The Office of the National Coordinator for Health Information Technology recently released a report (the Report) detailing user experience research on patient access to health data. The Report sought to examine the experiences of 17 individuals and processes of 50 health systems, with commentary from four medical record fulfillment administrators, to determine how the medical record request process can be improved for consumers. The Report ultimately concludes that patients and health care providers alike are in need of a well-defined process that is convenient, expedient and transparent.

Background

The Health Insurance Patient Portability and Accountability Act (HIPAA) does not create a uniform process for storage and production of medical records across providers, and in-turn did not create a convenient request process for patients. Generally, patients have a right to access a designated record set, which includes 1) medical records and billing records about individuals maintained by or for a covered health care provider; 2) enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; and 3) other records that are used, in whole or in part, by or for the covered entity to make decisions about individuals. Upon receipt of a request by a patient to access their health records, the covered entity receiving the request must produce the records within 30 days. Prior to producing those records, however, the covered entity must verify the identity of the individual making the request. This often involves signature verification or similar processes.

Continue Reading Many Lessons Still Need to be Learned regarding Patient Access to Health Care Information

Jennifer Geetter and Lisa Schmitz Mazur wrote this bylined article on the regulatory implications of technology-supported devices, resources, and solutions that facilitate health patient-provider interaction. “Health industry regulators are struggling with how to apply the existing privacy regulatory regime, and the permitted uses and disclosures for which they provide, in this new world of healthcare innovation,” the authors wrote.

Continue reading.

On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on the impermissible disclosure of unsecured electronic protected health information (ePHI) by a provider of remote mobile monitoring, with a focus on patients who are at risk for cardiac arrhythmias.

In January 2012, the remote monitoring company reported that a workforce member’s laptop containing the ePHI of over a thousand individuals was stolen from a parked vehicle outside of the employee’s home. A little over one year later, the same company reported a second breach that compromised the ePHI of twice as many individuals (details regarding this breach were not provided by OCR).

OCR’s investigation revealed that the company allegedly had insufficient risk analysis and risk management processes in place at the time of the theft. Additionally, the company’s draft policies and procedures implementing the standards of the HIPAA Security Rule had never been implemented, and the company was also unable to produce final versions of any policies or procedures regarding the implementation of safeguards for ePHI, including those for mobile devices.

Continue Reading Recent $2.5 Million OCR Settlement Is a Warning to Wireless Health Service Providers

In its tenth OCR Cyber Awareness Newsletter of the year (Newsletter), the Office for Civil Rights (OCR) reminded HIPAA-covered entities and business associates of the importance of selecting an appropriate authentication method to protect electronic protected health information (ePHI). Authentication is the process used to “verify whether someone or something is who or what it purports to be and keeps unauthorized people or programs from gaining access to information.” The Newsletter notes that the health care sector has been a significant target of cybercrime and that some incidents result from weak authentication methods.

Authentication methods can consist of one or more factors and are often described as: (1) something you know, such as a password; (2) something you are, such as a fingerprint; or (3) something you have, such as a mobile device or smart card. Single-factor authentication requires use of only one of the methods. Multifactor authentication requires use of two or more methods (for example, a password prompt followed by an additional prompt to a mobile device). Continue Reading OCR Guidance Underscores Importance of Authentication under HIPAA

On July 28, 2016, US Department of Health and Human Services (HHS) issued guidance (guidance) under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and recover from ransomware attacks. Ransomware attacks can also trigger concerns under state data breach notification laws.

The HIPAA Security Rule requires covered entities and business associates to implement security measures. It also requires covered entities and business associates to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic protected health information (ePHI) the entities create, receive, maintain or transmit and to implement security measures sufficient to reduce those identified risks and vulnerabilities to a reasonable and appropriate level. The HIPAA Security Rule establishes a floor for the security of ePHI, although additional and/or more stringent security measures are certainly permissible and may be required under state law. Compliance with HIPAA’s existing requirements provides covered entities and business associates with guidance on how to prevent and address breaches that compromise protected health information. The new HIPAA guidance specific to ransomware reinforces how the existing requirements can help an entity protect sensitive information.

