Howard Schmidt, Obama administration's cyber security czar, prepared a fantastic presentation about the four guiding principles of his cyber security plan:
Deterrence is a primary factor in preventing cyber security threats. Applying strong protectionlike two factor authentication, one time passwords, smart cards, and implementing standard data protection systems were mentioned.
Resilience is the ability to recover from an attack. Designing systems that are able to recover from an attack is paramount to national security, and especially protected health information (PHI). It was noted (in a different part) of the NIST Conference that doctors relying on Health information systems (HIT) need to ensure that a disaster recovery and backup plan is in place and is tested regularly. A doctor’s office or a hospital would be nearly impossible to operate if access to PHI is not available after moving entirely to electronic medical records.
Privacy is important to the White House. It’s clear that legislation and the regulations that follow have privacy in mind. An good example is the Breach Notification law written into section 13402 in the HITECH ACt, part of the American Recovery and Reinvestment Act of 2009 (ARRA). The HITECH Act specifically provides safe harbors in case of a breach of encrypted PHI. The government is clearly incentivizing the use of data encryption to protect privacy.
Partnerships with private industry were mentioned as well, although not in too much detail. Perhaps the White House wants to make sure that whatever steps they put in place have transparency to the public and the private industry.
In order to help the government and private industry standardize on a risk management process NIST created the RMF - Risk Management Framework. The framework into 6 steps:
Categorize the information systems
Select security controls
Implement security controls
Access security controls
Authorize information systems
Monitor security controls
At the 2010 NIST HIPAA Security Conference presentation, Pat Toth, a computer scientist working for NIST , discussed the importance of the integrating risk management and security into your enterprise computing environment. Security is often thought of as an after-the-fact process that becomes important after IT systems and applications are deployed. Toth pointed out that our perception of security’s role needs to change in order to protect the our healthcare information systems.
The HIPAA security rule specifically requires that a risk assessment be performed on IT systems that contain PHI (protected health information). Rather than creating the assessment from scratch the RMF is a great place to start your research and perhaps implement the steps recommended by NIST to secure your HIT systems.
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The RMF is of particular importance for helping to obtain a safe harbor from penalties in the HIPAA security rule, particularly when deciding to implement (or not implement) technologies like data encryption. For example: if you decide that encryption is not needed in your environment and an incident happens where PHI is breached you will need to show the reason behind your decisions to HHS OCR (U.S Department of Health and Human Services, Office of Civil Rights).
Beginning on February 18, HHS will have the legal authority to enforce the breach notification laws set forth last year as part of section 13402 of the HITECH Act, within the American Recovery & Reinvestment Act (ARRA). The penalties can now be up to $1.5 million and require media notification in cases where 500 or more records are breached. Business associates, as well as covered entities, must now comply with the HITECH Act breach notification rule (which essentially makes modifications to the HIPAA Security Rule).
Perform an extensive security review and indentify where electronic protected health information (PHI or ePHI) resides on your IT systems.
Create a plan on protecting PHI.
Data encryption provides a safe harbor from breach notification. Determine where PHI can be encrypted.
Identify public facing extranet portals and web applications that can allow access to PHI.
Identify databases that hold PHI.
Execute the plan
Implement data encryption where practical.
For databases, implement a database security product to monitor database requests and protect from intrusion.
For web apps, implement a web application security product to protect from cross-site scripting and various attacks to access databases to PHI.
Protect endpoints such as laptops, tablets, etc with data at rest encryption by implementing whole disk encryption,
Experior Data helps customers plan and execute data security assessments and technology implementation for healthcare. Our proprietary Technical Security Audit includes a personalized review of your IT systems and well as a vulnerability scan of all your network components.
On Wednesday, December 30th, the U.S Department of Health and Human Services (HHS) released its Interim Final Rule on Meaningful use. This rule is applicable to covered entities who chose to participate in the Medicare and Medicaid EHR Incentive Programs. Essentially, healthcare providers must prove that they are using the EHRs and meet HHS’s standards of meaningful use in order to receive reimbursement for implementing the EHR system.
