile devices must be assessed and mitigated – see 45 C.F.R. § 164.308(a)(1)(ii)(A)–(B).

OCR Reminds Covered Entities of Need to Address Risks Associated with Mobile Devices

In its October 2017 Cybersecurity Newsletter, OCR reminded covered entities of the risks associated with mobile devices that are used to create, receive, maintain, or transmit ePHI. HIPAA covered entities were reminded of the need to conduct an organization-wide risk assessment and develop a risk management plan to address all mobile device security risks identified during the risk analysis and reduce them to an appropriate and acceptable level.

While many covered entities allow the use of mobile devices, some prohibit the use of those devices to create, receive, maintain, or transmit ePHI. OCR reminds covered entities that if such a policy exists, it must be communicated to all staff and the policy must be enforced.

When mobile devices can be used to create, receive, maintain, or transmit ePHI, appropriate safeguards must be implemented to reduce risks to an appropriate and acceptable level. While loss or theft of mobile devices is an obvious risk, OCR draws attention to other risks associated with the devices, such as using them to access or send ePHI over unsecured Wi-Fi networks, viewing ePHI stored in the cloud, or accessing or sharing ePHI via file sharing services.

OCR also remined covered entities to ensure default settings on the devices are changed and how healthcare employees must be informed of mobile device security risks, taught best practices, and the correct way to uses the device to access, store, and transmit ePHI.

OCR offers the following advice to covered entities address mobile security risks and keep ePHI secure at all times.

To access OCR’s guidance – Click here.

OCR’s Tips for Reducing Mobile Device Security Risks

  • Implement policies and procedures regarding the use of mobile devices in the work place – especially when used to create, receive, maintain, or transmit ePHI.
  • Consider using Mobile Device Management (MDM) software to manage and secure mobile devices.
  • Install or enable automatic lock/logoff functionality.
  • Require authentication to use or unlock mobile devices.
  • Regularly install security patches and updates.
  • Install or enable encryption, anti-virus/anti-malware software, and remote wipe capabilities.
  • Use a privacy screen to prevent people close by from reading information on your screen.
  • Use only secure Wi-Fi connections.
  • Use a secure Virtual Private Network (VPN).
  • Reduce risks posed by third-party apps by prohibiting the downloading of third-party apps, using whitelisting to allow installation of only approved apps, securely separating ePHI from apps, and verifying that apps only have the minimum necessary permissions required.
  • Securely delete all PHI stored on a mobile device before discarding or reusing the mobile device.
  • Include training on how to securely use mobile devices in workforce training programs.

Penalties for Failing to Address Mobile Security Risks

The failure to address mobile device security risks could result in a data breach and a penalty for noncompliance with HIPAA Rules. Over the past few years there have been several settlements reached between OCR and HIPAA covered entities for the failure to address mobile device security risks.

These include:

Covered Entity HIPAA Violation Individuals Impacted Penalty
Children’s Medical Center of Dallas Theft of unencrypted devices 6,262 $3.2 million
Oregon Health & Science University Loss of unencrypted laptop / Storage on cloud server without BAA 4,361 $2,700,000
Cardionet Theft of an unencrypted laptop computer 1,391 $2.5 million
Catholic Health Care Services of the Archdiocese of Philadelphia Theft of mobile device 412 $650,000

Addressing Mobile Device Security Risks

Mobile device security risks must be reduced to a reasonable and appropriate level.  Some of the mobile device security risks, together with mitigations, have been summarized in the infographic below. (Click image to enlarge)

mobile device security risks

The post Tips for Reducing Mobile Device Security Risks appeared first on HIPAA Journal.

53% of Businesses Have Misconfigured Secure Cloud Storage Services

The healthcare industry has embraced the cloud. Many healthcare organizations now use secure cloud storage services to host web applications or store files containing electronic protected health information (ePHI).

However, just because secure cloud storage services are used, it does not mean data breaches will not occur, and neither does it guarantee compliance with HIPAA. Misconfigured secure cloud storage services are leaking sensitive data and many organizations are unaware sensitive information is exposed.

