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GDPR and Why U.S. Healthcare Providers Should Care

Posted on April 19, 2018 I Written By

The following is a guest blog post by Steven Marco, CISA, ITIL, HP SA and President of HIPAA One®.

Steven Marco - HIPAA expertThe European Union (EU) has drafted guidance to give citizens more control over their personal data, so what does this mean for U.S. based healthcare providers?

On May 25, 2018, the EU will roll out General Data Protection Regulation (GDPR), a new set of rules that is similar in nature to HIPAA compliance for EU countries. The effort to create GDPR started years ago in January 2012, when the European Commission began working on plans to create data protection reform across the EU so that European countries would have greater controls in place to manage information in the digital age. Additionally, GDPR aims to simplify the regulatory environment for businesses so both European citizens and businesses can benefit from a digital economy.

Being that GDPR has not yet taken effect, there are aspects to this new framework that are difficult to fully understand and define at this time yet we do know that U.S. companies DO NOT need to have business operations in one of the 28-member states of the EU to be impacted by GDPR. The new set of rules will require organizations around the world that hold data belonging to individuals who live in the EU to a high level of protection and must be able to account for where every bit of data is stored.

The good news is a large majority of U.S. based healthcare providers will be relatively safe in terms of complying with GDPR. If your organization is not actively marketing your services in the EU or practicing in the EU, a data breach where an EU citizen’s PHI is compromised would most likely be your most realistic brush with GDPR.

For instance, a walk-clinic in New York City seeing many international tourists has a much higher chance of being impacted than say a rural clinic treating mostly local residents. Providers in larger cities with more diverse patient groups will need to be extra vigilant regarding their breach notification standards and security posture.

Want to learn more about how your healthcare organization can prepare for GDPR? Read this HIPAA One blog post to learn how your practice can prepare now for a more international data sharing climate.

About Steven Marco
Steven Marco is the President of HIPAA One®, leading provider of HIPAA Risk Assessment software for practices of all sizes.  HIPAA One is a proud sponsor of EMR and HIPAA and the effort to make HIPAA compliance more accessible for all practices.  Are you HIPAA Compliant?  Take HIPAA One’s 5 minute HIPAA security and compliance quiz to see if your organization is risk or learn more at HIPAAOne.com.

Should Apps with Personal Health Information Be Subject to HIPAA?

Posted on April 10, 2018 I Written By

The following is a guest blog post by Erin Gilmer (@GilmerHealthLaw).

With news of Grindr’s sharing of user’s HIV status and location data, many wonder how such sensitive information could be so easily disclosed and the answer is quite simply a lack of strong privacy and security standards for apps.  The question then becomes whether apps that store personal health information should be subject to HIPAA? Should apps like Grindr have to comply with the Privacy and Security Rules as doctors, insurance companies, and other covered entities already do?

A lot of people already think this information is protected by HIPAA as they do not realize that HIPAA only applies to “covered entities” (health care providers, health plans, and health care clearininghouses) and “business associates” (companies that contract with covered entities).  Grindr is neither of these. Nor are most apps that address health issues – everything from apps with mental health tools to diet and exercise trackers. These apps can store all manner of information ranging simply from a name and birthdate to sensitive information including diagnoses and treatments.

Grindr is particularly striking because under HIPAA, there are extra protections for information including AIDS/HIV status, mental health diagnoses, genetics, and substance abuse history.  Normally, this information is highly protected and rightly so given the potential for discrimination. The privacy laws surrounding this information were hard fought by patients and advocates who often experienced discrimination themselves.

However, there is another reason this is particularly important in Grindr’s case and that’s the issue of public health.  Just a few days before it was revealed that the HIV status of users had been exposed, Grindr announced that it would push notifications through the app to remind users to get tested.  This was lauded as a positive move and added to the culture created on this app of openness. Already users disclose their HIV status, which is a benefit for public health and reducing the spread of the disease. However, if users think that this information will be shared without explicit consent, they may be less likely to disclose their status. Thus, not having privacy and security standards for apps with sensitive personal health information, means these companies can easily share this information and break the users’ trust, at the expense of public health.

Trust is one of the same reasons HIPAA itself exists.  When implemented correctly, the Privacy and Security Rules lend themselves to creating an environment of safety where individuals can disclose information that they may not want others to know.  This then allows for discussion of mental health issues, sexually transmitted diseases, substance use issues, and other difficult topics. The consequences of which both impact the treatment plan for the individual and greater population health.

It would be sensible to apply a framework like HIPAA to apps to ensure the privacy and security of user data, but certainly some would challenge the idea.  Some may make the excuse that is often already used in healthcare, that HIPAA stifles innovation undue burden on their industry and technology in general.  While untrue, this rhetoric holds sway with government entities who may oversee these companies.

To that end, there is a question of who would regulate such a framework? Would it fall to the Office for Civil Rights (OCR) where HIPAA regulation is already overseen? The OCR itself is overburdened, taking months to assess even the smallest of HIPAA complaints.  Would the FDA regulate compliance as they look to regulate more mobile apps that are tied to medical devices?  Would the FCC have a roll?  The question of who would regulate apps would be a fight in itself.

