Registration to the Privacy Summit is open.

Fox Rothschild’s Minneapolis Privacy Summit on November 8 will explore key cybersecurity issues and compliance questions facing company decision-makers. This free event will feature an impressive array of panelists drawn from cybersecurity leaders, experienced regulatory and compliance professionals and the Chief Division Counsel of the Minneapolis Division of the FBI.

Attendees receive complimentary breakfast and lunch, and can take advantage of networking opportunities and informative panel sessions:

GDPR and the California Consumer Privacy Act: Compliance in a Time of Change

The European Union’s General Data Protection Regulation has been in effect since May. Companies that process or control EU citizens’ personal data should understand how to maintain compliance and avoid costly fines. Health care businesses should also prepare for the next major privacy mandate: the California Consumer Privacy Act.

Risk Management – How Can Privacy Officers Ensure They Have the Correct Security Policies in Place?

Panelists offer best practices for internal policies, audits and training to help maintain protected health information (PHI), personally identifiable information (PII) or other sensitive data. Learn the cutting edge strategies to combat the technology threats of phishing and ransomware.

Fireside Chat

Jeffrey Van Nest, Chief Division Counsel of the Minneapolis Division of the FBI, speaks on the state of affairs in regulation and enforcement; including how to partner with the FBI, timelines of engagement and the latest on cyber threat schemes. His insights offer details on forming effective cyber incident response plans.

Keynote Speaker – Ken Barnhart

Ken is the former CEO of the Occam Group, a cybersecurity industry advisor and the founder and principal consultant for Highground Cyber – a spin-off of the Occam Group’s Cybersecurity Practice Group. For more than a decade, he has helped companies of all sizes design, host and secure environments in private, public and hybrid cloud models. Prior to his work in the corporate sector, Ken served as a non-commissioned officer in the United States Marine Corp and is a decorated combat veteran of Operation Desert Shield\Storm with the HQ Battalion of the 2nd Marine Division.

Geared toward an audience of corporate executives, in-house chief privacy officers and general counsel, the summit will provide important take-aways about the latest risks and threats facing the health care industry.

Stay tuned for more agenda details. Registration is open.

Last week, I blogged about a recent U.S. Department of Health and Human Services Office of Civil Rights (OCR) announcement on its push to investigate smaller breaches (those involving fewer than 500 individuals).   The week before that, my partner and fellow blogger Michael Kline wrote about OCR’s guidance on responding to cybersecurity incidents.  Today, TechRepublic Staff Writer Alison DeNisco addresses how a small or medium sized business (MSB) can deal with the heightened threat of OCR investigations or lawsuits emanating from a security breach.  Alison’s piece, “Security breaches:  How small businesses can avoid a HIPAA lawsuit”, is must-read for MSBs struggling to understand and prioritize their cybersecurity needs.

Michael and I spoke with Alison about the recent OCR pronouncements, and she pulled several of our comments together to create a list of tips for an SMB to consider to minimize HIPAA security breach headaches. The following 6 tips are excerpted from the full article:

  1. Hire a credible consultant to help you approach the issue, and how you would respond in the event of a breach. [In other words, perform your own security risk assessment, or, if impractical, hire an expert to perform one.]
  2. Document that you have policies and procedures in place to fight cyber crime. “If you didn’t document it, it didn’t happen,” Kline said.
  3. Stay informed of cybersecurity news in your industry, or join an association. Be aware of what other companies in your space are doing to protect themselves.
  4. Update your security settings on a regular basis, perhaps every time you add new employees or change systems, or on an annual basis.
  5. Present annually to your company board on where the company is in terms of cybersecurity protection, and where it needs to be to remain as safe as possible in the future.
  6. If you’re an IT consultant working with a healthcare organization, be clear with your client what you need to access and when, Litten said. “A client that has protected health information in its software should carefully delineate who has access to that software,” she added.

The article also quotes Ebba Blitz, CEO of Alertsec, who offers an equally important tip for the SMB dealing with employees’ use of mobile devices that contain or are used to transmit PHI:

“You need a good plan for mitigating BYOD,” Blitz said. She further recommends asking employees to document their devices, so businesses can keep track of them and install security tools.”

In summary, confronting ever-growing and evolving challenges of cybersecurity for SMBs is dependent upon serious planning, development and implementation of current policies and procedures, documentation of cybersecurity measures taken and entity-wide commitment to the efforts.

The private sector is still not prepared – and generally lacks the knowledge – to respond effectively to a major cyber breach, according to 80 percent of respondents in a survey released by Fox Rothschild LLP.

