The Secretary has delayed enforcement of the Security Breach Rules to give covered entities and business associates a reasonable amount of time to come into compliance.  However, in anticipation of covered entities’ new reporting obligations, HHS on October 7th, released an online form (OMB No. 0990-0346) that appears to be the exclusive mechanism by which a covered entity can provide the required notice to the Secretary in the event of a security breach. (The form is available at http://transparency.cit.nih.gov/breach/index.cfm).  The form is intended only for security breach submissions by covered entities to the Secretary; breaches involving business associates must be reported directly to the Secretary by the affected covered entity and not by the business associate.

Analysis of OMB No. 0990-0346 – HHS’s Security Breach Reporting Form

The form itself offers some insight into HHS’s understanding of security breaches and how HHS believes breaches can be mitigated and/or avoided altogether.  The following are what I consider to be the most interesting questions and potential responses pre-populated within the form:

1. HHS has defined seven categories of breaches within the form: theft, loss, improper disposal, unauthorized access, hacking/IT incident, other, and unknown.  Theft, loss, and improper disposal are breaches that can be easily mitigated by encryption or by following the guidelines referenced by HHS for the destruction of paper/and electronic media;
2. The “locations” where a breach may occur, identified by HHS, include: laptops, desktops, network servers, e-mail, other portable electronic devices, electronic medical records, paper, and other.  Again this question and the pre-populated responses echo HHS’s interest in encryption for data stored on laptops, desktops, and other portable media devices.  Moreover, next to loss of PHI related to theft of computer equipment, e-mail runs a close second as the next biggest source of breaches involving PHI.  It is very easy for someone to mistakenly email a message to the wrong person;
3. The form identifies four categories of PHI–demographic information, financial information, clinical information and other.  Demographic information and especially financial information are high value targets to potential identity thieves; and
4. Probably the most interesting question, from a planning perspective, requires the covered entity identify whether any of the following security controls were in place before the security incident: firewalls, packet filtering (router based), secure browser sessions , strong authentication , encrypted wireless , physical security, logical access controls, anti-virus software, intrusion detection, and biometrics.

This list of security controls is an odd combination of specific types of security controls (e.g. packet filtering router) and general categories of security controls (e.g. physical/ logical access controls).  I find inclusion of biometrics and the exclusion of two factor authentication (a more general category) unusual – the utility of biometric access controls relate more generally to creating systems of two factor authentication.  Two factor authentication techniques are based on any two of the following three types of methods: something you know, something you are, and something you have.  One common example of two factor identification is the use of a security token that generates a seemingly random number in combination with a pin and a password to authenticate a user.  Biometric methods of identification, which include fingerprint scanners, facial recognition, and retinal scanners, are either too expensive to implement as a broad-based solution or are poor quality consumer oriented solutions.

In all, it is obvious what the hot button issues are that may get the enforcement body’s (Office of Civil Rights) attention and more importantly how to avoid them: (i) encrypting portable media, (ii) firewalls, (iii) proper document destruction procedures, (iii) the existence of a physical security plan, (iv) two factor authentication, and (v) antivirus.

The form should be filled out with diligence.  The form contains an attestation that the information provided is accurate, and acknowledgement that the Office of Civil Rights (“OCR”) may be required to release information provided via the form pursuant to the Freedom of Information Act, some of the information will be posted to HHS’s web site, and tOCR will use the information to provide an annual report to Congress required by the HITECH Act.