And finally, would this really increase privacy and security? HIPAA has been in effect for over two decades and yet still many covered entities fail to implement proper privacy and security protocols.  This does not necessarily mean there shouldn’t be attempts to address these serious issues, but some might question whether the HIPAA framework would be the best model.  Perhaps a new model, with new standards and consequences for noncompliance should be considered.

Regardless, it is time to start really addressing privacy and security of personal health information in apps. Last year, both Aetna and CVS Caremark violated patient privacy sending mail to patients where their HIV status could be seen through the envelope window. At present it seems these cases are under review with the OCR. But the OCR has been tough on these disclosures. In fact, in May 2017, St. Luke’s Roosevelt Hospital Center Inc. paid the OCR $387,200 in a settlement for a breach of privacy information including the HIV status of a patient. So the question is, if as a society, we recognize the serious nature of such disclosures, should we not look to prevent them in all settings – whether the information comes from a healthcare entity or an app?

With intense scrutiny of privacy and security in the media for all aspects of technology, increased regulation may be around the corner and the framework HIPAA creates may be worth applying to apps that contain personal health information.

About Erin Gilmer
Erin Gilmer is a health law and policy attorney and patient advocate. She writes about a range of issues on different forums including technology, disability, social justice, law, and social determinants of health. She can be found on twitter @GilmerHealthLaw or on her blog at www.healthasahumanright.wordpress.com.

Cybersecurity Report Card:  Better Performance, But Not Great

Posted on March 29, 2018 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

A new research report from HIMSS has concluded that while healthcare organizations are improving their cybersecurity programs, there’s still a number of things they could do better.

The study drew on responses from 239 health information security professionals. Their responses were gathered from December 2017 to January 2018. While respondents came from a number of settings, the largest number (31.5%) were with hospitals, multi-hospital systems or integrated delivery networks.

One key point made by the study was that significant security incidents are projected to continue to grow in number, complexity and impact. That’s reflected by responses from survey participants, 75.7% of whom said that their organizations experienced a significant security incident in the past 12 months.

The top threat actors attacking these organizations included online scam artists deploying phishing and spear phishing attacks (37.6%), followed by negligent insiders (20.8 %) or hackers (20.1%). In many cases, the initial point of security compromise was by email. Time it took to discover the incident included less than 24 hours (47.1%), one to two days (13.2%) and 3 to 7 days (7.4%).

Despite these risks, and the effort required to protect their data, healthcare organizations with cybersecurity programs are improving their performance. They’re devoting more resources to those programs (55.8% of current IT budgets), responding to problems identified by regular risk assessments (with 83.1% adopting new and improved security measures in the wake of those assessments) and regularly conducting penetration testing and security awareness training.

On the other hand, HIMSS found that most healthcare organizations, cybersecurity programs still need improvement. For example, staffers face major obstacles in remediating and mitigating security incidents, particularly having too few cybersecurity personnel on board and a lack of financial resources. HIMSS also noted that educating and testing “human components” for security vulnerabilities is critical, but may not be included in many efforts.

In some cases, organizations don’t have formal insider threat management programs. While many respondents (44.9%) said they do have insider threat management programs and policies in place, another 27% said those programs were informal. And 24.2% said their organization had no insider threat management program at all.

In addition, risk assessments vary widely across the industry. Popular sources used to gather cyber threat intelligence include US CERT alerts and bulletins (60%) and HIMSS resources (53.8%), but many others are used as well.

The net of all of this seems to be that while healthcare organizations have gotten smarter where cybersecurity is concerned, they need to invest more in specialized personnel, improve staff training, remediation and risk assessments and stay alert. As the number of attacks continues to grow, nothing else will get the job done.

Texting Patients Is OK Under HIPAA, as long as you…

Posted on March 6, 2018 I Written By

Mike Semel is a noted thought leader, speaker, blogger, and best-selling author of HOW TO AVOID HIPAA HEADACHES . He is the President and Chief Security Officer of Semel Consulting, focused on HIPAA and other compliance requirements; cyber security; and Business Continuity planning. Mike is a Certified Business Continuity Professional through the Disaster Recovery Institute, a Certified HIPAA Professional, Certified Security Compliance Specialist, and Certified Health IT Specialist. He has owned or managed technology companies for over 30 years; served as Chief Information Officer (CIO) for a hospital and a K-12 school district; and managed operations at an online backup company.

OCR Director Severino Makes Policy from the Podium

Speaking at the HIMSS health IT conference in Las Vegas on Tuesday, Roger Severino, Director of the US Department of Health and Human Services Office for Civil Rights (OCR), the HIPAA enforcement agency, said that health care providers may share Protected Health Information (PHI) with patients through standard text messages. Providers must first warn their patients that texting is not secure, gain the patients’ authorization, and document the patients’ consent.

In 2013, the HIPAA Omnibus Final Rule allowed healthcare providers to communicate Electronic Protected Health Information (ePHI) with patients through unencrypted e-mail, if the provider informs the patient that their e-mail service is not secure, gains the patient’s authorization to accept the risk, and documents the patient’s consent.

A HIMSS audience member asked Severino why the OCR hasn’t issued similar guidance for text messaging with patients. “I don’t see a difference,” Severino said. “I think it’s empowering the patient, making sure that their data is as accessible as possible in the way they want to receive it, and that’s what we want to do.”

