From time to time I'll send my clients and interested others an e-mail update on new or pending regulatory actions and news related to healthcare information privacy and security. I'll also post them here for others to read. If you'd like to be on the e-mail list, please contact me and I’ll be happy to add your e-mail address. Please remember, I am not a lawyer and this is not legal advice, it is only information and resources, and personal opinions. Thanks!
Welcome to my first newsletter in more than ten months. I dare say things have been busy in the world of healthcare information privacy and security regulatory compliance. Everyone is a bit scared that they’re already in trouble and don’t even know it. If the introduction of mobile technologies hasn’t created privacy and security issues enough, now the bad guys have finally woken up to the most poorly held secret in healthcare information privacy and security: if you want to steal someone’s identity to commit fraud, healthcare information is pure gold.
And of course that information is often used to commit health insurance fraud, which can affect the integrity of the patient’s record and present serious safety issues. On top of that, the complexity of health information handling and processing makes securing it nearly impossible. It’s just not getting any easier anytime soon. That’s why we love this work, right?
I’ll cover a few hot topics for you, and then get into some compliance questions and answers that I have received and provided over the last several months. Some of the best questions come from people who listen to a Webinar or seminar and have a particular wrinkle for which the answer is not immediately obvious. I can learn a lot from a new question, and many of you may have similar circumstances, so I’ll share a few in these newsletters. Not surprisingly, a lot of them have to do with communications, and with mobile devices and all the creative ways people use them, and their risks.
— HIPAA Changes —
••• As part of the executive branch implementation of federal gun control measures, on January 6, 2016, a new final rule was published to modify HIPAA §164.512, adding a new section (k)(7) to allow use or disclosure of PHI for purposes of reporting to the National Instant Criminal Background Check System the identity of an individual who is prohibited from possessing a firearm. The impact of this rule is limited to certain organizations, “only covered entities with lawful authority to make the adjudications or commitment decisions that make individuals subject to the Federal mental health prohibitor, or that serve as repositories of information for NICS reporting purposes.”
In other words, this is for the most part focused on government entities such as county courts, for instance. Disclosures may include only the limited demographic and certain other information needed for purposes of reporting to the NICS, and may not include diagnostic or clinical information. The new rule is available at: https://www.federalregister.gov/articles/2016/01/06/2015-33181/health-insurance-portability-and-accountability-act-hipaa-privacy-rule-and-the-national-instant
••• Speaking of changes, HHS has updated its Web site and it is much easier to use, much easier to find things on, more mobile-friendly, a huge improvement. But. In the process they’ve broken a lot of the links that led to many, many guidance documents and resources. I have looked through my links on the Resources pages of www.lewiscreeksystems.com and fixed dozens, and I keep checking them in my presentation and handouts, so I think I have them pretty well nailed down on my end, but if you find any faulty ones, please let me know. If you have older materials with now-broken links, you can find the new ones on my resources pages at http://www.lewiscreeksystems.com/resources.html or you can try fixing it by inserting "/sites/default/files" right after "hhs.gov", which works most of the time.
— HIPAA Guidance —
••• If you’re looking for guidance (and couldn't we ALL stand a little guidance these days?), one link that sure does work, and ain’t it grand, is for the new guidance from the HHS Office for Civil Rights on individuals’ rights to access their health information. The guidance includes general information and specifics about the details of proper implementation, and also includes an extensive Q&A section providing additional information. If this guidance is an indication of the quality of information we should expect from HHS on the Web, it’s a good sign.
The guidance is clear, well written, and well organized, and directly addresses one of the issues that has been consistently identified as a weakness in HIPAA compliance: patient access of records. The regulation is presented in detail and the Q&A section addresses many of the questions I have gotten from all of you. Providing access properly, and handling denials of access properly, have been identified by HHS enforcement leadership as an area where it is time for there to be better compliance, so we can expect to see this as a target issue in the upcoming round of HIPAA audits, expected “real soon now."
If you have questions on providing access under HIPAA, look here first. http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html If you don’t have questions, look it over anyway, and you may learn an important detail relevant to you. Are you prepared to handle denials of access properly? Make that your HIPAA compliance task of the week, and document it to show your consideration of compliance. See? Wasn’t that easy?
••• A little trickier is the work needed if you want to actually de-identify data for one purpose or another. The question is often, “what if I de-identify the data?” Well, what does that mean? Sure you can remove all 18 identifiers listed in the regulation, but context still remains, and context can reveal a lot about the identity associated with a piece of data. While the ultimate answer is far from always clear, NIST has announced a report on De-Identification of Personal Information, NIST Internal Report 8053.
The report summarizes two decades of de-identification research, discusses current practices, and presents opportunities for future research, including discussion of HIPAA methods for de-identification, and the effectiveness of the HIPAA Safe Harbor method. The report is available at http://nvlpubs.nist.gov/nistpubs/ir/2015/NIST.IR.8053.pdf If you are dealing with any issues of de-identifying PHI, READ THIS REPORT! Also, see HHS’s guidance from 2012 on De-identification of PHI, available at: http://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/understanding/coveredentities/De-identification/hhs_deid_guidance.pdf (And yes, I fixed that link.)
••• If you’re thinking about how your mobile device connects to your cloud-based EHR (and let’s face it, isn’t just EVERYbody these days?) best to take a look at the first industry specific special publication in draft from NIST in SP 1800-1, focusing on the use of mobile devices in health care. The idea is, use multiple layers of security in controlling access (a.k.a. strong authentication), and ask your EHR vendor some hard questions — a good questionnaire is included in part “e” of the guidance. With the alarming increase in the number of breaches by hacking, caution is indicated. https://nccoe.nist.gov/projects/use_cases/health_it/ehr_on_mobile_devices
— Q&A —
Here is a question I get frequently in one variation or another, and my reply, regarding texting with patients.
Question: Are offices allowing their clinical and/or front desk staff to text with patients? We want to allow our providers to text for scheduling and location purposes. All of our patients are homeless or recently rehoused and sometimes they go off the radar. They tell our providers, nurses, case managers over and over again "Just text me - I ran out of minutes." So they are asking for this form of communication. We're a small practice and want to make sure we aren't doing anything "crazy" if we start allowing texting.
Answer: The short answer is yes you can use texting, but you need to be prepared to handle it properly as a communication medium. That is, you need to be sure you document any text exchanges that could be considered part of the record, just as you would any communication. And you need to be ready to deal with people wanting to text 24/7, and the proper handling of those.
The idea is, the Security Rule requires you to consider encryption of all transmissions, but doesn’t outright require encryption. When you do the risk analysis, you see that you really should encrypt all communications like e-mail and texting that contain any PHI, because the information is not secured and could be exposed, and that would be a breach. For business communications involving PHI, yes, encryption is basically necessary.
But when it comes to communication with patients/clients, they have certain rights under the Privacy Rule to communicate in the way they see fit so long as you can reasonably do that. The guidance says, if they want to use insecure e-mail (and by extension, texting), let them know that it is not a secure communication and it could be exposed, and if they want to go ahead, you can. It’s a good idea to document their consent to use an insecure method, either through having a good process, or getting a signature, or both.
And that gets us back to the issue I mentioned at the top, that you need to be prepared to handle it properly. Always have a secure, documented method of communication you can start from, and then allow insecure ones as necessary to provide services, with consent. If it’s more than you feel you can handle, you don’t need to do it. But if you want to, you can; just explain the risks and get a consent to do so, and document your exchanges.
Here is a question on texting of reminders of appointments, which is a growing practice.
