General Interest
Subscribe to General Interest's Posts

State Privacy Patchwork Spreads with Signing of Colorado Privacy Act

On July 7, 2021, Colorado Governor Jared Polis signed the Colorado Privacy Act (CPA) into law, the latest in the recent wave of state privacy legislation but unlikely to be the last. The CPA will take effect July 1, 2023, six months after Virginia’s Consumer Data Protection Act (CDPA) and the California Privacy Rights Act (CPRA) become effective. Organizations subject to the new Colorado law will have to prepare for new consumer rights and restrictions with respect to Colorado consumers’ personal data. What follows are key takeaways from the CPA and the implications for businesses grappling with the changing privacy landscape in the US.

Applicability and Exemptions

Not all organizations will be covered by the new CPA. To be subject to the law, an organization must do business in Colorado and meet one of the following requirements:

  • The organization processes data on 100,000 or more Colorado consumers annually.
  • The organization processes data on 25,000 or more Colorado consumers annually and “sells” any personal data.

This applicability threshold sets a relatively high bar, and many companies that are subject to the California Consumer Privacy Act of 2018 (CCPA)/CPRA may not meet these thresholds in Colorado.

There are a number of exemptions and limitations built into the Colorado law. Personal data regulated under existing federal privacy regimes, such as the Health Insurance Portability and Accountability Act (HIPAA), will be exempt from the CPA, as will personal data about employees and others “acting in a commercial or employment context.” Further, the CPA’s substantive requirements will not limit organizations’ ability to process data for legal compliance, fraud prevention, security, contract fulfillment or any “internal operations that are reasonably aligned with the expectations of the consumer based on the consumer’s existing relationship” with the organization.

Substantive Rights Largely Mirror Other State Privacy Laws

The CPA establishes a number of substantive rights that Colorado consumers will have with respect to their personal data. In general, these rights mirror those in the existing laws in California and Virginia, including the following:

  • Notice. Covered organizations will be required to disclose data collection and processing details in their public-facing privacy policies. In addition, a new “duty of purpose specification” requires that companies identify the “express purposes for which personal data are collected and processed.” Whether existing privacy policies are sufficiently “express” for these purposes will be an important consideration for organizations under the CPA and one that will likely lead to both confusion and potential regulation in the future.
  • Access, Correction and Deletion. Consumers will have the right to access, correct and delete their personal data. For the right to access, businesses will be required to provide data in a portable format where feasible.
  • Opt Out. Consumers have the ability to opt out of data “sales,” targeted advertising and high-risk automated “profiling.”
  • Opt In. As with the CDPA, businesses must seek opt-in consent before collecting or processing “sensitive personal data,” which includes data revealing an individual’s race, ethnicity, religious beliefs, [...]

    Continue Reading



read more

Future Forward: Data Arrangements During and After COVID-19

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 in the wake of this crisis, such as:

  • Requests and mandates by public health authorities, either directly or via providers’ business associates requesting real time information on infections and bed and equipment availability
  • Data sharing collaborations among providers for planning, anticipating and tracking COVID-19 caseloads
  • Data sharing among providers, professional societies and pharmaceutical, biotech and medical device companies in search of testing options, treatment and vaccine solutions, and evaluation of co-morbidities

CLICK HERE TO VIEW THE FULL INFOGRAPHIC.




read more

Florida’s Extension of its COVID-19 Out-of-State Provider Waiver: A Sign of the Times

Background: Issuing Florida’s Emergency Order

On March 16, 2020, Florida Surgeon General Dr. Scott Rivkees signed, stamped and finalized Emergency Order 20-002. In doing so, Florida joined what would become the vast majority of states in modifying licensure requirements for physicians in response to the Coronavirus (COVID-19) emergency.

The surgeon general’s order waived licensing requirements for out-of-state healthcare professionals, advanced life support professionals and basic life support professionals so that they could render services in Florida for the purposes of preparing for, responding to and mitigating any effect of COVID-19. In addition to waiving licensing requirements for in-person services, the order exempted out-of-state physicians, osteopathic physicians, physician assistants and advanced practice registered nurses from licensing requirements governing the provision of telehealth. The order also impacted emergency medical services training programs, physical examination requirements for physician certifications, prescription drug distribution and controlled substance prescription renewals (including medical marijuana). The order was to expire 30 days after signing—April 15, 2020.