“Wow! That’s a big change,” said Tom Leary, Vice President of Government Relations for HIMSS. “That’s wonderful. Actually, the physician community has been clamoring for clarification on that for several years now. Our physician community will be very supportive of that.”

The 2013 OCR guidance for e-mails,  and Severino’s announcement about text messages, only applies to communications with patients. All HIPAA Covered Entities and Business Associates are still forbidden to use unsecure communications tools to communicate with each other.

Messages sent through free e-mail services are not private. Google’s Gmail Terms of Service, allow Google to “use…reproduce…communicate, publish…publicly display and distribute” your e-mail messages. Health care providers must use encrypted e-mail or secure e-mail systems to communicate ePHI outside of their organizations.

In 2012, a small medical practice was penalized $ 100,000 for sharing patient information through free Internet services, including e-mail.  According to the resolution agreement, Phoenix Cardiac Surgery “daily transmitted ePHI from an Internet-based email account to workforce members’ personal Internet-based email accounts.”

While the OCR may be best-known for its HIPAA enforcement, it has pushed healthcare organizations to lower barriers that have prevented patients from obtaining their medical records. The Omnibus Rule required health care providers to only recover actual costs when providing patients with copies of their records.

In its 2016 guidance, the OCR set a $ 6.50 limit (inclusive of all labor, supplies, and postage) for health care providers “that do not want to go through the process of calculating actual or average allowable costs for requests for electronic copies of PHI maintained electronically.”

The federal requirement to recover actual costs, or a flat fee of $ 6.50, supersedes state laws that allowed providers to charge for medical record searches and per-page fees. Maine caps the cost at $ 250 for a medical record, far above the federal $ 6.50 flat fee.

 

CES Really Scared Me. Will HIMSS Make Me Feel Any Better?

Posted on February 22, 2018 I Written By

Mike Semel is a noted thought leader, speaker, blogger, and best-selling author of HOW TO AVOID HIPAA HEADACHES . He is the President and Chief Security Officer of Semel Consulting, focused on HIPAA and other compliance requirements; cyber security; and Business Continuity planning. Mike is a Certified Business Continuity Professional through the Disaster Recovery Institute, a Certified HIPAA Professional, Certified Security Compliance Specialist, and Certified Health IT Specialist. He has owned or managed technology companies for over 30 years; served as Chief Information Officer (CIO) for a hospital and a K-12 school district; and managed operations at an online backup company.

Are Consumer Health Care Products Accurate & Safe Enough for Your Healthcare?

At CES, the monstrous electronics show, I saw lots of consumer devices advertised for personal fitness and healthcare. There was even a Digital Health Summit, with a wide range of industry experts.

Some companies were promoting their ability to send data to healthcare providers. That’s scary, since there are no standards governing many of these devices.

A clear message from CES is that the divisions between ‘technology’ and ‘devices’ are diminishing. Alexa, Google Home, and Siri, won’t be tied to stand-alone devices for long. They will be integrated into a wide range of consumer products across a home network, your car, portable devices, and the Internet. It’s not a big leap of the imagination to think that you will be telling Alexa, in your refrigerator, to reset the alarm clock in your bedroom, for an early meeting. And that Alexa will be telling you that you gained a pound, and send that data to your doctor.

Considering the recent news about Amazon getting into healthcare, with Warren Buffet and JP Morgan, it’s logical to think that Amazon will be delivering our healthcare along with our packages. Will you get a colonoscopy notification from Amazon because someone orders a 50th birthday card for you? (Will they only use lubricant if you have Prime? Ok, that might have been a little harsh.)

Loud and clear from CES is the consumerization of healthcare, and it’s scary.

Will data from your consumer products be accurate enough for a health care provider to form a professional opinion?

Will your devices be safe from hacking and interference?

Who will be liable if something bad happens to you because your data wasn’t accurate, or was delayed in transmission?

Should there be a government or industry-based organization setting standards and certifying devices?

ACCURACY

Valencell makes biometric sensor chips for companies to use in their consumer products. They displayed stylish brand-name smart watches that imbed their biometric-sensor chips.

Valencell’s President, Steven LeBoeuf, said that there are no standards for consumer heart monitors. His chips are voluntarily lab-tested and certified for accuracy. He said that some of their competitors’ products can confuse a person’s steps, as they are walking or running, as a heartbeat.

While that might not matter too much to a person casually checking their own vitals, what will happen if incorrect data is sent upstream to your healthcare provider?

This diagram, produced by iHealth, a company that makes ‘consumer-friendly, mobile personal healthcare products that connect to the cloud’, clearly shows their expectation that your data will be communicated to hospitals.

iHealth aptly describes this as a Systematic Framework. Think about how many vendors will be involved in the system. Device manufacturers, chip manufacturers, software designers, programmers, computer companies, communication networks, Internet service providers, cloud services, and more, all before data gets to the hospital.

What if there is a failure? What happens to you if your healthcare is depending on a consumer device? Who is responsible for the security and accuracy of the data through the system? Wanna bet that everyone will be pointing their finger at someone else?

SAFETY

What will protect you from your devices? There are an increasing numbers of stories of consumer products and autonomous cars – the Internet of Things (IoT) – being hacked.

In August, 2017, the FDA issued a warning that a pacemaker was vulnerable to hackers who could remotely kill the battery or modify the performance of the pacemaker. Killing the battery could kill the patient. Remember that this recall occurred because a pacemaker is a medical device governed by the FDA, which doesn’t govern consumer healthcare products.