Read the full article here.

With no Congressional consensus to adopt a federal data privacy and breach notification statute, states are updating and refining their already-existing laws to enact more stringent requirements for companies.  Two states recently passed updated data privacy laws with significant changes.

Rhode Island

The Rhode Island Identity Theft Protection Act (Rhode Island Data Law), an update to Rhode Island’s already-existing data security and breach notification law, introduces several new requirements for companies that store, collect, process, use or license personal identifying information (PII) about Rhode Island residents.

A few of these provisions are particularly noteworthy.  First, the new law requires entities to “implement and maintain a risk-based information security program which contains reasonable security procedures and practices,” scaled to the size of the entity and the type of personal information in its possession.  Second, the Rhode Island Data Law requires that any entity that discloses PII to a third party have a written contract with the third party pursuant to which the third party will also implement and maintain an information security program to protect the personal information.  Third, the Rhode Island Data Law requires any entity that experiences a data breach of personal information to notify affected residents within 45 calendar days after it knows that a breach has occurred.  (Rhode Island also required this under its previous law, but there was no precise time frame.)  Among other information, the notification must now contain information about data protection services to be offered to the resident, as well as information about how the resident can request a security credit freeze.

Under both the old and new laws, a health care provider, insurer or covered entity that follows the medical privacy and security rules established by the federal government pursuant to the Health Insurance Portability and Accountability Act (HIPAA) is deemed compliant with the law’s requirements.  The Rhode Island Data Law will become effective June 26, 2016.

Connecticut

The Connecticut Act Improving Data Security and Effectiveness (Connecticut Data Law) similarly updates Connecticut’s existing law and introduces more stringent requirements for entities that that store, collect, process, use or license PII about Connecticut residents.

Perhaps most noteworthy, the Connecticut Data Law puts in place important new requirements about notification following a data breach.  Unlike the older Connecticut breach notification law, the Connecticut Data Law now requires an entity to notify affected individuals of a data breach within a set time period of 90 days.  In addition, if the breach involves disclosure of Social Security numbers, the entity must also provide free credit monitoring services to individuals for one year.  Many companies provide credit monitoring at no cost to their customers affected by a data breach voluntarily.  However, laws like Connecticut’s make credit monitoring a mandatory part of any company’s response.

Additionally, the Connecticut Data Law imposes significant new requirements on insurers and state contractors that handle PII.  Health insurers are required to develop and follow a written data security program, and to certify annually to the state insurance department that it is following its written data security program.  State contractors must implement and maintain a data security program to safeguard PII and maintain the information in a secure manner as specified in the statute.

The law’s requirements regarding data breach notification become effective October 1, 2015, but insurers have until October 1, 2017 to create and implement the required written data security program.

Key Takeaways

These new laws highlight important takeaways for businesses:

  • Any business operating across multiple states must be aware of the specific requirements of state data privacy and breach laws, and updates to those laws.
  • If other states follow Rhode Island and Connecticut’s lead, state data security and breach notification requirements will continue to become more, not less, stringent.
  • Any business that collects or maintains data relating to Rhode Island or Connecticut should evaluate its own policies and procedures regarding data security and breach response, and update those procedures in light of the new requirements.

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently transmitted HIPAA pre-audit screening surveys to covered entities that may be selected for a second phase of HIPAA compliance audits (Phase 2 Audits). OCR is required to conduct compliance audits of covered entities and business associates under the 2009 Health Information Technology for Economic and Clinical Health Act.

