Stay current on changes and developments in corporate law with a wide variety of resources and tools.
By Jodi G. Daniel
Health information is among the most sensitive and valuable data about us, yet more and more health information is outside federal privacy law protection, and companies have few or no limitations on how this data can be used or shared.
The Department of Health and Human Services (HHS) is preparing to release new regulations to promote interoperability and patient access to data, and more companies than ever before are collecting and using data to power advanced data analytics, artificial intelligence, and machine learning to improve health care treatment and customer service. Federal policies and private sector practices should protect individuals’ interests as all stakeholders consider appropriate use of health data.
Eighteen years ago, the HIPAA Privacy and Security Rules aimed to address many concerns around “protected health information” (PHI) in health care settings that were just starting to embrace electronic data. The Privacy Rule required covered entities and their business associates to limit the use and disclosure of PHI, and to provide patients with certain rights, including access to their own information.
HIPAA does not address the handling of PHI by other entities, typically referred to as “non-covered entities,” including many new consumer health technology companies (and even some healthcare providers who don’t accept insurance). Limited protections exist for data held by these entities under current state and federal law.
As the health care industry changes rapidly and the federal government pushes toward increased interoperability and greater patient access to data, it is important to balance data portability and consumer protections.
With an estimated 86.7 million U.S. consumers owning wearable devices by 2019, patients are generating billions of data points that provide insight into their health. Yet many of these companies are not subject to existing privacy protections under HIPAA.
While many non-covered entities are transparent about their data uses, their long and detailed privacy policies are not read or understood by most consumers. HHS tried to address this issue by publishing a Model Privacy Notice to provide a simple, user-centered design approach for communicating complex privacy information. In 2016, HHS released a report concluding that significant gaps in regulatory oversight exist between covered and non-covered entities. Some of these challenges include:
Innovators are increasingly acquiring large quantities of health information to power machine learning to make new health care products and services. These health datasets are a target for those who wish to make money off of the data and for those that see an opportunity to threaten national security. Health care data is too fluid, and too valuable, to protect only when it resides with a particular data holder. Reasonable baseline privacy protections for all health information will engender greater trust in the health technology sector.
Different approaches to address these gaps include:
The first three options require legislative action.
In the meantime, baseline privacy and security best practices for any entity that holds identifiable health data may be helpful. For example:
Many of these concepts have their roots in existing federal laws or the Fair Information Practices Principles. They could help build trust and they would not prevent innovation. Industry established policies can guide industry action or be relied upon or referenced by policy-makers.
Jodi G. Daniel is a partner in Crowell & Moring’s Health Care Group in Washington, D.C., and a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She leads the firm’s Digital Health Practice and was formerly the founding director of the Office of Policy in the Office of the National Coordinator for Health Information Technology at HHS.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)