Blockchain is rapidly becoming the focus of conversations regarding health care disruption, and for good reason. What started out as a means for cryptocurrency is now making waves in a variety of industries, set to revolutionize how data is stored and shared.

The inability to easily and securely store and share data has long been a burden on the health system. Blockchain poses a solution to that through encryption and highly advanced technological assets which open the doors to health care innovation. Today we see blockchain being used with electronic health records (EHRs) so that a patient’s medical history is easily accessible to him/her, as well as his/her doctors, insurance providers, etc. It’s also providing the “how” in implementing value-based payment agreements, which link payment to performance of a drug or medical device. Blockchain is currently being used both in the private and public sectors, including the FDA and the CDC. While the full potential of this new technology is not yet known, the industry seems eager to find out.

Ahead of this year’s J.P. Morgan Healthcare Conference, we sat down with Lee Schneider, our top blockchain thought leader, to talk specifically about how this new technology is revolutionizing (or has the potential to revolutionize) the health care space. Continue Reading Blockchain: Health Care’s Next Great Disruptor?

Disruption of traditional health care is inevitable and poses a central challenge for health care governance. While the size and complexity of the health care industry have slowed the process of business disruption, its high costs and lack of convenience make it highly vulnerable to innovative, nontraditional competitors.

To make sure boards are well-prepared to address this challenge, McDermott Will & Emery and Kaufman Hall have partnered on a new thought leadership series designed to help you identify the signs of disruption, learn how to prepare your organization, and understand the implications for health care governance.

Get critical insights on how to spot, prepare for and manage disruption in your organization now:

  • Listen to Surviving Disruption Podcast, Episode 1: The Signs of Disruption.
  • Download Is Your Organization Disruption Ready? Questions to Assess Preparedness.
  • View our Top 5 Business Disruption Considerations for Corporate Governance infographic.
  • Watch our Behind the Scenes: The Making of the Surviving Disruption Podcast Series video.

Subscribe to the Surviving Disruption podcast on iTunesSoundCloud and Pocket Casts, and keep an eye on the Resource Center for Episode 2: The Path Through Disruption and Episode 3: A Governance Foundation, being released on December 27 and January 10.

On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims. This settlement highlights for mHealth app developers the importance of systematically gathering sufficient evidence to support their commercial claims.

Read the full article.

After three government agencies collectively created an online tool to help developers navigate federal regulations impacting mobile health apps, McDermott partner Jennifer Geetter was interviewed by FierceMobileHealthcare on the need for mobile health development tools.

Read the full article from FierceMobileHealthCare.

On December 28, 2015, the Ministry of Industry and Information Technology of China released the newly revised Classification Catalogue of Telecommunications Services, which is due to take effect as of March 1st, 2016. This round of revision has long been awaited since its last amendment in 2003, and is expected to reflect the advancement and emergence of new technologies and business models in the telecommunication field as well as to help keep new telecommunication business models under the regulatory radar.

 

Read the full China Law Alert.

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.

On Friday, February 13, 2015, the Payment Cards Industry (PCI) Security Standards Council (Council) posted a bulletin to its website, becoming the first regulatory body to publicly pronounce that Secure Socket Layers  (SSL) version 3.0 (and by inference, any earlier version) is “no longer… acceptable for protection of data due to inherence weaknesses within the protocol” and, because of the weaknesses, “no version of SSL meets PCI SSC’s definition of ‘strong cryptography.’”  The bulletin does not offer an alternative means that would be acceptable, but rather “urges organizations to work with [their] IT departments and/or partners to understand if [they] are using SSL and determine available options for upgrading to a strong cryptographic protocol as soon as possible.”   The Council reports that it intends to publish soon an updated version of PCI-DSS and the related PA-DSS that will address this issue.  These developments follow news of the Heartbleed and POODLE attacks from 2014 that exposed SSL vulnerabilities.

Although the PCI standards only apply to merchants and other companies involved in the payment processing ecosystem, the Council’s public pronouncement that SSL is vulnerable and weak is a wakeup call to any organization that still uses an older version of SSL to encrypt its data, regardless of whether these standards apply.

As a result, every company should consider taking the following immediate action:

  1. Work with your IT stakeholders and those responsible for website operation to determine if your organization or a vendor for your organization uses SSL v. 3.0 (or any earlier version);
  2. If it does, evaluate with those stakeholders how to best disable these older versions, while immediately upgrading to an acceptable strong cryptographic protocol as needed;
  3. Review vendor obligations to ensure compliance with a stronger encryption protocol is mandated and audit vendors to ensure the vendor is implementing greater protection;
  4. If needed, consider retaining a reputable security firm to audit or evaluate your and your vendors’ encryption protocols and ensure vulnerabilities are properly remediated; and
  5.  Ensure proper testing prior to rollout of any new protocol.

Additional resources and materials:

  • NIST SP 800-57: Recommendation for Key Management – Part 1: General (Revision 3)
  • NIST SP 800-52: Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) Implementations (Revision 1)

On the third anniversary of the EU Commission’s proposed new data protection regime, the UK ICO has published its thoughts on where the new regime stands. The message is mixed: progress in some areas but nothing definitive, and no real clarity as to when the new regime may come into force.

The legislative process involves the agreement of the European Commission, the European Parliament and the Council of Europe (representing the governments of the member states). So far the European Parliament has agreed its amendments to the Commission’s proposal and we are still waiting for the Council to agree it’s amendments before all three come together and try and find a mutually agreeable position.

The Council is guided by the mantra “nothing is agreed until everything is agreed”, and so even though there has been progress with the Council reaching “partial general agreement” on international transfers, risk-based obligations on controllers and processors, and the provisions relating to specific data processing situations such as research and an approach agreed on the one-stop shop principle (allowing those operating in multiple states to appointed and deal with a single authority), this progress means nothing until there is final agreement on everything. At this stage that means all informal agreements remain open to renegotiation.

It is noted that Latvia holds the presidency of the Council until June 2015. The Latvians have already noted that Anydata protection reform remains a key priority but progress has been slow and time may be against them. Where Latvia fails, Luxembourg will hopefully succeed as it takes up the presidency from June.

The ICO is urging all stakeholders to push on with the reform, although they see the proposed timetable of completion of the trilogue process by the end of 2015 as being optimistic. Instead a more reasonable timetable may be a final agreement by mid-2016 with the new regime up and running in 2018.

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission confirmed its expanded reach in the United States, and Canada’s far-reaching anti-spam legislation takes full effect imminently. As European authorities grappled with the draft data protection regulation and the “right to be forgotten,” the African Union adopted the Convention on Cybersecurity and Personal Data, and China improved the security of individuals’ information in several key areas. Meanwhile, Latin America’s patchwork of data privacy laws continues to evolve as foreign business increases.

This report furnishes in-house counsel and others responsible for privacy and data protection with an overview of key action points based on these and other 2014 developments, along with advance notice of potential trends in 2015. McDermott will continue to report on future updates, so check back with us regularly.

Read the full report here.

For those Of Digital Interest readers attending the Brand Activation Association’s (BAA) 36th Annual Marketing Law Conference, please join McDermott partner – and Of Digital Interest editor – Julia Jacobson as she moderates a panel titled “New and Unexpected: Developments in Mobile Marketing – Mobile Tracking, Apps and Mobile Payments.” She will be joined by Ira Schlussel of HelloWorld, Inc., Paul Twarog of Google Inc. and co-moderator Terese Arenth. The panel session starts at 3:20 pm on Thursday, November 6.  We hope to see you there.