Question: We [a dental office] periodically text appointment reminders to our patients using a web based text system. We do NOT include their names in the text, just the day and time of their appointment. Is this OK? If we were to move to texting phi in the future, how do we do this securely?
Answer: This is one of those gray areas. The phone number can be an identifier, so it depends on the detail in the reminder. If you don’t explicitly identify the organization, but use its initials, you’d be better off than if you used the entity name, which could provide some information about the kind of services being provided. Of course, a dental appointment is not the same as an appointment for cancer treatment or reproductive health, so the actual risk of a real issue is small [for a dental office].
Nonetheless, I would also secure consent from the individuals to send reminders by text message, advising them of the insecurity of text messages. Even if you have consent, keep the content to a minimum and as de-identified as you can. [The most secure reminders do not identify the office or the nature of the appointment, they come from a reminder company and only say for what time the appointment is scheduled.] The consent doesn’t need to be terribly complicated, but should be documented somehow.
Also, take a moment to document your accepted practices for this, so you can help prevent the use of texting for other purposes that you haven’t protected.
And finally, a question on Business Associates and Risk Analysis.
Question: My concern is getting business associates to comply with doing a risk analysis. How have you seen other CE’s do this? Also, if there is a breach by a business associate, would HHS hold the CE or the business associate accountable? Or both?
Answer: CE’s are beginning with making sure they have the right kind of a BAA in place first, and that calls for the BA to be in compliance with the HIPAA rules, including the Security Rule, which requires a risk analysis. You need to feel sure that the BA is in compliance, which ties into your second question. If you feel you have assurances that the BA is in compliance (which begins with the BAA, but doesn’t necessarily end there), chances are that any breach will be their responsibility. But if you don’t have sufficient assurances that they’re meeting the requirements in their BAA, you could also be held liable for breaches — the new rule doesn’t let you off the hook entirely.
This is a very difficult situation, as there are many BA relationships in which the BA does not realize what they’re signing when they sign a BAA with the CE.
While the entirety of the security rule applies, the place to begin is for them to do a risk analysis and make sure they have breach notification policies and procedures. I suggest you let them know that they need to follow the rules according to the regulations and the BAA, and that they have a period of time (60-90 days) within which to provide you some kind of documentation that they have actually done something to be in compliance with the rules. You’d like to see a summary of their risk analysis report or the table of contents to their HIPAA policies, things like that.
This will take time, but it is being tackled, slowly, by the industry. [You can also ask to see a third-party evaluation such as an SSAE 16 SOC Type 1 or 2 Report, or submit a questionnaire similar to that presented by NIST in their draft guidance in SP 1800-1 part e, available at: https://nccoe.nist.gov/projects/use_cases/health_it/ehr_on_mobile_devices ]
I wish it was easier, but with the high profile breaches these days on the increase in health care, these are good things to do.
I have a lot more questions I can answer, but this is a start, and I hope to get to the next newsletter in something less than ten months so I’ll save some. I also hope to get the next one out using a modern newsletter management platform, so expect to see a different look and feel, but the same attitude inside.
This is a time of change in HIPAA and a change in the privacy and security landscape the likes of which we’re not likely to fully comprehend for some time. It’s a good time to keep your eyes open and look for ways to protect privacy and security before you discover you haven’t.
I don’t want to turn this into a promotional newsletter, but my mission is to make HIPAA easier for the world, so I have to mention that I have several Webinars and seminars scheduled around the country coming up — check in at http://www.lewiscreeksystems.com/upcoming_public_seminars.html And I’m working on a book on the "10 Day HIPAA Compliance Plan," for which I have been asked by many, and which I hope to have completed in the next few months. Would it be of interest to you? Something to answer the question, “Yeah Jim, but where do I start and what do I actually do?” Would you prefer a hard copy or electronic or both?
And of course, if you have any questions for me in the meantime, I always learn as much from you as you do from me, so please let me know.
— HHS Updates “Wall of Shame” Web page — Now on the new HHS OCR Portal —
The calendar says it’s spring, but today has a forecast of below zero wind chill and the lawn furniture is solidly frozen into the ground. Don’t even think of trying to get that last row of firewood off of the ground — it’s not going anywhere until when, May? I think we’ve all stopped hoping for warm weather, yet we dream…
Well, time to snap out of it, because there are indeed signs of Spring over at the HHS Office for Civil Rights, in the form of the new HIPAA Breach Notification “Wall of Shame” Web page for larger breaches, now located at https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf . The new page is designed well, using modern, secure technology, and offers a huge variety of search and analysis options, built-in. You can click on any entry and get more details, sort, and export the data to Excel, PDF, CSV, and XML formats. Click on the “Show Advanced Options” link and you’ll have access to powerful searching and sorting capabilities, so you can see for yourself what kind of issues are prevalent at what kind of entity, over what time period, for instance.
But that’s not the only story here. In addition to the vastly improved Wall of Shame, you’ll note that the page is located in the new ocrportal.hhs.gov domain, which will host the communications and data submissions for the revived HIPAA Audit Program. As you may know, HHS OCR is eager to get under way with the new HIPAA Audit Program for 2014 — oops! — now 2015, and they’ve been waiting to get the new portal set up to handle the process for the hundreds of desk audits that will take place. So, while I long ago gave up on trying to crystal ball any predictions of when certain activities or regulations would be forthcoming from HHS, this new site does indicate that HHS OCR is moving forward and that the mystical, mythical new portal has appeared. How long before they get started on Audits? Who knows, not me, but there are signs of life. Signs of Spring.
— NIST Relocates link to SP 800-61 rev 2, Computer Security Incident Handling Guide —
While we’re on the topic of new links, here’s a new one for the eminently useful NIST Special Publication 800-61 revision 2. http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-61r2.pdf If you have some kind of a security incident and HHS wants to ask any questions, they’ll want to see your incident report. You know, the one you’ll create to describe the incident handling process you used to determine the facts and the right course of action to take. You do have such a process, don’t you? Well, I know many of you don’t have much of a process, but this publication from NIST is accessible, useful, and well-founded. While you’re updating your bookmark for this, take a look through and see what you can do to beef up your incident handling.
— Speaking of Beefing Up Security —
So, is it clear now that health information has become a very real target? And please, don’t let the hackers roam around in your networks for most of a year before you discover it. You really do need to apply the resources to actively monitor your network health; the only way you’ll see the bad guys these days is if you notice any anomalies in your traffic and system use, and that requires a consistent effort involving the establishment and fine tuning of monitoring tools and processes.
— And Backups? Do you know how you’d recover from the loss of your data center? —
So, did you hear about that hospital in California that lost its EHR for a week after an air conditioner died at the data center? One cooling unit went down, then the other overheated trying to keep up, and it died too. And so did the hospital’s EHR system. And oh sure, everyone went back to using the paper processes and life went on as normal. No?
Here’s the problem, and I’ve seen it, and it makes me worry. In the olden days, a hospital’s EHR was a relatively simple thing (compared to today) and it took resources to operate it that would seem almost trivial today, such that it was reasonable for a hospital to keep nearby the systems, backups, and capacity to quickly recover from any outages. But, as the newer systems go in, what once would run on a few boxes now requires a dozen or two, and the amount of data being managed has exploded, such that many hospitals don’t have the robustness needed for recovery from the loss of a data center’s worth of equipment.
I think this recent example may send a wake up call to the facilities in similar situations — either you get what you need in place to reasonably recover without making national news, or you look at having it hosted in the cloud, not that that’s exempt from availability issues either. No matter what, and with inadequate Contingency Planning identified as a leading issue in the 2012 HIPAA Audits, we are more wedded to our EHRs than ever before, and need to put some serious thinking into making sure that disaster recovery really will work.