Stages
Stage 1 (starting in 2011): Focused on electronically capturing health information, implementing clinical decision support tools to facilitate disease and medication management, and reporting clinical quality measures and public health information. Note that in this stage electronic protected health information (PHI) is being captured and stored, and as a result, must be secured. It is this specific information that must be protected from security breaches.
Stage 2 (starting in 2013):Focused on using captured information to improve care, electronic transmission of diagnostic test results, and computerized provider order entry (CPOE).
Stage 3 (starting in 2015): Focused on decision support and improvements in quality and safety.
Role of Security & Privacy in Meaningful Use
In general, HHS has specifically included encryption as a requirement for a Certified EHR system (only Certified EHR systems are eligible for cost reimbursement). The inclusion of encryption in meaningful use is indicative of the Federal government’s recognition that encryption is a critical technology in securing protected health information (PHI).
Certified EHRs must be able to provide the patient an electronic copy of their health information upon their request. This information must be provided within 96 hours from the time the provider obtains the information, such as lab results, for example. This patient information must secured with at least a symmetric 128 bit fixed-block cipher algorithm capable of using 128, 192, or 256 bit encryption key.
Certified EHRs must protect electronic health information by implementing controls and encyption, such as:
- Assigning a unique user name for each user
- Encrypt and decrypt health information for backups, removable media, etc.
- Event recording such as deletion of records
- Audit review log
- Systems to ensure health information has not been altered using a hash algorithm
- Record disclosures made for treatment
- Ensure identity management is in place
Systems outside of Certified EHRs
As a matter of policy HHS has decided NOT to dictate standards on privacy and security in the context of meaninful use for systems other than Certified EHRs. In other words, they acknowledge that there are other systems that are part of the electronic health IT ecosystem, such as backup systems, hard drives, removable media, domain name systems (DNS), time servers (NNTP), etc. They acknowledge that these systems should be protected. However, for the purposes of the scope of the ruling they decided not to dictate standards or requirements beyond those for the actual EHR system.
HHS took the time to reiterate that using a Certified EHR “does not change existing HIPAA Privacy Rule or Security Rule requirements, guarantee compliance with those requirements, or absolve an eligible professional, eligible hospital, or other health care provider who adopts Certified EHR Technology from having to comply with any applicable provision of the HIPAA Privacy or Security Rules.
This essentially means that you must still consider the security of systems outside the Certified EHR system and, if necessary, secure these systems. Implementing a Certified EHR system does not absolve your organization from the HIPAA Privacy and Security Rules. They go on further to say:
“While the capabilities provided by Certified EHR Technology may assist an eligible professional or eligible hospital in improving their technical safeguards in order to meet some or all of the HIPAA Security Rule’s requirements or influence their risk analysis, the use of Certified EHR Technology alone does not equate to compliance with the HIPAA Privacy or Security Rules.
Make sure you look at out healthcare IT system holistically. Implementing a Certified EHR is only part of the overall security equation in your organization.
If you intend on implementing electronic records and apply for the Electronic Health Record Incentive Program (EHRIP) you must demonstrate “meaningful use” of the electronic health record system. One of the provisions in EHRIP is information sharing. The authors of the EHRIP specifically set out to standardize on two protocols for information sharing:
Both of these technologies are know as web services. Essentially, web services provide information sharing capabilities using structured data files called XML. The purpose is to use these open standards so that applications developed by different vendors could communicate and share information.
Securing Web Services
In terms of security it is important to ensure that the transmission between applications using these web services is properly encrypted using SSL technology. In addition, considerations should be made to implement network and host intrusion prevention systems to ensure the security and integrity of the systems transmitting the shared information. For example, accepting SOAP requests will require you to set up a DMZ infrastructure. Servers sitting in the DMZ will need to accept SOAP requests and send them. It is the traffic to and from these servers, and the servers themselves, that need to be protected.