A Business Associate Agreement Does Not Guarantee HIPAA Compliance

Prior to using any cloud storage service, HIPAA-covered entities must obtain a signed business associate agreement from their service providers.

Obtaining a signed, HIPAA-compliant business associate agreement prior to the uploading any ePHI to the cloud is an important element of HIPAA compliance, but a BAA alone will not guarantee compliance. ePHI can easily be exposed if cloud storage services are not configured correctly.

As Microsoft explains, “By offering a BAA, Microsoft helps support your HIPAA compliance, but using Microsoft services does not on its own achieve it. Your organization is responsible for ensuring that you have an adequate compliance program and internal processes in place, and that your particular use of Microsoft services aligns with HIPAA and the HITECH Act.”

Configure your account correctly and your data will be secure. Make a mistake and data will be exposed and you could easily violate HIPAA Rules.

Misconfigured Secure Cloud Storage Services

When it comes to secure cloud storage, many organizations believe their cloud environments have been secured, but that is often not the case. How many businesses are leaving data exposed? According to a recent study by cloud threat defense firm RedLock, more than half of businesses have made mistakes that have exposed sensitive data in the cloud.

The report reveals many organizations are not following established security best practices, such as using multi-factor authentication for all privileged account users. To make matters worse, many businesses are failing to monitor their cloud environments which means data is being exposed, but not detected.

The problem appears to be getting worse. RedLock’s last analysis for Q2 revealed 40% of businesses had misconfigured at least one of their cloud storage services – Amazon Simple Storage Service (Amazon S3) for example. A new analysis, published in its latest Cloud Security Trends Report, shows that percentage jumped to 53% between June and September 2017.

Key Findings

  • 53% of organizations have at least one exposed cloud storage service
  • 38% of users exposed data through compromised administrative user accounts
  • 81% are not managing host vulnerabilities in the cloud
  • 37% of databases accept inbound connection requests from suspicious IP addresses
  • 64% of databases are not encrypted
  • 45% of Center of Internet Security (CIS) compliance checks are failed
  • 48% of Payment Card Industry Data Security Standard (PCI DSS) compliance checks fail
  • 250 organizations were found to be leaking credentials to their cloud environments on internet-facing web servers

Cloud Misconfigurations Result in Data Breaches

One need look no further than the widespread misconfigured MongoDB installations that were discovered by hackers in January 2017. Misconfigured databases were plundered, data deleted, and ransom demands issued. More than 26,000 MongoDB databases were hijacked and held for ransom.

Is it not just small organizations that are making errors that are resulting in data exposure and data breaches. The Equifax data breach, which saw the records of more than 143 million Americans exposed, was the result of the failure to address a known vulnerability in Apache Struts; a framework that supported its dispute portal web application. Equifax CEO Richard Smith recently told the House Energy and Commerce Committee that the missed patch was due to a mistake by a single employee.

British insurance giant Aviva found out one of its cloud environments had been ‘hacked’ and was being used to mine Bitcoin. Kubernetes administration consoles were used to gain access to its cloud environment with ease. Its administration consoles lacked passwords.

RedLock is not the only company to report on the problem. IBM X-Force said it has tracked more than 1.3 billion records that were exposed as a result of misconfigured servers up to September 2017.

Training will only go so far. You can train your employees never to leave the firewall turned off, yet occasionally that happens. Bad errors can also occur in the cloud that will similarly lead to data breaches. Leave the door open to hackers and they will infiltrate cloud environments, steal data, and hold organizations to ransom.

What organizations must do is to make sure all doors have been closed and locked. Unless organizations proactively monitor their cloud environments, they will be unaware there is a problem until it is too late.

The post 53% of Businesses Have Misconfigured Secure Cloud Storage Services appeared first on HIPAA Journal.

What are the HIPAA Breach Notification Requirements?