— Cell Phones and Texting —
Face it. You can’t deny it any longer. Texting is happening and you can’t stop it. You’d better say in your policies how texting may or may not be used, and how. If you need it for casual intra-office communications, get one of the free secure texting apps, like Cortext from Imprivata, or TigerText, or DocHalo. If you need it to communicate with your patients, use one of the new texting tools that provide integration with your EHR, team-based communication management, and security, like the system from OhMD.com (no financial interest in them, but they’re a client of mine and I provided them guidance on HIPAA, and they’re local).
But most of all, don’t try to deny the devices are being used — manage them! And don’t forget the end-of-term issues. What happens when someone turns in their old phone full of PHI, for a new one? Even if you have it managed well, once it’s been turned in you can’t remotely wipe it and there it may be, loaded with PHI, out of your hands. People need to know about this before they decide a nice shiny new Android or iPhone 6 is essential to their happiness. Manage, inform, train, and audit. Back to the basics.
— And before I forget… (Department of Shameless Self-Promotion) —
Be sure to check out my list of upcoming Webinars and seminars. I know many of you are your organizations' key HIPAA compliance specialists, and if you are, I know folks really enjoy my two-day HIPAA A to Z sessions, and I really love teaching them. My next 2-day session is in Baltimore, Maryland, April 16 and 17, and I’d love to see any of my clients or former students there. Yes, HIPAA can be fun! See the whole list of sessions at http://www.lewiscreeksystems.com/upcoming_public_seminars.html and sign up for my 2-day session at https://www.globalcompliancepanel.com/control/globalseminars/~product_id=900187SEMINAR You will learn a TON about HIPAA.
So, stay warm and keep your snow shovel nearby! Maybe my next newsletter will be when it’s actually warm outside…
— Encrypting Medical Records Sent On Electronic Media —
One of the most frequent questions I hear these days involves sending out medical records that used to go out in the mail on hard copy, but now go on electronic media, such as flash drives or CDs. In the old days you’d just put the records in the envelope and hope for the best. If you can do that, why would you need to encrypt electronic media? It wouldn’t be any less secure than the paper. But the Security Rule most certainly includes provisions about encryption of electronic PHI, so what should you do?
There is not a strict requirement to encrypt anything, but there are requirements to consider encryption of any PHI at rest and in motion. One of the most common ways for PHI breaches to occur involves records that are sent and are misdirected or the packaging becomes compromised. There isn't much you can do with hard copy records other than check addresses and use strong packaging, but a risk assessment of electronic PHI would probably indicate that encrypting records sent on a CD or other electronic medium is a very good idea, because it eliminates the most common cause of breaches, which can be expensive to respond to and lead to enforcement investigations.
In fact, organizations that haven’t adequately considered encryption of data at rest on portable media wind up with some of the biggest HIPAA fines that have been handed out, and risk analysis for encryption of data at rest on portable media is a target area for meaningful use attestation in stage 2. It’s also expected to be a topic in the 2015 random HIPAA audits.
So, while there is no strict requirement to encrypt, any reasonable risk analysis would indicate that you’d be nuts not to encrypt for professional communications. It is extremely do-able today with minimal effort and cost, and there are severe consequences if you don’t and something goes wrong.
When it comes to sending records to the patients, though, they do have a right to ask that you send the media unencrypted so they don’t have to deal with passwords. You should have a plan to accommodate unencrypted records the same way you would a request to communicate via plain e-mail — explain the risks (which also depend on the amount of information and level of detail), ask if they want to do it anyway, and document their assent if that’s what they want.
But it’s certainly a good idea to have the default behavior be to send records encrypted. As part of a dialogue about a records release, you may wish to inform your patients that the records will be sent encrypted with the password sent separately, and if they object, let them know they can get them unencrypted, with the explanation of risks and their approval.
For professional communications, such as between provider offices, encryption is the standard of care for electronic PHI, without question.
— New NIST Draft SP 800-171 Provides Excellent Summary of Security —
On November 20, 2015, the National Institute of Standards and Technology released the first public draft of SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations, which provides an excellent summary of security actions to take to protect information systems, and provides a great checklist of security considerations. I recommend every HIPAA Security Officer review this remarkably compact and useful draft document. It can help every organization working to secure its information systems, without overwhelming anyone. It is clear, easy to use, and fully digestible. To view the full announcement and link to the draft document, visit the CSRC Drafts page at: http://csrc.nist.gov/publications/PubsDrafts.html#800-171
The draft is open for comments until January 16, 2015, and I encourage anyone who does have comments to be sure to pass them on, because information received during the comment period can have a tremendous impact in the usefulness of new documents. If you would like to submit comments on the draft, you can Email your comments by January 16 to: firstname.lastname@example.org
In my estimation, any Health IT shop that fully addresses NIST SP 800-171 and the SANS Top 20 Critical Security Controls ( https://www.sans.org/critical-security-controls/ ) would be one of the more secure Health IT operations in the country. It’s good to have decent tools to help you prioritize and provide the best protection you can with the resources you have available.
— Heads Down, Back To The Holidays! —
Egad! December? 2015 around the corner? I’ve already started scheduling seminars and Webinars into next June, no less! (See: http://www.lewiscreeksystems.com/upcoming_public_seminars.html ) I suppose we all have way too much work to do already so I’ll keep this short, and wish you a happy holiday season!
– No Magic Bullet for Compliance? –
Goodness – I haven’t written one of these since last February, and I guess that’s partly because I’ve been busy, but also partly because the world keeps changing and the issues along with it. In the meantime, HIPAA compliance doesn’t go away, and the threats keep on coming. I haven’t seen a magic HIPAA compliance bullet yet, but there are some things you can do to help reduce your compliance exposure, even if they may not be something you can accomplish right away.
Using a highly integrated, cloud-based infrastructure for your medical records system is one thing I’ve seen that helps eliminate points of risk, so long as it is implemented correctly and includes sufficient protections for continued operations when connectivity goes out. Having all the access, management, and communication of your PHI take place within a system that keeps persistent data off of remote devices and simplifies operation (which prevents issues) avoids many of the security weaknesses that plague modern health IT. Not only that, but by essentially outsourcing a good portion of your backup and restoration operations, you are releasing time that can be used for other essential activities, such as new projects and government mandates, and good old security monitoring.
Of course, you want to be sure any contracts provide for access to patient records no matter what contract disputes arise (which would be necessary to meet Privacy Rule requirements for Business Associate contracts), due your due diligence with the vendor, and speak with your peers using the same system to find out about the gotchas before they getcha.
– Speaking of Monitoring… –
Probably one of the most painful and widespread issues I see as I visit health care organizations from Maine to California, from Florida to Alaska, is that organizations have not done what’s necessary to audit and review the access and use of PHI in their systems.
The Privacy Rule still has its basic Minimum Necessary foundation in place, and entities have an obligation to make sure only the right access is taking place. The Security Rule calls for both the technical ability to track accesses of electronic information, and the administrative process to regularly review access lists and logs to determine if policies are being followed.
One of the top security-related issues identified in the post mortem of the 2012 HIPAA Audit Program is that these internal audits and reviews have not been taking place. Why? Because they are a pain to do, and require not just an IT review, but some kind of evaluation of the access that has taken place to see if it is appropriate or not, and it may not be easy to determine without the involvement of overworked managers for whom HIPAA compliance is a burr in the saddle.
