The need for speedy and more complete access to data is instrumental for healthcare providers, researchers, pharmaceutical, biotech and device companies and public health authorities as they work to quickly identify infection rates, disease trends, outcomes, including antibodies, and opportunities for treatments and vaccines for COVID-19.

A variety of data sharing and collaborations have emerged

Digital health companies are producing increasingly innovative products at a rapidly accelerating pace, fueled in large part by the expansive healthcare data ecosystem and the data strategies for harnessing the power of that ecosystem. The essential role data strategies play make it imperative to address the data-related legal and regulatory considerations at the outset of the innovation initiative and throughout the development and deployment lifecycle so as to protect your investment in the short and long term.

The Evolution of Digital Health

Digital health today consists of four key components: electronic health records, data analytics, telehealth, and patient and consumer engagement tools. Electronic health records were most likely first, followed very closely by data analytics. Then telehealth deployment rapidly increased in response to both demand by patients and providers, the improved care delivery and access it offers, and more recently, the expanded reimbursement for telehealth solutions. Each component of digital health was developed somewhat independently, but they have now converged and are interrelated, integral parts of the overall digital health ecosystem.

The patient and consumer engagement dimension of digital health has exploded over the last five years. This is due, in large part, to consumer and patient demand for greater engagement in the management of their healthcare, as well as the entry of disruptors, such as technology service providers, e-commerce companies, consumer products companies and entrepreneurs. At this point in the evolution of the digital health landscape, the patient and consumer engagement tool dimension pulls in all other key components and no digital health consumer engagement tool is complete without the full package.

Data Strategies and Collaborations as Key Innovation Ingredients

No digital health initiative can be developed, pursued or commercialized without data. But the world of data aggregation and analytics has also changed significantly and become immensely complex in recent years. Digital health innovation is no longer working exclusively within the friendly confines of the electronic health record and the carefully regulated, controlled and structured data it holds. Today, digital health innovation relies on massive amounts of data in a variety of types, in various forms, from a wide variety of sources, and through a wide variety of tools, including patient and consumer wearables and mobile devices.


Continue Reading Consumer Demand in Digital Health Data and Innovation

With the California Consumer Privacy Act of 2018 (CCPA) having taken effect on January 1, 2020, the privacy and data security landscape for insurance carriers, producers and insurtech (collectively, “insurers”) continues to grow more complex. A number of states have also recently passed laws regulating data security in the insurance industry, with the first transition period under a number of these laws set to end in 2020. Given the significant amount of sensitive personal information that insurers collect, process and retain, this trend of increased privacy and data security regulation within the insurance industry is likely to continue. To stay ahead of these new privacy and data security requirements, insurers need to take steps now to navigate the increasingly complex regulatory landscape.

How Does the CCPA Impact Insurers?

On January 1, 2020, California became the first state in the United States to enact comprehensive privacy legislation that governs the collection, use and sale of personal information of California residents (i.e., consumers) and households. Personal information is broadly defined as any information that identifies, relates to, describes is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular individual or household. The CCPA applies to “businesses,” which are for-profit entities that determine the purposes and means of processing consumers’ personal information that do business in California and meet certain applicability thresholds.

Insurers operating in California that meet the CCPA applicability thresholds will be deemed “businesses” subject to a number of obligations under the CCPA, including disclosure obligations and requirements related to consumer privacy rights. While these obligations can be quite onerous, the vast majority of personal information that many personal line insurers collect, process and retain will likely fall under an exemption in the CCPA. The CCPA includes exemptions for:


Continue Reading Privacy and Data Security: 2020 Considerations for the Insurance Industry

The demand for healthcare innovation is driving collaboration between formerly disparate healthcare companies and bringing in new players, such as technology companies and start-ups, into an already complex space. As companies build partnerships and pool resources – particularly healthcare data – data ownership presents numerous challenges that need to be addressed throughout the lifecycle of

The digitization of health care and the proliferation of electronic medical records is happening rapidly, generating large quantities of data with potential to provide valuable insights into disease and wellness and help solve challenging public health problems.

There is tremendous enthusiasm over the possibilities of leveraging this data for secondary use–i.e., a use

Lack of a sufficient risk analysis continues to be one of the most commonly alleged violations in Office for Civil Rights (OCR) HIPAA enforcement actions, appearing in half of all OCR settlements announced in the last 12 months and in almost all of the $1 million-plus settlements during that time period. Significant confusion remains across

Fortune’s April 2018 cover story, “Tech’s Next Big Wave: Big Data Meets Biology,” conveys loudly and clearly that technological innovation is transforming the health care continuum—changing the way care is delivered, as well as how patients manage their ongoing health—and as patient demand for health innovation increases, more companies seem eager to hop on

Last week, the US Court of Appeals for the DC Circuit issued a long-awaited decision on an omnibus challenge to the FCC’s interpretation of the TCPA. While the decision provides some relief for businesses, it does not eliminate the prospect of TCPA liability and leaves important TCPA interpretive questions unresolved. Businesses should continue to be

Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing

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