All HIPAA covered entities must familiarize themselves with the HIPAA breach notification requirements and develop a breach response plan that can be implemented as soon as a breach of unsecured protected health information is discovered.

While most HIPAA covered entities should understand the HIPAA breach notification requirements, organizations that have yet to experience a data breach may not have a good working knowledge of the requirements of the Breach Notification Rule. Vendors that have only just started serving healthcare clients may similarly be unsure of the reporting requirements and actions that must be taken following a breach.

The issuing of notifications following a breach of unencrypted protected health information is an important element of HIPAA compliance. The failure to comply with HIPAA breach notification requirements can result in a significant financial penalty. With this in mind, we have compiled a summary of the HIPAA breach notification requirements for covered entities and their business associates.

Summary of the HIPAA Breach Notification Requirements

The HIPAA Breach Notification Rule – 45 CFR §§ 164.400-414 – requires covered entities and their business associates to report breaches of electronic protected health information and physical copies protected health information. A breach is defined as the acquisition, access, use, or disclosure of protected health information in a manner not permitted by HIPAA Rules.

HIPAA breaches include unauthorized access by employees as well as third parties, improper disclosures, the exposure of protected health information, and ransomware attacks. Exceptions include: Breaches of secured protected health information such as encrypted data when the key to unlock the encryption has not been obtained; “any unintentional acquisition, access, or use of protected health information by a workforce member or person acting under the authority of a covered entity or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure;” An inadvertent disclosure by a person who is authorized to access PHI, to another member of the workforce at the organization who is also authorized to access PHI; When the covered entity or business associate makes a disclosure and has a good faith belief that the information could not have been retained by the person to whom it was disclosed.

In the event of a reportable HIPAA breach being experienced, the HIPAA breach notification requirements are:

Notify Individuals Impacted – or Potentially Impacted – by the Breach

All individuals impacted by a data breach, who have had their protected health information accessed, acquired, used, or disclosed, must be notified of the breach. Breach notifications are also required for any individual who is reasonably believed to have been affected by the breach.

Breach notification letters must be sent within 60 days of the discovery of a breach unless a request to delay notifications has been made by law enforcement. In such cases, notifications should be sent as soon as that request has expired. While it is permissible to delay reporting of a breach to the HHS for breaches impacting fewer than 500 individuals (see below), that delay does not apply to notifications to breach victims.

Breach notification letters should be sent by first class mail to the last known address of breach victims, or by email if individuals have given authorization to be contacted electronically.

The HIPAA breach notification requirements for letters include writing in plain language, explaining what has happened, what information has been exposed/stolen, providing a brief explanation of what the covered entity is doing/has done in response to the breach to mitigate harm, providing a summary of the actions that will be taken to prevent future breaches, and giving instructions on how breach victims can limit harm. Breach victims should also be provided with a toll-free number to contact the breached entity for further information, together with a postal address and an email address.

Notify the Department of Health and Human Services

Notifications must be issued to the Secretary of the Department of Health and Human Services, via the Office for Civil Rights breach reporting tool. The HIPAA breach notification requirements differ depending on how many individuals have been impacted by the breach.

When the breach has impacted more than 500 individuals, the maximum permitted time for issuing the notification to the HHS is 60 days from the discovery of the breach, although breach notices should be issued without unnecessary delay. In the case of breaches impacting fewer than 500 individuals, HIPAA breach notification requirements are for notifications to be issued to the HHS within 60 days of the end of the calendar year in which the breach was discovered.

Notify the Media

HIPAA breach notification requirements include issuing a notice to the media. Many covered entities that have experienced a breach of protected health information notify the HHS, relevant state attorneys general, and the patients and health plan members impacted by the breach, but fail to issue a media notice – a violation of the HIPAA Breach Notification Rule.

A breach of unsecured protected health information impacting more than 500 individuals must be reported to prominent media outlets in the states and jurisdictions where the breach victims reside – See 45 CFR §§ 164.406. This is an important requirement, as up-to-date contact information may not be held on all breach victims. By notifying the media, it will help to ensure that all breach victims are made aware of the potential exposure of their sensitive information. As with the notifications to the HHS and breach victims, the media notification must be issued within 60 days of the discovery of the breach.