And it’s not going to be getting any easier soon. One of the recommendations from the team that examined how to implement the HITECH Act changes required for Accounting of Disclosures is to modify the Security Rule and enhance requirements for the ability to record details of who accessed what information and when, so that more accurate Accountings to be provided, and auditing ability is enhanced. Here is a link to a great set of slides from the team about Accounting of Disclosures and the latest proposals (provided in my last newsletter as well): http://www.healthit.gov/FACAS/sites/faca/files/HITPC_PSTT_Accounting%20of%20Disclosures_FINAL_12042013.pdf
So how do you look at access of records? In a small organization it may be reasonable to look at a week’s worth of access logs for all users and see if there is any unreasonable access. If you don’t find any problems, look again in a few months, and if you’re lucky, you can just keep checking on a quarterly or semi-annual basis. If you do find problems, you need to deal with the issues and keep a tight focus on the issues until you’re sure they’re resolved.
For a larger organization, take some samples of staff and some samples of patients over a period of time, to see if all the accesses look right. If you take a good sample you won’t annoy everyone on staff at once, and if you don’t see any issues, you’re in pretty good shape, just keep checking periodically. But if you do find issues, you need to look deeper and wider until you feel you have a handle on it.
And this is important why? Because this is a well-identified issue from prior audits and it will likely be a target question once they get those HIPAA Audits rolling again. Of course, this also is tied to doing regular security audits to ensure your systems haven’t been hacked, and what it all really points to is a need to establish your Information Security Management Calendar that schedules your regular reviews and audits so that you can show what you have done and what you are planning to do, if you are asked any questions about it.
– And what about those HIPAA Audits? –
So, will they ever reappear? They’ve been discussed and hyped and planned for, and now, guess what? We’re waiting for HHS to finish the Web portal that will be used for exchanging information in the new audit process. Yes, the very same HHS that has such a good reputation for quality, timeliness, and security in its Web sites (OK, I really can’t kid about this) hasn’t been able to finish the portal, so the whole HIPAA Audit process is on hold.
The good news is that you have more time to deal with other top issues before they start up again, Real Soon Now (that’s a term from the software development world). You might take a look at another access-related issue, access of patient information by individuals, family, and representatives, and the handling of denials of access, which is identified as a top Privacy compliance issue in the 2012 Audits.
– Patient Access, that’s simple, right? –
Apparently not so much. This is an area that trips up many providers and is one of the areas of most frequently asked questions that I get. You probably have some policies about providing access and how you handle denying access that were put in place in 2003 and haven’t been looked at since then. Go dig them out and see what they say. They at least need to be updated for the Omnibus updates of 2013.
A few pointers: If someone wants a copy of their records including the records received from another provider that you used to make decisions about the individual, you need to provide all of that. Individuals have a right to know what you were looking at when you made decisions about their care, with a few exceptions, such as for psychotherapy notes, disclosures that could cause harm to the individual or others, or disclosures that would reveal the source of information given in confidence (not from another provider).
Note that individuals now have the right to access their laboratory test results directly from the laboratories, as well as new rights to get electronic copies of information held electronically. Also, there is no longer an automatic extra 30-day allowance for provision of records held offsite. In addition, changes to the Privacy Rule allow personal representatives and family members the same access to a deceased patient’s PHI they had prior to death, to help preserve continuity of communication and care for the family.
But more importantly, make sure you have the proper processes in place for making acceptance or denial decisions for requests for access, and for having the proper denial appeal process in place for the denials that may be appealed. I won’t go into all the details here, because there are many, but suffice it to say that improper handling of access requests and denials has been identified as a 2012 Audit issue, so you would be well advised to make sure you have the proper policies in place and people know what they are. We are dealing with one of the foremost rights of individuals under HIPAA and one that people complain about when they feel their rights have not been satisfied. Mishandle requests for access at your peril.
And I haven’t even discussed patient access and communication using e-mail and texting, which could take a few paragraphs more than you can stand to read right now
Here are some links to recent (since my last newsletter) guidance on access issues:
• Guidance on mental health information and circumstances the Privacy Rule permits health care providers to communicate with patients' family members and others to enhance treatment and assure safety: http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/mhguidance.html
• Guidance clarifying that same-sex spouses are have the same HIPAA rights as other family members, no matter where services are provided: http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/samesexmarriage/index.html
– But don’t worry, I’m never far away –
There is so much to consider under HIPAA these days, and the issues will only be growing. I cover a lot of what you need to know in my Webinars and seminars. Come see me next week (October 30 and 31) in Raleigh, NC for one of my highly acclaimed two-day soup-to-nuts in-person sessions, or any of my upcoming sessions. Here’s the latest in my schedule: http://www.lewiscreeksystems.com/upcoming_public_seminars.html or http://tinyurl.com/a5gplbr
— Talk About Busy —
Well, as anyone in HIPAA compliance will tell you, it has been a very busy period since my last missive, way back in May, no less. The Omnibus compliance deadline of September 23 has come and gone, and the sun still comes up in the morning, well usually, anyway, unless it’s obscured by the latest winter storm. But the good thing is that the sense of panic is giving out, being replaced by an increase of interest in just plain getting down to work and slaying the HIPAA dragon. And the good thing for me about this latest winter storm is that it has disrupted my travel plans and allowed me to actually take a few moments to compose an Occasional Client Update Newsletter. And there is most certainly plenty too talk about! I won’t cover everything that’s happened since last May — you can see all that on my News page, at http://www.lewiscreeksystems.com/privacy_security_and_compli.html — but here are some important highlights.
— Accounting of Disclosures Rears Its Ugly Head —
Well, I think I was a little critical in my prior discussions of the proposed new Accounting of Disclosures rule, and I guess I wasn’t the only one. The proposed rule has been stopped in its tracks, and in the meantime, HHS gathered a US Department of Health and Human Services Office of the National Coordinator for Health IT Health IT Policy Committee Privacy and Security Tiger Team (the USDHHS-ONCHIT-HITPC-PSTT?) that released a report with its recommendations on the topic, available as a PDF of slides, at http://www.healthit.gov/FACAS/sites/faca/files/HITPC_PSTT_Accounting%20of%20Disclosures_FINAL_12042013.pdf or http://tinyurl.com/lhym4qh
The recommendations call for a staged implementation relying on available technologies, with pilot projects, an accounting of disclosures outside the organization from certified EHRs as the first step, a new right to request an investigation of internal access, and recommendations to expand the Security Rule to call for more detailed ability to log access for auditing. Simplifying the question of how to distinguish between uses or disclosures at hospitals by community physicians (in the hospital or from their office), the proposal calls for all such accesses to be treated as disclosures. Compared with the proposed rule, the recommendations are more reasonable, more implementable, and more likely to satisfy the desires of patients.
My guess, and we all know how incredibly accurate my guesses are (not!), is that these recommendations will come out as an Interim Final Rule this year at some point, so be ready to hear about it, but don’t panic, as it shouldn’t be too bad. (Famous last words…)
— New Changes for Lab Access —
OK, so who here thinks it’s a good idea for patients to get their lab results without any consultation or interpretation from their doctor? Not many hands going up… But who here thinks a patient should have a right to have direct access to the information so they can develop their own personal health record? More hands up, I’d suspect.
So, that’s the deal in the new final rule, being published February 6, in effect April 7 and Enforceable October 4, 2014, that allows access of authenticated lab results by authenticated individuals or their authorized representatives under HIPAA. (That’s a lot of “auth…” words in one sentence.) Patients will still be able to get their results, with interpretation and counseling, from their care provider, and providers will still have access to the information for treatment. The change simply allows the individual to ask the lab directly for a copy.