Unlike the pilot audits conducted in 2011 and 2012 (Phase 1 Audits), which focused on covered entities, OCR is conducting Phase 2 Audits of both covered entities and business associates. The Phase 2 Audit program will focus on areas of greater risk to the security of protected health information (PHI) and pervasive non-compliance based on OCR’s Phase I Audit findings and observations, rather than a comprehensive review of all of the HIPAA Standards. The Phase 2 Audits are also intended to identify best practices and uncover risks and vulnerabilities that OCR has not identified through other enforcement activities. OCR will use the Phase 2 Audit findings to identify technical assistance that it should develop for covered entities and business associates. In circumstances where an audit reveals a serious compliance concern, OCR may initiate a compliance review of the audited organization that could lead to civil money penalties.

OCR had previously planned to issue the pre-audit screening surveys in the summer of 2014, but postponed their release until it completed its implementation of a new web portal that will be used for the submission of audit-related materials.

We will publish a fuller On the Subject regarding the Phase 2 Audits in the coming days.

On April 1, 2015, the Office of the National Coordinator for Health Information Technology (ONC), which assists with the coordination of federal policy on data sharing objectives and standards, issued its Shared Nationwide Interoperability Roadmap and requested comments.  The Roadmap seeks to lay out a framework for developing and implementing interoperable health information systems that will allow for the freer flow of health-related data by and among providers and patients.  The use of technology to capture and understand health-related information and the strategic sharing of information between health industry stakeholders and its use is widely recognized as critical to support patient engagement, improve quality outcomes and lower health care costs.

On April 3, 2015, the Federal Trade Commission issued coordinated comments from its Office of Policy Planning, Bureau of Competition, Bureau of Consumer Protection and Bureau of Economics.  The FTC has a broad, dual mission to protect consumers and promote competition, in part, by preventing business practices that are anticompetitive or deceptive or unfair to consumers.  This includes business practices that relate to consumer privacy and data security.  Notably, the FTC’s comments on the Roadmap draw from both its pro-competitive experience and its privacy and security protection perspective, and therefore offer insights into the FTC’s assessment of interoperability from a variety of consumer protection vantage points.

The FTC agreed that ONC’s Roadmap has the potential to benefit both patients and providers by “facilitating innovation and fostering competition in health IT and health care services markets” – lowering health care costs, improving population health management and empowering consumers through easier access to their personal information.  The concepts advanced in the Roadmap, however, if not carefully implemented, can also have a negative effect on competition for health care technology services.  The FTC comments are intended to guide ONC’s implementation with respect to: (1) creating a business and regulatory environment that encourages interoperability, (2) shared governance mechanisms that enable interoperability, and (3) advancing technical standards.

Taking each of these aspects in turn, creating a business and regulatory environment that encourages interoperability is important because, if left unattended, the marketplace may be resistant to interoperability.  For example, health care providers may resist interoperability because it would make switching providers easier and IT vendors may see interoperability as a threat to customer-allegiance.  The FTC suggests that the federal government, as a major payer, work to align economic incentives to create greater demand among providers for interoperability.

With respect to shared governance mechanisms, the FTC notes that coordinated efforts among competitors may have the effect of suppressing competition.  The FTC identifies several examples of anticompetitive conduct in standard setting efforts for ONC’s consideration as it considers how to implement the Roadmap.

Finally, in advancing core technical standards, the FTC advised ONC to consider how standardization could affect competition by (1) limiting competition between technologies, (2) facilitating customer lock-in, (3) reducing competition between standards, and (4) impacting the method for selecting standards.

As part of its mission to protect consumers, the FTC focuses its privacy and security oversight of health- related information on companies and data sharing arrangements that sit outside the jurisdiction of the Health Insurance Portability and Accountability Act (HIPAA), which regulates the privacy and security practices of covered entity health care providers, health plans and health care clearinghouses, as well as the third parties that assist those covered entities, referred to as business associates.  Information regulated by HIPAA, called Protected Health Information (PHI) typically resides in the “traditional medical model” of providers and health plans.  Information regulated by the FTC, often called consumer-generated health information (CHI) tends to be generated outside of the traditional medical model, for example through the explosion of wearables and other digital, consumer-facing technologies.