The Electronic Health Record Incentive Program spells out the proposed terms of the the reimbursements healthcare professionals and certain entities can receive by implementing electronic health records.
The Initial Set of Standards rule discusses the concept of “meaningful use”, which is a major component of the incentive program. Healthcare entities must meet certain requirements, like sharing of information and being able to capture specific information from patients.
Seems like it’s been a tough week for Verizon to try and prove their point about how encryption is unimportant to securing protected health information (PHI).
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According to ModernHealthcare.com Peter Tippett, Vice President of Technology and Innovation and Chief Medical Officer, recently said “Encryption of data at rest in a database, for example, typically provides “no value” against a large majority of hacking and malicious code threats, and “end-user devices like PCs, laptops and PDAs” are “orders of magnitude less important targets in the real world than is perceived (and databases are several orders of magnitude more important than end-user devices).”
In addition, Tippett says current security standards and methods are “too complex, are based on dogma instead of science, are both ineffective and inefficient, and are too static.”
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But facts and reality prove otherwise. The following RECENT breaches were revealed while Verizon is literally putting its head in the sand and marginalizing encryption (and all of them could have protected patient information had encryption been installed):
US Army loses hard drive with 60,000 with social security numbers and other personal information.
A laptop containing clinical information on 2,000 patients was stolen from the Guam Memorial Hospital.
And all this within 2 weeks! The fact is that data in use, like data at rest, and data in motion needs to be encrypted if it contains protected health information.
“On October 30, 2009, the Department of Health and Human Services (HHS) issued an interim final rule pertaining to the enforcement provisions of the HI-TECH Act. The final rule serves to conform HIPAA’s enforcement regulations to the revisions to the HIPAA statutes made by the HI-TECH Act.”
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This is the government’s way of saying “we’re made a rule, and we are now going to enforce it”. The enforcement ruling is an indicative of the federal government’s interest in protecting the privacy and identity of patients. As patient records get converted from paper to electronic security has become a very important part of the healthcare IT ecosystem.
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Bricker and Echler, LLC go on further to say “The HI-TECH Act significantly increased the penalty amounts for HIPAA violations, as reflected in the final rule. Covered entities should understand the financial risks associated with HIPAA non-compliance and the changes to the available affirmative defenses. It is critical to have an effective HIPAA compliance program to avoid HIPAA violations and to identify and correct HIPAA violations in a timely manner, which can shield the organization from substantial financial penalties”
In a strongly-worded letter sent and signed by six congressmen to HHS SecretaryKathleen Sebelius the message was clear: remove the harm assessment that lawmakers rejected when writing the privacy regulations into ARRA. The harm standard essentially says that in case of a breach the covered entity must make an assessment of whether or not the breach can cause reputational, financial, and other types of harm. This leaves open the possibility that a covered entity could decide to act in its own interest and make the decision not to follow the directives written into the breach notification ruling.
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There are, of course, two sides of the sword. On one hand it’s difficult to enforce a policy with subjective elements present, such as the harm assessment. It is unlikely that a covered entity would risk the substantial fines, now as high as $1.5 million, and the possibility of criminal prosecution to avoid notification in case a serious breach occurs. However, the harm assessment leaves that possibility open.
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A drawback to removing the harm assessment is that it is possible that, ironically, that too many breach notifications are sent to people, thereby creating a “boy that cries wolf” effect. In a perfect world breaches would never happen, so there would not need to be a reason to notify people. However, we all know that not to be the reality. Breaches do occur, intentional or not. And people need to be notified as soon as possible. Should covered entities be given the privilege of deciding the severity of the harm and potentially choosing not to notify people? We shall see the next steps Congress and HHS will take.
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- Encrypt and decrypt health information for backups, removable media, etc.
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