Post a Substitute Breach Notice on the Home Page of the Breach Entity’s Website

In the event that up-to-date contact information is not held on 10 or more individuals that have been impacted by the breach, the covered entity is required to upload a substitute breach notice to their website and link to the notice from the home page. The link to the breach notice should be displayed prominently and should remain on the website for a period of 90 consecutive days. In cases where fewer than 10 individuals’ contact information is not up-to-date, alternative means can be used for the substitute notice, such as a written notice or notification by telephone.

Data Breaches Experienced by HIPAA Business Associates

Business associates of HIPAA-covered entities must also comply with the HIPAA breach notification requirements and can be fined directly by the HHS’ Office for Civil Rights and state attorneys general for a HIPAA Breach Notification Rule violation.

Any breach of unsecured protected health information must be reported to the covered entity within 60 days of the discovery of a breach. While this is the absolute deadline, business associates must not delay notification unnecessarily. Unnecessarily delaying notifications is a violation of the HIPAA Breach Notification Rule.

It is usually the covered entity that will issue breach notifications to affected individuals, so any breach notification will need to be accompanied with details of the individuals impacted. It is a good practice to issue a breach notification to a covered entity rapidly, and to provide further information on the individuals impacted once the investigation has been completed. Under the terms of a HIPAA-compliant Business Associate Agreement (BAA), a business associate may be required to issue breach notifications to affected individuals.

Timeline for Issuing Breach Notifications

Breach notifications should be issued as soon as possible and no later than 60 days after the discovery of the breach, except when a delay is requested by law enforcement. Investigating a breach of protected health information can take some time, but once all the necessary information has been obtained to allow breach notifications to be sent they should be mailed.

HIPAA-covered entities must not delay sending breach notification letters. It is possible to receive a HIPAA violation penalty for delaying notifications, even if they are sent within 60 days of the discovery of the breach. There have been several recent cases of HIPAA breach notification requirements not being followed within the appropriate time frame, which can potentially result in financial penalties.

State Breach Notification Laws May Be Stricter than HIPAA

U.S. states have their own breach notification laws. Typically, notifications must be issued to breach victims promptly and a notice also submitted to the state attorney general’s office. Some states require breach notifications to be issued well within the HIPAA deadline.

Delaying breach notifications until the 60-day limit of HIPAA could well see state laws violated, leading to financial penalties from state attorneys general. State laws frequently change so it is important to keep up to date on breach notification laws in the states in which you operate.

Penalties for Violations of HIPAA Breach Notification Requirements

HIPAA covered entities must ensure the HIPAA breach notification requirements are followed or they risk incurring financial penalties from state attorneys general and the HHS’ Office for Civil Rights.

In 2017, Presense Health became the first HIPAA-covered entity to settle a case with the Office for Civil Rights solely for a HIPAA Breach Notification Rule violation – after it exceeded the 60-day maximum time frame for issuing breach notifications. Presense Health took three months from the discovery of the breach to issue notifications – A delay that cost the health system $475,000. The maximum penalty for a HIPAA Breach Notification Rule violation is $1,500,000, or more if the delay is for more than 12 months.

The post What are the HIPAA Breach Notification Requirements? appeared first on HIPAA Journal.

Is OneDrive HIPAA Compliant?

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

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

Microsoft Supports HIPAA-Compliance

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

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

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

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

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

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

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

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

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

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

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

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

The post Is OneDrive HIPAA Compliant? appeared first on HIPAA Journal.

August Sees OCR Breach Reports Surpass 2,000 Incidents

Following the introduction of the HITECH Act in 2009, the Department of Health and Human Services’ Office for Civil Rights has been publishing summaries of healthcare data breaches on its Wall of Shame.  August saw an unwanted milestone reached. There have now been more than 2,000 healthcare data breaches (impacting more than 500 individuals) reported to OCR since 2009.