As interoperability gathers steam, and as providers and plans increasingly look to mobile and digital health tools to maximize patient engagement and obtain additional “out of the exam room” data that they can leverage to improve patient outcomes and control costs, the divide between PHI and CHI collapses.  Not only will interoperability have to contend with PHI-centered systems effectively sharing information with one another, but it will also have to contend with the need for systems to move PHI and CHI, consistent with the different consumer expectations and regulatory frameworks for such information.  And then, of course, there is also state law.

The FTC’s comments highlight the central role that the FTC will play, alongside the Office of Civil Rights, which enforces HIPAA, in envisioning, deploying and overseeing the health information sharing systems beginning to emerge.

As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) — through use of the internet and increasingly-popular lifestyle and fitness mobile apps is more sensitive and in need of more privacy-sensitive treatment than other consumer-generated data.

One of the key questions raised during the FTC’s CHI seminar is: “what is consumer health information”?  Information gathered during traditional medical encounters is clearly health-related.  Information gathered from mobile apps designed as sophisticated diagnostic tools also is clearly health-related — and may even be “Protected Health Information,” as defined and regulated by Health Information Portability and Accountability Act (HIPAA), depending on the interplay of the app and the health care provider or payor community.  But, other information, such as diet and exercise, may be viewed by some as wellness or consumer preference data (for example, the types of foods purchased).  Other information (e.g., shopping habits) may not look like health information but, when aggregated with other information generated by and collected from consumers, may become health-related information.  Information, therefore, may be “health information,” and may be more sensitive as such, depending on (i) the individual from whom it is collected, (ii) the context in which it is initially collected; (iii) the other information which it is combined; (iv) the purpose for which the information was initially collected; and (v) the downstream uses of the information.

Notably, the FTC is not the only regulatory body struggling with how to define CHI.  On February 5, 2015, the European Union’s Article 29 Working Party (an EU representative body tasked with advising EU Member States on data protection) published a letter in response to a request from the European Commission to clarify the definitional scope of “data concerning health in relation to lifestyle and wellbeing apps.”

The EU’s efforts to define CHI underscore the importance of understanding CHI.  The EU and the U.S. data privacy and security regimes differ fundamentally in that the EU regime broadly protects personally identifiable information.  The US does not currently provide universal protections for personally identifiable information.  The U.S. approach varies by jurisdiction and type of information and does not uniformly regulate the mobile app industry or the CHI captured by such apps.  These different regulatory regimes make the EU’s struggle to define the precise scope and definition of “lifestyle and wellbeing” data (CHI) and develop best practices going forward all the more striking because, even absent such a definition, the EU privacy regime would offer protections.

The Article 29 Working Party letter acknowledges the European Commission’s work to date, including the European Commission’s “Green Paper on Mobile Health,” which emphasized the need for strong privacy and security protections, transparency – particularly with respect to how CHI interoperates with big data  – and the need for specific legislation on CHI-related  apps or regulatory guidance that will promote “the safety and performance of lifestyle and wellbeing apps.”  But, in its annex to the Article 29 Working Party letter, the Working Party notes: “due to the wide range of personal data that may fall into the category of health data, this category represents one of the most complex areas of sensitive data and …display[s] a great deal of diversity and legal uncertainty.”    Thus, even within the more protective EU data privacy regime, regulators acknowledge the likely need for specific privacy and security protections in light of the consumer-driven nature of CHI, the myriad mechanisms in which such data is collected and aggregated in the digital landscape, and the difficulty in tracing, tracking and predicting how such data will be aggregated, disaggregated and otherwise used.