Of course, “simple” is in the eye of the beholder — for the laboratories that must now establish a public-facing operation where there was none before, this is not simple at all, and will require the development of new policies and procedures. And updated Notices of Privacy Practices. As usual, it’s worth taking the time to read through the Preamble for all the insights into HHS thinking.
— Proposed Changes for Reporting to Background Check Database —
Along with recommended new rules and new final rules, of course we have a proposed rule, this one to allow freer flow of information from healthcare providers into the National Instant Criminal Background Check System (sounds Orwellian, eh?), permitting certain HIPAA-covered entities to disclose to the NICS the identities of people prohibited by federal law from possessing or receiving a firearm for mental health reasons. HIPAA has ALWAYS had a provision for the disclosure of PHI in the event of a threat to health or safety, but this would clarify what information and how it should be disclosed.
This one is not a final rule, so there is no action to take now, but you should be aware that it may require some modifications to your HIPAA policies once it is finalized. When? Oh dear, I don’t want to guess… Maybe this year? We’ll see. Here’s the proposed rule, so you can see what’s being considered: http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/NICS/index.html or http://tinyurl.com/m6xpnwx
— New Settlement for Stolen Data Stick and Lack of Breach Policies —
Have I mentioned before that it is important to encrypt portable devices such as memory sticks? APDerm, a provider with six offices in New Hampshire and Massachusetts found out the hard way by losing one of theirs and not having it encrypted. Breach time! And when you do have a breach, what do you do? You follow your incident management policies and procedures to see if it’s reportable, and follow through on your established process. What’s that you say? You don’t have policies and procedures sufficient to meet the HIPAA Breach Notification Rule requirements? You might be next in line for a $150,000 settlement and a Corrective Action Plan. APDerm apparently didn’t have written down what they should have.
Time now to dust off your Breach Notification policies and procedures and make sure you can do what’s necessary when the time comes. And if you don’t like what you find, check out the NIST Special Publication on Computer Security Incident Management, SP 800-61, Revision 2, at: http://csrc.nist.gov/publications/nistpubs/800-61rev2/SP800-61rev2.pdf or http://tinyurl.com/8ouxxsn . In addition, see the September 2012 NIST ITL Bulletin for additional insights and guidance, at: http://csrc.nist.gov/publications/nistbul/itlbul2012_09.pdf or http://tinyurl.com/kx5empm
Oh, and did I mention that the HHS Office of Inspector General wants OCR to get off their butts and get busy with some real audits and enforcement? I just love the title of the report — it says it all: "The Office for Civil Rights Did Not Meet All Federal Requirements in Its Oversight and Enforcement of the Health Insurance Portability and Accountability Act Security Rule” Yes, but what did they really think? See: http://oig.hhs.gov/oas/reports/region4/41105025.pdf or http://tinyurl.com/pj55cnr . Time to get ready for a HIPAA audit, I’d say.
— Speaking of Enforcement, Say Hello to the FTC —
And if that wasn’t enough, now the Federal Trade Commission says that just being a HIPAA Covered Entity doesn’t get you out of obligations under the Deceptive Trade laws that FTC so artfully uses to go after those who allow breaches of personal information. If you say you will protect someone’s personal information and then you don’t, that’s a deceptive practice and the FTC will make your future a gray one if they decide to go after you, which they can, whether HHS is interested or not. I’d guess that as a matter of practice FTC won’t step in if they feel HHS OCR is doing their job, but, well, see the OIG report on OCR in the paragraph above. Here’s a link to a Bloomberg News story on the order: http://www.bna.com/ftc-affirms-data-n17179881620/
— It’s February 4 - do you know where your small breach reports are? —
And finally, don’t forget that we’re in that magical time before March 1, that 60 days within the end of each year when you must all report all your small breaches (under 500 individuals affected) to HHS, using their Web site, at: http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/ or http://tinyurl.com/3z3bj4y . Of course, you do have a breach reporting policy and procedure, don’t you? (Is there an echo in here?)
So, Happy HIPAA to all, and let me know if you have any questions. Also, see the latest in my schedule of upcoming seminars and Webinars. http://www.lewiscreeksystems.com/upcoming_public_seminars.html or http://tinyurl.com/a5gplbr . Soon to be added are 2-day HIPAA sessions in Sao Paulo, Brazil (!) and Toronto, Canada in March, as well as other sessions. At least I’m not doing Brazil and Canada in the same week — how would I pack for that?...
-- Enforcement Panic --
OK, so none of us really has much time, what with the summer now upon us and a September 23, 2013 compliance deadline for the new HIPAA rules, but I figured I'd better pass along a few nuggets gleaned from the annual NIST-OCR HIPAA Security Conference, held last week in Washington, DC. With apologies to Douglas Adams and the Hitchhiker's Guide to the Galaxy, DON'T PANIC! In large capital letters.
Leon Rodriguez, head honcho at the HHS Office for Civil Rights arranged to have a nice new violation settlement announced after the end of the first day of the conference, so he'd have plenty to discuss in his opening session on day two. But the real gem in his commentary is not so much about that particular incident, but about their approach to enforcement in general, which is, if you're being a fool and refuse to deal with obvious problems, you're going to get in trouble with OCR. The other side of that is that OCR is not going after organizations that make simple mistakes. If a doctor makes a bad judgement call and passes along information he shouldn't have, nobody's going to jail or getting a penalty. Just that you even seriously considered HIPAA is something that makes them happy. They're not fussy about what kind of encryption you use -- just that you have considered it and are doing ANYTHING puts you in good stead.
Where they get cranky is when you ignore the rules and ignore known issues. Considering the rules and making a bad call is a chance to learn, not cause to be penalized. And for goodness sake, don't let HIPAA get in the way of what you think is reasonable and appropriate. Don't over-think it and unreasonably restrict reasonable disclosures. Rule #1 -- do what the patient wants you to -- "the patient is at the top of the pyramid", and Rule #2 -- there are big exceptions when the health or safety of the patient or others is at risk -- "HIPAA is a valve, not a block."
So, do a risk analysis, consider the clear and obvious issues like laptops and paper records, and update the risk analysis when you change how you do business -- compliance is a process. Folks, I am not making this up -- I am paraphrasing Rodriguez's words, and they echo my longtime advice. Enforcement is not based on one bad decision on one bad day, it's based on the systemic violation of sets of rules.
Oh, and as for that settlement? Be sure you check the security configuration of your servers and systems upon installation and regularly thereafter, and don't leave things vulnerable for months at a time.
-- Cloud Vendors, Conduits, and Persistence of Custody, Oh My! --
Hey, hey, hey, now, enough of the Wizard of Oz references -- that was the last newsletter. (But why are the monkeys still flying around?)
So, there were some important insights into the as-yet-unresolved question of whether Amazon will need to start signing BA Agreements if it wants to continue serving health information clients with its Amazon Web Services products. And, of course, it's not just Amazon, it's any "cloud" vendor handling PHI. The thinking used to be, if it's encrypted and they don't have a key and can't access unencrypted PHI, they're not a BA. Like a landlord relationship -- they're not responsible for your stuff, they're just renting you space and you have to secure it.
But the new rules challenge that notion. The new rules say anyone acting on behalf of a CE that receives, transmits, creates, or maintains PHI is a Business Associate. "Cloud" vendors like "Box" and Verizon are indeed willing to sign BA Agreements and will start siphoning off AWS clients. Will Amazon be able to resist the tide of BAA requests and the inevitable defections to providers that will sign a BAA?