As of today, there have been 2,022 healthcare data breaches reported. Those breaches have resulted in the theft/exposure of 174,993,734 individuals’ protected health information. Healthcare organizations are getting better at discovering and reporting breaches, but the figures clearly show a major hike in security incidents. In the past three years, the total has jumped from around 1,000 breaches to more than 2,000.

The recent KPMG 2017 Cyber Healthcare & Life Sciences Survey showed that 47% of healthcare organizations have experienced a data breach in the past two years, up from 37% in 2015 when the survey was last conducted. An ITRC/CyberScout study showed there has been a 29% increase in data breaches so far in 2017.

In contrast to other industries, the biggest cause of data breaches is insiders (Protenus/databreaches.net): Both deliberate actions by ‘bad apples’ and accidental breaches as a result of simple errors and negligence. Hacking (including malware/ransomware attacks) is the second biggest cause.

Healthcare Organizations Should Not Ignore the Threat from Phishing

Many healthcare data breaches occur as a result of phishing. Research conducted by PhishMe suggests 91% of data breaches start with a phishing email, with the attackers using phishing to obtain login credentials or install malware/ransomware.

A recent Global Threat Intelligence Report released by NTT Security showed the extent to which phishing is used to distribute malware. In Q2, 2017, 67% of malware attacks saw malware delivered via phishing emails.

Jon Heimerl, manager of the Threat Intelligence communications team, pointed out that while phishing is used extensively to spread malware, it isn’t often rated as one of the biggest threats. Heimerl said, “I have not seen any studies where CISOs are saying their No. 1 concern is phishing attacks. If you went around a room, it would likely be ransomware and DDoS as the No. 1 and No. 2 things on their mind, in my view.”

Countering the threat from phishing requires software solutions to block spam emails from being delivered to end users, security awareness training to teach employees how to identify email threats, and phishing simulations to put security awareness training to the test and identify vulnerable individuals in need of further training.

New Exploit Kit and Recent Ransomware Attacks Highlight Importance of Prompt Patching

Email remains the main delivery vector for malware, although the WannaCry attacks showed that malware can easily be installed if patch management practices are poor. The ransomware attacks were made possible thanks to the release of exploits by the hacking group Shadow Brokers and poor patching practices.  Prompt patching would have protected organizations against WannaCry.

Exploit kits also pose a threat. Exploit kits are web-based tools that probe for vulnerabilities in browsers and plugins. Exploits are loaded to the kit that are used to silently download malware when a visitor to a domain hosting the kit is discovered to have a vulnerable browser.

This week, a new exploit kit has started to be offered on underground forums at cut price rates. For as little as $80 a day, cybercriminals can rent the new Disdain exploit kit and use it to spread malware. Exploit kit activity has fallen over the past 12 months, although the threat of web-based attacks should not be ignored.

The Disdain exploit kit can leverage at least 15 vulnerabilities to download malicious payloads, including vulnerabilities in Firefox (CVE-2017-5375, CVE-2016-9078, CVE-2014-8636, CVE-2014-1510, CVE-2013-1710), Internet Explorer (CVE-2017-0037, CVE-2016-0189, CVE-2015-2419, CVE-2014-6332, CVE-2013-2551), IE and Edge (CVE-2016-7200), Adobe Flash (CVE-2016-4117, CVE-2016-1019, CVE-2015-5119), and Cisco Web Ex (CVE-2017-3823). While many of these vulnerabilities are relatively new, patches have been released to address all of the flaws.

 

To reduce the risk of exploit kit attacks, healthcare organizations should ensure all browsers are updated automatically and regular checks are performed to ensure all employees are using the latest versions. A web filtering solution is also beneficial to block access to domains known to be used for malware distribution, host exploit kits or phishing.

The post August Sees OCR Breach Reports Surpass 2,000 Incidents appeared first on HIPAA Journal.