As a starting point, the annex to the Article 29 Working Party letter presents a framework for determining when personal data are health data, which is:

  1. “The data are inherently/clearly medical data.
  2. The data are raw sensor data that can be used in itself or in combination with other data to draw a conclusion about the actual health status or health risk of a person.
  3. Conclusions are drawn about a person’s health status or health risk (irrespective of whether these conclusions are accurate or inaccurate, legitimate or illegitimate, or otherwise adequate or inadequate).”

The Annex also notes the importance of obtaining “the unambiguous consent of the data subject,” given that many CHI-related mobile apps collect and process location data and data collected through sensors, which, when combined with other data, could identify a  person’s health status.

Back in the United States, the FTC continues to signal its interest in mobile applications that collect and analyze CHI.  On February 23, 2015, the FTC released a pair of consent orders about two different mobile applications, alleging that the apps did not perform as advertised.  Although these consent orders do not expressly address the data privacy implications of the apps, they signal that the FTC is monitoring the representations that apps collecting and using CHI are making to consumers.

As mobile apps become more sophisticated and assist patients and providers with the active detection and management of health conditions, we expect that the need for clarity and consensus about reasonable data privacy and protection practices with respect to CHI will intensify because this need for clarity and consensus is something about which both U.S. and EU regulators can agree.

In the wake of recent breaches of personally identifiable information (PII) suffered by health insurance companies located in their states, the New Jersey Legislature passed, and the Connecticut General Assembly will consider legislation that requires health insurance companies offering health benefits within these states to encrypt certain types of PII, including social security numbers, addresses and health information.  New Jersey joins a growing number of states (including California (e.g., 1798.81.5), Massachusetts (e.g., 17.03) and Nevada (e.g., 603A.215)) that require organizations that store and transmit PII to implement data security safeguards.   Massachusetts’ data security law, for example, requires any person or entity that owns or licenses certain PII about a resident of the Commonwealth to, if “technically feasible” (i.e., a reasonable technological means is available), encrypt information stored on laptops and other portable devices and encrypt transmitted records and files that will travel over public networks.  Unlike Massachusetts’ law New Jersey’s new encryption law only applies to health insurance carriers that are authorized to issue health benefits in New Jersey (N.J. Stat. Ann. §  56:8-196) but requires health insurance carriers to encrypt records with the PII protected by the statute when stored on any end-user systems and devices, and when transmitted electronically over public networks (e.g., N.J. Stat. Ann. § 56.8-197).

At the federal level, the Health Insurance Portability and Accountability Act (HIPAA) already requires health plans, as well as other “covered entities” (i.e., health providers)  and their “business associates” (i.e., service providers who need access to a covered entity’s health information to perform their services), to encrypt stored health information or health information transmitted electronically if “reasonable and appropriate” for them to do so (45 C.F.R. §§ 164.306; 164.312).  According to the U.S. Department of Health and Human Services, health plans and other covered entities and their business associates should consider a variety factors to determine whether a security safeguard is reasonable and appropriate, including: (1) the covered entity or business associate’s risk analysis; (2) the security measures the covered entity or business associate already has in place; and (3) the costs of implementation (68 Fed. Reg. 8336).  If the covered entity or business associate determines that encryption of stored health information or transmitted information is not reasonable and appropriate, however, the covered entity or business associate may instead elect to document its determination and implement an equivalent safeguard.

The New Jersey law and the Connecticut proposal appear to reflect a legislative determination that encryption of stored or transmitted health information is always reasonable and appropriate for health plans to implement, regardless of the other safeguards that the health plan may already have in place.  As hackers become more sophisticated and breaches more prevalent in the health care industry, other states may follow New Jersey and Connecticut by expressly requiring health plans and other holders of health care information to implement encryption and other security safeguards, such as multifactor authentication or minimum password complexity requirements.  In fact, Connecticut’s Senate Democrats have indicated that their proposal will address user authentication protocol requirements, in addition to encryption.  We will continue to monitor Connecticut’s legislative proposal and track additional developments in state data security laws during this year’s legislative sessions.