The Equifax breach, the Spectre and Meltdown flaws in computer microchips, and hackers hijacking baby monitors and surveillance cameras, all show the importance of being able to apply software and firmware patches and updates.

It took a long time for the government to require car companies to recall vehicles for safety problems. How many people will be hurt, or die, before consumer health care products get regulated?

LIABILITY

At CES, AIG Insurance presented this graphic of survey results showing who is liable for a driverless vehicle crash.

Imagine personal injury attorneys salivating over consumer health care product failures. Imagine new types of insurance coverage – or new types of policy exceptions – related to managing healthcare based on consumer product data.

STANDARDS & REGULATIONS

What’s the difference between a medical device and a consumer health care product? What defines a heart monitor? How accurate is a scale? How will a consumer health care product receive security patches? How will consumers be notified their health care products aren’t safe?

Do we want the federal government involved? In 1966, the National Traffic and Motor Vehicle Safety Act required auto manufacturers to notify the government and consumers of safety defects, and recall vehicles. Could our dysfunctional Congress ever agree on a plan to regulate consumer health care products?

What about the industry policing itself? At his annual briefing at CES, electronics industry veteran Shelly Palmer made his case for a Self-Regulatory Organization (SRO) to create and enforce standards to protect consumers from risks associated with the Internet of Things.

The model for this could be PCI-DSS, the Payment Card Industry Data Security Standards, that govern organizations that accept and process credit cards. This standard is self-regulated by a council founded by the credit card companies, and is not overseen by federal or state agencies. It covers credit card processing from end-to-end, from certifying the swipe device on the store’s counter all the way through the merchant processors and banks.

According to its website, the council “provides critical tools needed for implementation of the standards such as assessment and scanning qualifications, self-assessment questionnaires, training and education, and product certification programs.

If you are a healthcare professional, isn’t this the level of integrity and security you want for consumer products sending patient data to you?

Who would take on the responsibility, not to mention the liability, of policing consumer products sending data to healthcare organizations? The Consumer Technology Association (CTA), or the Health Information Management Systems Society (HIMSS)?

Will it take a disaster for us to find out?

Maybe I will find some answers at the HIMSS health IT conference. I sure hope so.

Health IT and ROI (Release of Information) Vendor Sues HHS Over Patient Records Fees

Posted on January 19, 2018 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Now here’s one for the ages – a vendor taking HHS head-on. The vendor, CIOX Health, has sued HHS in an effort to stop the agency from enforcing HIPAA rules limiting how much providers and business associates can charge patient records. While the vendor may not get anywhere, the lawsuit raises the important question of what patient record retrieval should cost.

According to Becker’s Hospital Review, the suit focuses on changes to the privacy law put into place in 2013 and 2016. The article notes that these modifications broadened the type of information providers and BAs must send while capping the fees vendors could charge for doing so. Specifically, the changes made in 2016 require that vendors that the costs associated with record requests for a reasonable or flat rate of about $6.50.

In its complaint, CIOX says the flat fee “was drawn from thin air and bears no rational relationship to the actual costs associated with processing such requests.” It contends that the HIPAA provisions in question established the limits “unlawfully, unreasonably, arbitrarily and capriciously.”

It’s hard to tell whether CIOX will get anywhere (though my guess is “not very far”). Government agencies are all but immovable, and HHS particularly so. I appreciate the spunk involved in filing the suit, the premise of which actually sounds reasonable to me, but I think the company has about as much chance of prevailing as a gnat fighting a combine harvester.

That being said, I think this suit focuses on an important issue, which is that the fee limits imposed by states and the federal government for providing medical records are all over the map. While such limits may be necessary to protect consumers, it’s probably fair to say that they aren’t exactly based on actual estimates of provider and vendor costs.

The truth is, the healthcare industry hasn’t come to grips yet with the cost of delivering healthcare information to patients. After all, while basic information delivered by a portal may be good enough for patients, these aren’t real medical records and they can’t be used as a basis for care.  And delivering an entire medical record can be expensive.

Plus, this issue is really complicated by the number of records requests that healthcare organizations are receiving from parties other than the patient. The number of records request from insurance companies, lawyers, and other third parties has increased dramatically. Not to mention how much of the record these organizations want to get. If it were just patients requesting their records, this question would be much simpler.

I can only think of a few ways to handle this problem, none of which are really satisfactory. For example, HHS or the states could create some sort of system which permits different fees depending on the difficulty of retrieving the information. Providers and business associates could submit their fees to some kind of review board which would approve or reject the proposal. Or perhaps we could just allow vendors to charge whatever the market would bear. None of these sound great to me.

If we want patients to manage their health effectively, they need to be able to share their records, and they must be able to access those records without paying a fortune for the privilege. At the same time, we can’t ask providers and business associates to share records at their own expense. Given the importance of this problem, I think it’s high time that healthcare leaders look for solutions.

Does Your HIPAA Risk Analysis Tool Protect Your Practice?

Posted on December 15, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Fourth quarter signifies more than a countdown to the holidays, many healthcare organizations are met with the realization that it is time to complete HIPAA risk analysis in order to comply with MACRA – MIPS. Of course, HIPAA risk analyses are nothing new, practices should be conducting  them regularly,  in light of the HIPAA Omnibus Rule which gave teeth to the regulations and made  an annual HIPAA risk analysis a requirement for every healthcare organization.