“There is an alarming lack of awareness at the senior level when it comes to data governance practices in the private sector” said Fox partner Scott Vernick, who chairs the firm’s data security and privacy practice.

In its survey of cybersecurity professionals and risk experts across insurance, legal and other industries, Fox found that despite companies’ pouring real money and resources into data security:

  • 65 percent said the private sector is only “somewhat prepared” to respond to a data breach;
  • 15 percent stated it is “not prepared” at all; and
  • Only 20 percent said the private sector is “very prepared.”

The survey’s 75 respondents also expressed significant concern about senior management’s understanding of how data is, and can be, vulnerable. In fact, more than 85 percent said senior business leaders could “not accurately” or only “somewhat accurately” identify and address their companies’ data collection and storage practices.

“Companies in all sectors need to understand what types of data they collect, who has access to it and how it is stored well before a breach takes place,” Vernick added. “If they don’t follow best practices, it will cripple their ability to respond effectively and lead to costly litigation.”

In the debate over encryption and “access to data,” 84 percent of the Fox survey respondents favored the private sector’s right to guard customer data against government access in the event data was encrypted and otherwise not accessible. Nearly 75 percent also believe the private sector should be permitted to tell customers when the government subpoenas their data.

Survey respondents cited the following areas as requiring the most improvement by the private sector when it relates to cybersecurity strategy:

  • Employee training (29 percent);
  • Vendor management (24 percent);
  • Security and protection of systems, networks, firewalls and applications (19 percent);
  • Funding and resources (19 percent);
  • Encryption of data (5 percent); and
  • BYOD security (4 percent).

Perhaps the health care industry has a cybersecurity solution staring us in the face:  vaccines.  Perhaps we should be trying to vaccinate our data storage systems rather than relying on firewalls to quarantine them.  In an article posted on www.philly.com, Associated Press author Youkyung Lee says cybersecurity defense has traditionally been based “on the idea that computers could be protected by a digital quarantine.” Instead, posits Lee, experts need to focus on neutralizing attackers once they get inside a data system, rather than continuing the often-futile attempt to keep them out of the system.

Sounds like a digital vaccination to me.  According to the Centers for Disease Control, the United States is facing a multi-state measles outbreak associated primarily with unvaccinated individuals, and much has been written about parents who refuse to vaccinate their children and thereby unnecessarily and irresponsibly expose others to risk of infection.  When it comes to protecting the safety and wellbeing of protected health information and personal data maintained in a computer system, perhaps the vaccination approach is the way to go.

I turned to www.vaccines.gov for a quick description of how vaccines work in the human body.  Under “Mounting an Immune Response”, the site describes the skin in a way that makes it sound like a computer system’s firewall – it “provides an imposing barrier to invading microbes.  It is generally penetrable only through cuts or tiny abrasions.”  The digestive and respiratory tracts also work like firewalls, using acids and respiratory reflexes (coughs and sneezes) to destroy or expel invading microbes.  If the invading microbes succeed in crossing the body’s natural firewalls, the body’s immune system will kick in to thwart invading bacteria, viruses and parasites.  That’s where vaccines become helpful:

“Vaccines consist of killed or modified microbes, parts of microbes, or microbial DNA that trick the body into thinking an infection has occurred.  A vaccinated person’s immune system attacks the harmless vaccine and prepares for invasions against the kinds of microbe the vaccine contained.  In this way, the person becomes immunized against the microbe:  if re-exposure to the infectious microbe occurs, the immune system will quickly recognize how to stop the infection.”

The HIPAA Security Rule also seems to reflect a “digital quarantine” or firewall approach when it comes to implementing technical safeguards, describing implementation of access control, authentication procedures, and transmission security. (However, the requirement that covered entities and business associates implement audit controls that “record and examine activity in information systems that contain or use electronic protected health information” sounds a bit like the first step needed to develop an effective vaccine against hackers.)

So, since efforts to thwart hackers by using a “digital quarantine” (Lee’s description) or firewall type of barrier have been about as successful as relying on hand-washing and avoidance of theme parks to thwart measles, let’s hope cyber experts start to focus on developing digital vaccines.  These vaccines could not only train data systems to detect and stop a hacker after it has entered the system and before it can damage, remove, or copy the data, but also perhaps even trap the virus or other hacking mechanism for identification, analysis, and law enforcement purposes.

The Connecticut Supreme Court handed down a decision in the case of Byrne v. Avery Center for Obstetrics and Gynecology, P.C., — A.3d —-, 2014 WL 5507439 (2014) that

[a]ssuming, without deciding, that Connecticut’s common law recognizes a negligence cause of action arising from health care providers’ breaches of patient privacy in the context of complying with subpoenas, we agree with the plaintiff and conclude that such an action is not preempted by HIPAA and, further, that the HIPAA regulations may well inform the applicable standard of care in certain circumstances.