"Persistence of Custody" has emerged as the key phrase. HHS now has this issue under review, and I would expect there to be some kind of official guidance on the topic issued someday, hopefully before it becomes a dead issue. (And if you think I'll hazard a guess as to when, you've got another think coming!) The thinking is, if there is persistent custody of PHI, a BA is warranted, even if the PHI is encrypted.
There is a very limited exception for Conduits, such as the postal service, FedEx, or an ISP that simply provides transmission capability. In the Conduit model, there is no persistence of PHI -- it's passed off and no longer in the courier's hands. But that's not so clear when it comes to electronic delivery. Often a copy remains and can remain on backups indefinitely. A conduit is a pipe, not an opaque bucket.
And don't forget security includes availability as well as confidentiality and integrity, so if your cloud vendor is responsible for ensuring good backups of essential health information and resilience in the face of disasters or "events", they're performing an essential service for your security compliance, helping to preserve your data, so they really should be under some kind of a BA agreement anyway. They would, indeed, clearly, be responsible for aspects of the "maintenance" of your PHI. Sounds like a BA to me.
-- And the Compliance Issue of the Day Is... --
Well, it could be laptops and portable data, since those breaches are still being reported almost daily, but that would be too easy. Let's take a lesson from the kind folks at OCR who were nice enough to do their latest enforcement thing on Idaho State University and not you, so you can learn from their mistakes. What happened there? Nobody checked to make sure some servers were properly secured upon installation and regularly thereafter, and an insecure server allowed uncontrolled access to more than 17K patient records for nearly a year.
The lesson? Make sure your technical people follow good practices whenever new equipment and systems are installed, and have a security check done regularly -- there are even tools that can do a lot of this for you if you just set them up right. Let's all say the words together now, it's just eight syllables, "reg-u-lar tech-ni-cal re-views." I'd put money on the audits that start in October having some questions on this topic, so get started now with some good, regular, documented practices that can go a long way toward protecting you from breaches.
-- Your Mantra Is, Repeat After Me... --
Risk Analysis, Encryption, and Regular Reviews. Like the nice Mr. Rodriguez says, compliance is a process. Risk Analysis, Encryption, and Regular Reviews. If you can document these and keep them up to date, you're on top of the biggest issues on OCR's radar. Risk Analysis, Encryption, and Regular Reviews. No time like right now...
So please let me know if you have any questions, and do check my news, resources, and upcoming training sessions sections on www.lewiscreeksystems.com -- I have lots of training sessions scheduled, including two more intensive two-day HIPAA training sessions, now set for Chicago August 29 and 30, and Phoenix October 24 and 24.
-- With Apologies to Judy Garland, Harold Arlen, and a Cast of Flying Monkeys --
"Auntie Em! Auntie Em! There's a twister a-comin'!" Well, I won't vouch for the accuracy of the quote, but I see some pretty ugly clouds on the horizon. A few comments from Federal officials, a job posting, and a conversation with someone whose company went through one of the random audits last year, and now I'm concerned. Is there a HIPAA storm cellar? You may want one.
I guess I'm not reporting anything new if I take note of the numerous public comments by HHS officials that in the first round of random audits, they found that entities weren't doing much internal auditing of system and network activity to ensure proper use of systems and data by the appropriate people. It's also nothing new that the folks heading up the HHS Office for Civil Rights have said that enforcing the auditing requirements will be a focus of their work in the coming months. And I'm sure I'm among thousands of people on the HHS mailing list that in the last week received a notice that HHS OCR was looking to hire people to do HIPAA privacy and security audits. That's troubling enough. Those two things mean that if you haven't started to follow up on the HIPAA Security Rule's system monitoring and activity review safeguards, you're leaving yourself open to fines and corrective action plans with a growing workforce dedicated to enforcement, full-time.
But then I had a nice long talk yesterday with someone whose organization was audited by HHS in a random audit last summer. For five days, the hired guns from KPMG lived in a conference room and collected information. Asking questions, verifying answers, verifying the verification, almost like automatons, no emotion, no human interaction, really. The questions they asked were the ones in the HIPAA Audit Protocol (http://www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/protocol.html), and that's scary enough, but in many ways the audit was like a SSAE16 (formerly SAS70) SOC2 audit, in that they were looking to see how well the organization sticks to its policies, whatever they are. Out of some 300 employees, one had missed their annual required HIPAA training, because that person was out and couldn't attend despite almost heroic efforts to do so, and the auditors wrote it up as a deficiency. They backed down after a letter from the organization's lawyer, but the point is, if you have a policy, you had better be sure you're doing what it says you do, or you will have to defend your actions, and that's just plain expensive, time consuming, and unpleasant.
-- If I Only Had a Brain --
So, let's take that little nugget of truth and apply that to the internal auditing issue. Are you starting to feel a little bit of, "Oh, I haven't really been doing enough," in the pit of your stomach? I know there are plenty of internal auditing policies out there that call for regular reviews, which is what HHS says is necessary, but has everyone been doing those reviews? I doubt it. It's among the most time consuming, boring, annoying tasks in security, and everyone hates it. So, what do you do?
First of all, start doing something and document it. Schedule regular reviews of access lists. Schedule a regular random audit of at least one employee's computer use, and one patient's access history. It doesn't have to be much, but you have to do something and you have to do it on a regular basis, not just when there's a complaint or some other event. See what your policy calls for, and write the procedures, and then, most importantly, audit your auditing compliance to make sure you're doing what your policies and procedures call for! What you can show in documentation and what the policies and procedures call for MUST match! You can have a great auditing policy, and you may have some great audits, but if they don't match, you're going to have some explaining to do. Ugh.
Here is everyone's homework for this week: Look up your HIPAA security internal audit policy -- system activity reviews, access reviews, those kinds of things. Do you have one? Do you have any supporting procedures that say how you, in your facility, will do those audits? If you already have these in writing, start doing them now, and then see how well you can actually do what you're saying you do. Be prepared to make some adjustments in your procedures so you can have a defensible position if you're audited -- and document everything!
"But I have such tight access controls that it would be nearly impossible for someone to access information improperly!" Then your audits will be quick and easy verifications. You can't get out of it -- you have to verify.
-- Somewhere Over the Rainbow --
(Am I going to be getting into trouble with the copyright lawyers for all these references?)
HIPAA compliance does sometimes feel like it's somewhere over the rainbow, but what is it like back in dusty, old, black-and-white Kansas, Dorothy? There are actually things you can do to be prepared. First of all, get to know the HIPAA Audit Protocol. Go to the Web site, check just the "Security" questions, select the popup to show "all", click the button to "Export to CSV", and open the file in your favorite spreadsheet. Do some formatting so you can actually read things and use it, add some columns to show your answers, to identify your documentation, and to say what you need to do to improve things. Go through the questions. Once you go through this exercise, you will know your weaknesses, and you will see what you need to put time into so you can have good answers when the auditors call you.
You will probably see that you have deficiencies in your auditing activities, procedures, and documentation. You will then have justification to spend the time you need to on getting your policies and procedures up to snuff and documented, to begin following them, and to make adjustments so your activity matches your policy and procedure. And make sure everything is properly documented.
And maybe if you're picked for a random audit it won't feel like the flying monkeys are out to get you.
I keep chipping away at the issues related to the new final HIPAA rules (aka HIPAA2), looking for insights into the bottom-line question, "Just what needs to happen to become compliant with the new rules?" I provided a little bit of an outline in my last message, but the issues surrounding the changes to Breach Notification need a little more exploration at this point. In upcoming discussions I'm sure I'll be tackling the scope of the changes to the Privacy Rule, but for the moment I'll fill in a few blanks relating to the Security Rule and Breach Notification.