Recently, I was recently reading a blog post by HIPAA One called “Not All Risk Analysis Tools Created Equal” and it made me think about the requirements for a bona fide risk analysis. I realize that HIPAA One provides a risk analysis solution and therefore, approaches the conversation as a vendor would, however, they are also deeply embedded in the HIPAA risk assessment world and have a unique understanding of what’s happening.

I’ve seen first-hand the principle they describe in the post with many medical practices. Most medical practices are so overwhelmed  with the daily grind of dealing with staff issues, schedules, billing, supplies, etc that it’s hard for them to distinguish between a high quality risk analysis tool and one that was built 3 years ago and hasn’t been updated since then.

In HIPAA One’s blog post they offered a list of what you should look for in a HIPAA risk analysis solution and I think this is a great  starting point for any organization that needs a tool or is evaluating their existing tool:

  1. Industry-Certified Auditors on Staff – Verify the vendor has:
    1. Auditors who are certified professionals, such as CHPS, CISSP, HCISPP, CISA, etc. and
    2. Previous experience responding to AND PASSING government and private-sector audits.
  2. Compliance Gap-Assessment – This assessment determines if your workplace meets each of the HIPAA requirements as selected the Office for Civil Rights’ (OCR) HIPAA Audit Protocol.
  3. Mock-Audit – Put your money where your mouth is. If your workplace maintains HIPAA compliance, prove it with proper supporting documents and examples per the OCR’s HIPAA Audit Protocol.
  4. Risk Analysis –Bona Fide security risk analysis which digs into any non-compliant areas along with a calculation tool that addresses which gaps are low, medium or high risk to the organization using NIST-based methodologies (i.e. at minimum NIST800-30 rev1 and NIST 800-53 rev 4).
  5. Remediation Plan – This documented plan answers the questions: “Who will do what by when” in regards to remediating gaps in compliance.
  6. Final Report – Key deliverable proving compliance with HIPAA security risk analysis.
  7. Ongoing Tracking – Track the resolution of those gaps in compliance by proving due diligence in the event of an audit.
  8. Periodic Re-evaluation – Each year take a new “snapshot” performing steps 2-6 on any changes that happened from the previous year.

The item on this list that I see fall short in many solutions and services on the market today is the remediation plan. It’s amazing how many tools only account for a risk analysis, and do not provide any guidance on creating remediation plans for any risks you find. That’s a big deal and could leave you in trouble if your practice is ever audited and hasn’t remediated any of your security deficiencies .

The good news is that HIPAA risk analysis tools have come a long way over the years. ]  Much like you need to make sure EHR vendors are updating and improving their systems to meet your needs and comply with changes in government regulations, the same is true with HIPAA risk analysis tools. Make sure you take the time needed to ensure the quality of the tools and services you’re using. Ignorance is not bliss when a HIPAA audit occurs.

Note: HIPAA One is a Healthcare Scene sponsor.

Slow Learners Teach Big Lessons – $2 Million State HIPAA Penalty

Posted on December 4, 2017 I Written By

Mike Semel is a noted thought leader, speaker, blogger, and best-selling author of HOW TO AVOID HIPAA HEADACHES . He is the President and Chief Security Officer of Semel Consulting, focused on HIPAA and other compliance requirements; cyber security; and Business Continuity planning. Mike is a Certified Business Continuity Professional through the Disaster Recovery Institute, a Certified HIPAA Professional, Certified Security Compliance Specialist, and Certified Health IT Specialist. He has owned or managed technology companies for over 30 years; served as Chief Information Officer (CIO) for a hospital and a K-12 school district; and managed operations at an online backup company.

Editor’s Note: We’d like to welcome Mike Semel as the latest addition to the Healthcare Scene blog team.  We’ve been working with Mike for quite a while as a guest blogger, so it’s great to have Mike now covering security and privacy with us in a more formal capacity.  Check out all of Mike Semel’s EMR and HIPAA blog posts.

I think it is fair to call people slow learners if they get caught violating HIPAA:

  • after they published 50,000 patient records to the Internet for a 2-year period, so patients Googling themselves found their medical records,
  • and THEN DID IT AGAIN DURING THE INVESTIGATION for the first incident.

Duh.

On November 22, California Attorney General Xavier Becerra announced a $2 million settlement with Cottage Health System and its affiliated hospitals for violating both state and federal privacy laws. The settlement came after two separate data breaches where more than 50,000 patient records were made publicly available online. The state settlement is on top of a $4.125 million class-action settlement with its patients, that Cottage Health’s insurance company is trying to recover, because it said Cottage Health was not truthful on its insurance application.

It’s bad enough that from 2011 until 2013 (after it was notified by a patient that he found his medical records online), Cottage Health had a server with protected health information that was not encrypted, password protected, protected by firewalls, or protected against unauthorized access.

What is truly stunning is that, in 2015, during the federal investigation for the first incident, Cottage Health reported that it made another 4,596 patient records available online.

I have been the Chief Information Officer in a hospital, and know how bad executive and departmental management and oversight would have to be to create an environment where that can happen once, let alone twice.