Interestingly, the decision is dated November 11, 2014, the federal holiday of Veterans Day, but was available on Westlaw on November 7, 2014.  The Court’s decision was rendered 20 months after the date that the case was argued on March 12, 2013.

The decision adds the Connecticut Supreme Court to a growing list of courts that have found that HIPAA’s lack of a private right of action does not necessarily foreclose action under state statutory and common law.  The Byrne case, however, has added significance, as it appears to be the first decision by the highest court of a state that says that state statutory and judicial causes of action for negligence, including invasion of privacy and infliction of emotional distress, are not necessarily preempted by HIPAA.  Moreover, it recognized that HIPAA may be the appropriate standard of care to determine whether negligence is present.

The Byrne case has important implications for HIPAA matters beyond the rights of individuals to sue under state tort law, using HIPAA regulations as the standard of care.  For example, in the area of business associate agreements (“BAAs”) and subcontractor agreements (“SCAs”), as was discussed in a posting in October 2013 on this blog relating to indemnification provisions,

there should be a negation of potential third party beneficiary rights under the BAA or SCA. For example, HIPAA specifically excludes individual private rights of action for a breach of HIPAA – a [p]arty does not want to run a risk of creating unintentionally a separate contractual private right of action in favor of a third party under a[n indemnification] [p]rovision.

A party should, therefore, endeavor to limit the number of persons that may assert a direct right to sue for indemnification resulting from a breach of a BAA.  Failing to limit the number of persons that may assert a direct right to sue for indemnification resulting from a breach of a BAA or SCA can be costly indeed, especially if the number of states that follow the Byrne case principles increases.

Efforts to use HIPAA regulations as standards for causes of action under state law can be expected to rise as a result of the Byrne decision.  Covered entities, business associates and subcontractors should consider acquiring sufficient cybersecurity insurance with expanded coverage and limits.

Innovative health care-related technology and developing telemedicine products have the potential for dramatically changing the way in which health care is accessed.  The Federation of State Medical Boards (FSMB) grappled with some of the complexities that arise as information is communicated electronically in connection with the provision of medical care and issued a Model Policy in April of 2014 to guide state medical boards in deciding how to regulate the practice of “telemedicine”, a definition likely to become outdated as quickly as the next technology or product is developed.

Interestingly, the development and use of medical devices and communication technology seems to outpace agency definitions and privacy laws as quickly as hackers outpace security controls.  So how can we encourage innovation and adopt new models without throwing privacy out with the bathwater of the traditional, in-person patient-physician relationship?  A first step is to see and understand the gaps in privacy protection and figure out how to they can be narrowed.

HIPAA does not protect all information, even when the information is clearly health information and a specific individual can be identified in connection with the health information.   A guidance document issued jointly by the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) on October 2, 2014 (FDA Guidance Document) contains the agencies’ “non-binding recommendations” to assist the medical device industry with cybersecurity.  The FDA Guidance Document defines “cybersecurity” as “the process of preventing unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.”  If my medical device creates, receives, maintains, or transmits information related to my health status or condition, it’s likely I expect that information to be secure and private – but unless and until my doctor (or other covered entity or business associate) interfaces with it, it’s not protected health information (PHI) under HIPAA.

The FSMB’s Model Policy appropriately focused on the establishment of the physician-patient relationship.  In general, HIPAA protects information created, received, maintained or transmitted in connection with that relationship.  A medical device manufacturer, electronic health application developer, or personal health record vendor that is not a “health care provider” or other covered entity as defined under HIPAA, and is not providing services on behalf of a  covered entity as a business associate, can collect or use health-related information from an individual without abiding by HIPAA’s privacy and security obligations.  The device, health app, or health record may still be of great value to the individual, but the individual should recognize that the information it creates, receives, maintains or transmits is not HIPAA-protected until comes from or ends up with a HIPAA covered entity or business associate.

The FDA Guidance Document delineates a number of cybersecurity controls that manufacturers of FDA-regulated medical devices should develop, particularly if the device has the capability of connecting (wirelessly or hard-wired) to another device, the internet, or portable electronic media.  Perhaps these controls will become standard features of medical devices, but they might also be useful to developers of other types of health-related products marketed to or purchased by consumers.  In the meantime, though, it’s important to remember that your device is not your doctor, and HIPAA may not be protecting the health data created, received, maintained or transmitted by your medical device.