-- Security and Breach Rule Policies
For the most part, changes to the Security Rule consist of adding "...and Business Associates..." to many of the sections, and doing so probably won't affect your Information Security Policies. The changes may need to be reflected in your policy on Business Associates if the policy is specific about BA agreement contents and doesn't refer to the HHS regulations identifying required content (or even better, the Web page for that, http://tinyurl.com/7asm2qj ). If the policy does refer to the regulations, it's probably fine as is.
So, with a little review (make sure you do actually review your policies, please), you'll probably decide your Security policies need little, if any, modification to meet the new rules, except when it comes to Breach Notification. I suspect most policies refer to the old "harm standard" (I know the ones I've supplied in the past did), and those paragraphs will need to be replaced with consideration of the new four-factor risk assessment for probability of disclosure. It's well worth your taking a moment to read through the new definition of a breach, under §164.402, FR page 5695, or page 131 of the PDF version, http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pdf/2013-01073.pdf .
-- How to Evaluate a Breach
The key here is to change your thinking about breach evaluation. Instead of "we don't have to report unless there's harm," the new rules say "we have to report unless there's a defined exception, or unless there's a low probability of compromise." The process to decide whether an incident is a reportable breach is this:
Step 1) Was the data encrypted according to the HHS guidance with strong passwords and are the passwords still secure? If so, not a breach. Document and done. Note that if you did use some kind of encryption but it doesn't meet the official requirements, it may still get you some points to use in step 3.
Step 2) OK, so if it wasn't properly encrypted; does it meet one of the defined exclusions in §164.402's definition of Breach? i) For unintentional, good-faith acquisition or use within the scope of authority and no further use or disclosure, ii) for inadvertent disclosure by someone ordinarily authorized to access the information within the same covered entity, business associate, or organized health care arrangement, or iii) if the disclosed information could not be retained by the unauthorized recipient. If you meet an exclusion, document and done. But do note that the exclusion under ii applies only to the same entity. If you inadvertently fax to another office not part of the same entity, that does NOT qualify for the exclusion. But it may get you points to use in step 3, compared to faxing to the hardware store.
Step 3) Well, it wasn't encrypted according to the guidance, and it doesn't meet an exclusion, so it's a reportable breach, UNLESS you can show a "low probability of compromise" based on a risk assessment considering at least the four factors identified in the regulation. Whereas before it was, "there's a hole, do we have to jump in?" now it's "we're in a hole, how can we dig our way out of it?"
An issue with any one of the Four Factors (didn't they have a Motown hit back in the 60s?) can be enough to raise the risk of a compromise above the "low" level. All four must be well controlled. The factors are, 1) what is the data (nature and extent, and likelihood of identification), 2) to whom was the disclosure made, 3) was the information actually acquired or viewed, and 4) have the risks been mitigated.
-- How Can You Implement This?
I'd recommend your policy point to the regulation (45 CFR §164.400 et seq.), and you implement procedures to support the policy that will take you through the Three Steps and the Four Factors (is this becoming a battle of the bands?)
Let's run through a quick set of examples: Let's say someone in your office faxes some health information to another office within your covered entity, but it is not the intended office. Well, it's on the fax machine, so it's not secured, so go to step 2. In this case, it meets the exception under ii, so it's not a reportable breach. Document and done.
What if it's faxed to another doctor's office that happens to be a different covered entity from yours? In this case, you have to go to Step 3, and evaluate the Four Factors. Let's say this is information about a dermatology skin patch test that went to the wrong dermatologist, was not actually viewed, and was shredded.
- Factor 1: The data is not sensitive, not extensive, just one simple test result. Sounds OK, not too risky.
- Factor 2: The disclosure was to another doctor's office also under HIPAA rules to protect all PHI no matter the source. Sounds OK there, too.
- Factor 3: Was the information viewed? In this case, let's say the receiving person realized the fax was misdirected and did not look at the pages behind the cover sheet and learned nothing other than that a fax was sent from an office erroneously. In that case, sure, that sounds OK too.
- Factor 4: The fax was shredded and the risk was fully mitigated. Also good news.
In this case, document your analysis, and you'd be justified in coming to a conclusion of there being a "low risk or compromise".
-- Some Variations on the Factors
But how about if, instead of a skin patch test result, it's HIV/AIDS test results? BAM! There goes factor 1. VERY sensitive information. Must report. Likewise if it's a complete record with lots of detail.
Or, how about if it's the hardware store instead of a HIPAA-covered entity that receives the fax? BAM! There goes factor 2. Must report.
Or, if the person receiving the fax discusses the contents with someone in their office? BAM again. Factor 3. Report.
Or, if you don't actually know that the fax was shredded? Factor 4. Report.
Any one of the factors can push your risk assessment above the "low probability of compromise" level.
-- So What Does That Leave?
At this point, we've covered what needs to happen for Security and Breach Notification Rule compliance. Do note, though, that the new requirements do not go into effect until March 26, 2013, and are not required to be used until September 23, 2013. Until March 26, you must still use the "harm standard". Between March 26 and September 23 you can use EITHER the old standard, or the new process. After September 23, you must use the new rules.
Next time I'll start digging into some of the many Privacy Rule issues.
And, as always, let me know if you have any questions, and do keep up with my list of upcoming seminars and Webinars at http://www.lewiscreeksystems.com/upcoming_public_seminars.html
As time goes by and we in the compliance community have the opportunity to digest the new rules a bit more and dig deeper into some of the tidbits hidden in the Preamble to the changes, new details will emerge, new understanding will develop, and framework for HIPAA update implementation will emerge. Here's how it looks so far:
-- A Framework for Implementing the HIPAA Changes
1) Policies will need to be modified or adopted to deal with the changes to business associates, individual access, breach notification, marketing and fundraising, and lots more. This will not be a simple job, depending on the complexity of your current policies, and must be executed by September 23, 2013.
2) Your Notice of Privacy Practices will need to be updated to reflect the new patient rights, and may be modified to remove language no longer required pertaining to some marketing activities that now will require an authorization instead. This also will need to be implemented by September 23, 2013. Providers will NOT have to mail out a new one to patients, but will need to use it and make it available and properly posted in their offices and on their Web sites.
3) Update your Business Associate Agreements to meet the new standards, and while you're at it, add in beefier protections for breaches, liability and indemnifications, so you don't get caught holding the bag if a BA plays fast and loose with your PHI. Luckily, the big news is that upon official publication of the new rules on January 25, 2013, they also released updated HIPAA Business Associate Agreement template provisions, available at the same Web address as the old, ancient, obsolete version: http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html (Shorter link: http://tinyurl.com/7asm2qj )
Now, just as before, this language is hardly stuff your lawyer would like you to sign as is, but it does identify the elements that must be in a modern BAA meeting the new standards. Do not adopt it as is, but use it to look at your current template and agreements, identify needed changes, and work with your attorney to implement those changes in a way that is legally correct for you, in your state.
Compliant BAAs under the old rules in place as of January 25, 2013 have until September 23, 2014 to be updated, and this includes "evergreen" contracts that auto-renew without intervention. Any new or manually renewed contracts must meet the new requirements by September 23, 2013.
4) And then once you implement the new policies, NPP, and BAAs, you'll need to make sure the proper procedures are developed and training takes place so it all works.
-- Speaking of Business Associates...
I've long spoken of the issues of the proposed rules for Business Associates, providing an example of how the shredding company for a business associate that provides services using PHI on behalf of a covered entity could unwittingly find itself under the regulations of the US Department of Health and Human Services, with significant compliance obligations and penalties for non-compliance. I spoke of how difficult it would be to educate all the business associates and their subcontractors all the way down the chain to implement the rules fully.