Based on the complaint provided by the California Attorney General, there are a lot of lessons you can learn from this penalty.

LESSONS

1. It not just the OCR. This HIPAA penalty was issued by a state Attorney General. The federal HITECH Act (2009) gave state AG’s the authority to enforce civil penalties for violations of the HIPAA Privacy and Security Rules. It doesn’t take the federal Office for Civil Rights to go after you. It could be your state Attorney General, who is probably motivated by wanting to impress voters for his campaign to be governor or senator someday.

2. Know your state laws. California’s Confidentiality of Medical Information Act and Unfair Competition Law were also cited in the penalty. Forty-eight states, plus DC and Puerto Rico, have their own laws protecting Personally Identifiable Information. Some, like California, have state laws that protect medical records beyond the scope of HIPAA. State laws have different patient notification requirements than HIPAA’s maximum of 60 days. In California, patients must be notified within just 15 days.

3. Management should pay attention to security and compliance, before it has to sign $6 million in checks, plus legal fees. From the IT department to the executive suite, this penalty is proof that management was not validating the organization’s security and compliance.

Cottage Health isn’t a small, rural hospital with 25 beds, trying its best, with limited resources, to serve a community. According to its 2016 Annual Report, Cottage health generated over $746 million in revenue and had 3,120 employees.  Seventeen of them are Vice Presidents.

At least Cottage Health’s CEO didn’t publicly blame his IT guy, like the former CEO of Equifax did in front of Congress. Maybe he realizes he could have avoided spending $6 million by having better management.

4. Patients are Consumers, who are protected against Negligence & Unfair Business Practices. The $4 million settlement plus the $2 million penalty are proof that management was ignoring the commitment it made to its patients every day in the Cottage Health Notice of Privacy Practices.

Our Pledge
We understand that medical information about you and your health is personal, and we are committed to protecting it.

The Federal Trade Commission forced the closure of a small medical lab because it said the lab violated its prohibition of Unfair Business Practices by not protecting patient information.

There is a lawsuit in Connecticut where the state appeals court certified a Notice of Privacy Practices as a contract with a patient.

Yes, patients (and now their lawyers) really do read those notices. Treat yours with respect because it is a contract, not a brochure.

5. Don’t Assume Your HIPAA Compliance Program is Working. Not having policies, procedures, basic IT security like passwords and firewalls, means that a lot of Cottage Health managers and executives had to be asleep at the switch. Not complying with the HIPAA Security Rule, effective since 2005, which protects electronic data, means that Cottage Health’s compliance program was a mirage. I can imagine their compliance and security staff telling management that they had everything handled. Management believed them. Over 50,000 patients and an Attorney General disagree.

6. Prevent the Triggering Event. This wildfire started with a small spark. An IT engineer configured a server and plugged it into the network. Things as simple as checklists could have prevented the negligent publication of the medical records to the Internet.

The NIST Cybersecurity Framework (NIST CSF) is a 41-page document simple enough for even small organizations to use to improve their data security.

Bring in a qualified independent third party to evaluate your compliance and security against the HIPAA rules and the NIST CSF, and give the report directly to the CEO. Not a good use of the CEO’s time? It’s much better than the CEO’s involvement after an investigation has started.

7. If You Are Being Investigated, Don’t Let the Same Problem Happen Again. Duh.

Vanderbilt Disputes Suggestion That Larger Hospitals’ Data Is Less Secure

Posted on November 27, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Ordinarily, disputes over whose data security is better are a bit of a snoozer for me. After all, if you’re not a security expert, much of it will fly right over your head, and that “non-expert” group definitely includes me. But in this case, I think the story is worth a closer look, as the study in question seems to include some questionable assumptions.

In this case, the flap began in June, when a group of researchers published a study in JAMA Internal Medicine which laid out analysis of HHS statistics on data breaches reported between late 2009 to 2016. In short, the analysis concluded that teaching hospitals and facilities with high bed counts were most at risk for breaches.

Not surprisingly, the study’s conclusions didn’t please everyone, particularly the teaching-and high-bed-count hospitals falling into its most risky category. In fact, one teaching hospitals’ researchers decided to strike back with a letter questioning the study’s methods.

In a letter to the journal editor, a group from Nashville-based Vanderbilt University suggested that the study methods might hold “inherent biases” against larger institutions. Since HHS only requires healthcare facilities to notify the agency after detecting a PHI breach affecting 500 or more patients, smaller, targeted attacks might fall under its radar, they argued.

In response, the authors behind the original study admitted that the with the reporting level for PHI intrusions starting at 500 patients, larger hospitals were likely to show up in the analysis more often. That being said, the researchers suggested, large hospitals could easily be a more appealing target for cybercriminals because they possess “a significant amount of protected health information.”

Now, I want to repeat that I’m an analyst, not a cybersecurity expert. Still, even given my limited knowledge of data security research, the JAMA study raises some questions for me, and the researchers’ response to Vanderbilt’s challenge even more so.

Okay, sure, the researchers behind the original JAMA piece admitted that the HHS 500-patient threshold for reporting PHI intrusions skewed the data. Fair enough. But then they started to, in my view at least, wander off the reservation.

Simply saying that teaching hospitals and hospitals with more beds were more susceptible to data breaches simply because they offer big targets strikes me as irresponsible. You can’t always predict who is going get robbed by how valuable the property is, and that includes when data is the property. (On a related note, did you know that older Toyotas are far more likely to get stolen than BMWs because it’s easier to resell the parts?  When I read about that trend in Consumer Reports it blew my mind.)

Actually, the anecdotes I’ve heard suggests that the car analogy holds true for data assets — that your average, everyday cyber thief would rather steal data from a smaller, poorly-guarded healthcare organization then go up against the big guns that might be part of large hospitals’ security armament.

If nothing else, this little dispute strongly suggests that HHS should collect more detailed data breach information. (Yes, smaller health organizations aren’t going to like this, but let’s deal with those concerns in a different article.) Bottom line, if we’re going to look for data breach trends, we need to know a lot more than we do right now.

HIPAA May be the Least of Your Compliance Worries

Posted on November 21, 2017 I Written By

The following is a guest blog post by Mike Semel from Semel Consulting.  Check out all of Mike Semel’s EMR and HIPAA blog posts.

What requirements have you hidden away?

I visited a new healthcare client last week, and asked if anything in particular made them call us for help with their HIPAA compliance. They surprised me by saying that their insurance company had refused to sell them a cyber-liability/data breach insurance policy, after they saw the answers on our client’s application.

When was the last time you heard about an insurance company not selling a policy? That’s like McDonalds looking you over, and then refusing to sell you a Big Mac.

Our client was scared that they would have to risk the full financial burden of a data breach, which, based on the number of medical records they have, could exceed $10 million.

Everyone knows that HIPAA is a compliance requirement. But it isn’t the only one you should focus on. Use my definition of Compliance, which is, simply, having to do things required by OTHERS.

We personally deal with compliance requirements all the time. We stop at traffic lights. We have our car inspected. We fasten our seat belts. We empty our pockets at airport security. We pay our bills on time. At work, we wear an ID badge, show up on time, and park in an approved space. At home, we take our dirty shoes off before walking on the carpet. There are risks associated with NOT doing each of these things.

It can be a big mistake to focus so much on HIPAA that you forget other compliance requirements, including:

  • Other Federal and State Laws
  • Industry Requirements
  • License Requirements
  • Contractual Obligations
  • Insurance Requirements
  • Lawsuits

You should not take the narrow HIPAA approach, like buying a policy manual, using an online ‘We Make HIPAA Easy’ service, or think hiring out a Security Risk Analysis is going to make you compliant.

When we work with our clients, before we get started we help you identify all your compliance requirements.

OTHER FEDERAL REGULATIONS

Depending on the services you offer, you may be required to comply with other federal regulations, like Title 42, governing substance abuse treatment.

The Federal Trade Commission has come down hard on data breaches, including the controversial closure of a small medical lab. The FTC looks at patients as consumers, and considers a data breach to be an Unfair Business Practice because the organization losing the data failed to protect its consumers, and is in violation of its Notice of Privacy Practices.

STATE LAWS

Forty-eight states, plus DC and Puerto Rico, have data breach laws. Most states protect Personally Identifiable Information (PII), including driver’s license and Social Security numbers. Some states cover medical records, no matter who has them, while HIPAA only covers medical records held by certain types of organizations. Some of the state laws change the reporting requirements after a breach of patient records. For example, California requires patient notification within 15 days, instead of the 60-day maximum permitted by HIPAA.

Most states have separate laws requiring confidentiality of mental health, HIV, substance abuse, or STD treatment records. State attorneys general are willing to cross their state lines to protect the confidentiality of their voters.

We work with our clients to identify the states where your patients come from, not only where you are located. We build an Incident Management program that includes each applicable notification and reporting requirement.

INDUSTRY REQUIREMENTS

Industry requirements include PCI-DSS, the data security standards protecting credit card information. PCI stands for the Payment Card Industry. While not a law, if you don’t comply with PCI you can be prevented from accepting credit cards. What would that do to your bottom line and patient satisfaction?

LICENSING

Licensing requirements protecting patient confidentiality go back long before HIPAA, which became law in 1996. In 1977, 19 years before HIPAA, I became an Emergency Medical Technician (EMT). The first class I took was about maintaining confidentiality. After that, I knew that violating a patient’s confidentiality could cost me my license.

Think about your license, your certifications, even the Code of Ethics in your professional association. If I really wanted to get back at someone for violating my confidentiality, my first complaint would be to their licensing board, even before I submitted a complaint to their employer or the federal government. Losing your license may kill your career, and being investigated by your licensing board will certainly get your attention.

When you are justifying the costs related to Security and Compliance, be sure to quantify the effect on your income, lifestyle, and retirement, if you were to lose your license.

CONTRACTS

Many of our clients have signed contracts with other organizations, that include cyber security requirements as a contractual obligation to do business together. These contracts are often reviewed by attorneys, signed by executives, and then filed away. The requirements are not always communicated to the people on the front lines.

In 2012, Omnicell, a drug cart manufacturer, breached the records of 68,000 patients when an employee’s unencrypted laptop was stolen. The health systems – clients of Omnicell –  announced that Omnicell’s contract with them included a requirement that patient data would only be stored on encrypted devices. The loss of the laptop became a breach of contract discussion, not just a simple data breach.