Well, it's even more complicated than that. Here's a scenario: You have an official e-mail system that your office uses for all professional communications and you have a policy that says staff should ONLY use that system. One staffer goes outside of the policy and uses G-mail to send someone in another office some PHI. Under the new rules? BAM! Google is a Business Associate because they have access to your firm's PHI. Without any notice or intervention, and despite any terms of service they might wish to implement. With that one act, both you and Google are in violation of the HIPAA BA rules, without your or their knowledge.
Needless to say, there are some serious issues that result from this interpretation, and we will just have to see how this shakes out. Will there be forthcoming guidance that softens the blow? That doesn't seem likely given the wording in the preamble to the new rules, but it could happen. Here is a link to a good article by Health IT lawyer John Christiansen discussing this topic and the impacts in some cloud and ISP circumstances: http://christiansenlaw.net/2013/01/do-the-hitech-rules-really-make-all-healthcare-asps-and-cloud-services-providers-business-associates/ (Or use this short link: http://tinyurl.com/b29f4x2 )
Isn't HIPAA fun?
-- And if I've provided you any BAA or policy language in the past...
It probably needs updating. I'll try to be proactive and let you know, although a lot of policies and agreements have been developed over the last ten years of HIPAA. If you have questions about yours, please let me know and we can set up a review. Also, I have four Webinars this week and next, on Breach Notification, E-mail and Texting, the new Final Amendments, and Business Associates -- I'll be including the new rules in all of these. See my page for more information on these and many more: http://www.lewiscreeksystems.com/upcoming_public_seminars.html
Please let me know if you have questions -- I'm always happy to help!
Well, the big news is that we've finally been treated to a new final HIPAA rule, issued last Thursday, true to form, just before a holiday weekend, all 563 pages. A great deal is "as proposed" but there are some significant changes and some significant insights provided in the preamble. Here's a link to the pre-publication version https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-01073.pdf The actual date of issue of the official version in the Federal Register will be this Friday, January 25, whereupon the link above may stop working and links to the official version will be announced.
DISCLAIMER! I am not a lawyer and everyone in the HIPAA world is still sorting out all the impacts and changes, and I'd be a fool to think that I know what all the issues are and have everything interpreted correctly at this early stage. This is not a complete analysis, but just a few observations, and I'll have more information as things develop.
So, what's up with the final rule? For the most part, it's being finalized as proposed, but with some significant exceptions. Here are some tidbits.
-- Business Associate Agreement Compliance Timing
The new rule, as proposed, extends the HIPAA regulations to Business Associates, and there are changes in what is required in a Business Associate Agreement to reflect the new status of BAs. The sequence of compliance in HIPAA is usually that the rule is officially Published (as this one will be on Friday the 25th), it goes into effect 60 days later, and is enforceable 6 months after that. The proposed rule said that if your BA agreement was in compliance with the old rules as of the effective date, you'd have 18 months to get your BA Agreement up to snuff, not just 6 months, so you'd have some time, once it was published, to at least nail down what you could under the old requirements and not have to look at it again for 18 months.
Well, surprise, surprise, the final rule says that if your BA agreement is compliant as of the day of publication, not the effective date, you get the extra year to get your agreements updated. You don't get that 60 days before it goes into effect to sign agreements under the old rules and put off revisiting them for 18 months. In other words, you have until this Friday to sign any agreements that are compliant with the old rules and not have to revisit them for 18 months. Starting next week, you'll have to use agreements meeting the new requirements, or you'll have to revise them by September 23, 2013.
I've been recommending that folks include language that meets the new requirements for some time now, so if you have, you may be all set to continue into the future and have until September 24, 2014 to revise all the older ones.
-- Breach Notification: The Harm Standard is Dead, Long Live the Harm Standard
We all knew that there would be some changes in the Harm Standard in Breach Notification because of the controversy around it, and a perceived lack of uniformity in the industry as to how to interpret it. Well, there sure are some changes. The Harm Standard has been unceremoniously dumped, replaced by the notion of a "low probability of compromise" using a risk assessment of each potential breach, considering four factors: what the information was, to whom it was released, whether or not it was actually accessed, used, or disclosed, and how the incident was mitigated. OK, so far so good...
Interestingly, in the Preamble discussion of the new rule, one of the considerations in evaluating the information potentially breached is whether or not its exposure is adverse to the individual or benefits some other person. It sounds like the "adverse to the individual" is a new harm standard, without the icky name. Now, to be sure, you need to look at more than this to see if it's reportable -- any one of the four factors can drive notification. But it does allow some room for consideration of the impact on the individual.
The big impact here is that you do need to establish a process for assessing the risk of every potential breach to see if it is reportable.
One of the best things I noticed in the new rule was in the Preamble discussion having to do with sending information to the wrong provider by mistake. Under the interim rule there was not an exception for inadvertently sending to the wrong HIPAA-covered entity. There still is no exception, but the Preamble discussion did make it clear that you can use a risk assessment considering the four factors to decide that there is not a reportable breach. Just don't make it automatic! You still need to do the risk analysis every time -- you may have situations where it's not something you can except.
-- Some Guidance on Unencrypted E-mail (and Texting?)
One of the new requirements unchanged from that proposed is that if someone wants an electronic copy of their health information that's held electronically, you must provide that. No news there -- it's in the HITECH Act and in the proposed rule, and also in the Meaningful Use requirements for anyone going for incentive funding for their EHR. What is news is the discussion in the preamble about how to transmit that information to the individual. In short, if the individual wants you to e-mail them any PHI, you need to explain that it is not necessarily secure and that the information may be exposed, and ask if they want to do that anyway. If they say, "yes, e-mail me anyway, I understand and accept the risks," then e-mailing PHI is fine. They note that individuals don't necessarily have the savviness to manage decryption processes, and they have a right to ask for their information however they want it (within reason), so e-mailing is fine. Don't forget: DOCUMENT the discussion and agreement to accept the risk.
This logic may also be extended to texting. If the individual says, "text me my test results", and you explain the risks and they say do it anyway, you may. DOCUMENT it.
Note that this does not exempt professional communications! Any professional exchange of PHI over the Internet MUST be encrypted to avoid breaches. The ability to avoid encryption only applies to communication with the individuals. Also, keep in mind that if you're going for incentive funding for your EHR, you need to provide a secure portal for patient access of information, which would minimize the need for e-mailing of PHI anyway.
Also note that I feel it would be foolish to not consider the content of any unencrypted e-mail or texting. I would resist sending unencrypted information of a particularly sensitive nature, or any information that may be covered by more stringent regulations, such as substance abuse or HIV/AIDS information. I think it is important to show that in your discussion to not encrypt that the nature of the information was considered. If you're just wanting to text someone so you can say you're running 10 minutes late for their appointment, that's a low risk situation, and not the same as telling someone their oncology test was positive. Use your judgement and document it!
-- Is That All, Folks?
Not by a long shot. I'm digging deep into this because I have webinars and seminars on HIPAA this week and next and on into the year. Nothing like having to teach someone else to force you to really know your material! I'm sure we'll all be finding little gems as we in the compliance community come to grips with the new rules. Here is the obligatory link to my page of upcoming sessions: http://www.lewiscreeksystems.com/upcoming_public_seminars.html
Please let me know if you have any questions (how could you not... I certainly do!). I'll do my best to sort things out for you, and I'll try to pass along any insights as they occur to me. There is certainly a lot that can be found in 563 pages, to be sure!