My guess is that the contract was signed, and then just filed away. I don’t think Omnicell’s purchasing department was told it was supposed to order encrypted laptops for its field technicians. I don’t think its IT department knew it had a contractual obligation to install encryption on all laptops, and I doubt the field tech knew he was violating a contract when he transferred patient data to his unencrypted computer. Worse, no one who was aware of the contract requirements was auditing the company’s compliance.

During a recent client visit, I asked if our client had signed any contracts with their clients. She went through a list that included one of the top health systems in the country. I’m not a lawyer, but I asked to see the contract, because I knew the health system had included cyber security requirements as a contractual obligation with our other clients.

After a few minutes, she returned with the file folder containing the contract. I found the cyber security section, and read it to her. I asked if her company was meeting the requirements in the contract. She said no. I asked her what the future of her business would look like if they lost the business of one of the country’s leading health systems, because they breached their contract. She replied that her business probably would not survive.

We focused our project around meeting the specific requirements of their contract, not the vague and flexible requirements in HIPAA.

INSURANCE

Cyber Liability (also known as Data Breach) Insurance is a popular line of revenue for insurance companies. Unlike malpractice insurance, which assumes you will make a mistake, cyber insurance may only protect you if you are doing all the things you included on your insurance application. It may pay a claim only if you are doing everything correctly, and still suffer a breach. What you answer on the application may come back to haunt you.

In 2013, Cottage Health’s IT vendor accidently published a file server to the Internet, exposing patient information. Patients Googling themselves got back their medical records. The patients filed a class action suit, so Cottage Health brought in Columbia Casualty, their cyber liability insurance provider, to provide legal representation, and settle the claim.

The lawsuit was settled for $4.1 million, which was paid by Columbia Casualty. Columbia told Cottage Health that, even though it was making the payment, it still reserved its rights and would continue investigating the case.

Columbia Casualty then sued its own client, Cottage Health, to get the $ 4.1 million back. It said it determined that Cottage Health had made misstatements when it answered questions on the original policy application, including that it regularly maintained security patches on its devices. Columbia also said it should be excluded from losses because Cottage Health failed to continuously maintain the level of security stated on its application.

The lawsuit said that it did not matter if Cottage Health was mistaken, or had intentionally lied on the application.

As part of our assessments, we review insurance applications. When we work with our clients, we help you implement consistent programs to maintain the level of security you claim on your application.

LAWSUITS

While you don’t comply with a lawsuit, watching court cases can help you understand your risks and how to protect your organization.

Many people think that a HIPAA Notice of Privacy Practices is just a basic brochure you have to include with new patient paperwork. A patient is suing her doctor for negligence after her information was shared without her authorization. She claimed that the practice did not follow its Notice of Privacy Practices, and the Connecticut Supreme Court upheld that HIPAA can be used as a Standard of Care in a negligence suit.

Walgreen’s lost $1.44 million in a lawsuit after a pharmacist breached a customer’s confidentiality. Walgreens proved its pharmacist had received HIPAA training and had signed a confidentiality agreement. The company said it had done everything possible to prevent the breach. The jury disagreed.

By looking at law suits you can see that attorneys are using compliance requirements as the basis for claims. That can be scarier compared to the likelihood is that the federal government will make the effort to go after you.

LESSONS LEARNED

It’s really easy to focus just on HIPAA and think you are compliant. It’s also a mistake.

HIPAA is vague. It is flexible, giving you a lot of freedom to choose how to comply with the regulation. The ‘HIPAA-in-a-Box’ solutions can give you a false sense of Security and Compliance, because they are so narrowly focused.

The Federal Trade Commission can assess stronger penalties than the OCR, the federal agency that enforces HIPAA. The FTC has put businesses on 20-year monitored compliance programs. When we work with our clients, we help you create written evidence that your security policies and procedures are working.

State laws can change your patient reporting requirements. They also protect confidential information you have for your workforce members. Your Incident Management program can’t just focus on HIPAA.

Industry requirements can be very serious. Can you risk not accepting credit cards? Contact the merchant service that processes your cards to make sure you are complying with PCI-DSS.

Verify the reporting requirements of the entities that license your staff. You may have an obligation to report a breach to them, instead of waiting for someone to file a complaint.

Review the contracts you have in your files for cyber security requirements, and note any in new contracts you are about to sign. Make sure everyone in your organization who must comply with the contract requirements know about them.

You can’t buy insurance instead of doing the right things to protect data. However, if you do things right insurance may save you millions of dollars. You should review your policy application every quarter, and demand evidence from your IT department or vendor that you are in compliance with the policy requirements. Too much work? Would you rather have your insurance company fail to pay a multi-million-dollar claim?

Keep repeating to yourself, “Compliance isn’t just about HIPAA” and uncover the rest of your compliance requirements.

About Mike Semel

Mike Semel is a noted thought leader, speaker, blogger, and best-selling author of HOW TO AVOID HIPAA HEADACHES . He is the President and Chief Security Officer of Semel Consulting, focused on HIPAA and other compliance requirements; cyber security; and Business Continuity planning. Mike is a Certified Business Continuity Professional through the Disaster Recovery Institute, a Certified HIPAA Professional, Certified Security Compliance Specialist, and Certified Health IT Specialist. He has owned or managed technology companies for over 30 years; served as Chief Information Officer (CIO) for a hospital and a K-12 school district; and managed operations at an online backup company.