(more…)




read more

Coronavirus Resource Center | Preparedness Planning for Businesses

In our global economy, Coronavirus (COVID-19) raises serious concerns for employers in all industries. Workers may be on the front lines caring for patients and developing vaccines, travelling for business, or in close contact with individuals who travel or may have been affected. At this time, there is no vaccine or medication approved to prevent or treat the COVID-19 disease. Therefore, preparedness and prevention are crucial. Frontline responders must be especially vigilant as they deliver care and anticipate the challenges this uncharted territory presents.

McDermott’s Coronavirus Resource Center, brought to you by a multi-disciplinary team, will keep you informed of the latest developments and provide comprehensive insight to help you navigate this crisis with your employees, including:

  • Frequently asked questions for US and multi-national employers
  • Recent news updates
  • Podcasts
  • Upcoming events

Click here to access the Resource Center.




read more

Consumer Demand in Digital Health Data and Innovation

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.

(more…)




read more

Maximizing Your IP Protections in Digital Health

Digital health is experiencing a boom in investment as the regulatory environment becomes more supportive of digital health services. But as companies seek to make the most of their funding and protect the innovations that drive their product, it is imperative that they protect their intellectual property from being copied or duplicated by others in the market.

What exactly is IP?

Intellectual Property (IP) is generally non-tangible property. You can hold your laptop in your hands or you can stand on a piece of land — those are both tangible examples of property. Intellectual property cannot be physically held or touched. Protections available for intellectual property generally break down into one of four areas: patents; trade secrets, trademark, and copyright.

Patent protection offers an additional layer of protection for digital health solutions compared to copyrights. For example, a company may be eligible for a patent if it has innovated a new approach to identifying data, a new approach to storing data more efficiently, or a new approach to the data structure itself—those are all ways where innovations could be patentable and help extend protection around data.

How does IP apply to data?

If, in a digital health patent application, a company focuses on innovation for a computer-specific problem—such as keeping data private, keeping data secure, de-identifying data—that is usually a homerun argument to the patent office for crossing the first threshold of eligibility for patenting.

This is one of the few areas where the patent office has made it clear that these ideas and invention types are considered patent eligible. Thereafter, of course, remains the traditional challenge of getting a patent, which is to prove that no one before you has invented what you’ve invented. But lately, in the digital health space, that challenge seems to be less difficult to overcome compared to the eligibility challenge.

How to protect IP

(more…)




read more

New Podcast | Protecting Your Tech: IP Considerations in Digital Health

Digital health companies are producing innovative products at a rapidly accelerating pace and experiencing a boom in investments and demand as the regulatory environment becomes more supportive of digital health services to both improve patient care and stay profitable. Protecting intellectual property (IP) and building a feasible data strategy to support the research and development endeavor are essential steps for companies in their drive toward commercialization and return on their investment. On this episode of the Of Digital Interest podcast, McDermott partners Bernadette Broccolo (Health) and Ahsan Shaikh (IP), explore key issues for digital health companies, their collaboration partners and investors, and start-ups to consider, including:

  • What is currently patent eligible in the digital health space?
  • What patent-eligible trends and opportunities are we seeing?
  • How do laws governing data sharing among digital health collaborators impact the research and development effort and associated IP rights?
  • What challenges and opportunities do artificial intelligence, blockchain and machine learning present for digital health innovators?

Listen now




read more

Digital Health Business Strategy: A Careful Balance

When it comes to market success for digital tools in the health sector, business strategy can be far more complex than in other industries. Understanding customer-driven market trends is important, but healthcare’s complexity can camouflage customer demand and its regulatory ecosystem adds layers of additional considerations.

Customer Demand and Digital Solutions

The convenience, competitive pricing, answers-at-your-fingertips responsiveness and hyper-personalization delivered by top technology brands and their integration into other industry sectors has created an expectation for digital health solutions that deliver the same experience.

In some instances, consumers are finding the solutions. For example, telemedicine is gaining momentum as consumers discover that digital interactions with high-quality providers are oftentimes more convenient and less expensive than face-to-face encounters. Other tools are providing access to prescriptions, better health condition management solutions, better information sharing enabling smoother transitions among care settings, and more efficiency in everything from hospital operations to scheduling appointments to identifying in-network care options.

When it comes to business strategy, however, digital health solutions need to recognize that consumer pressures are frequently at odds with existing incentives within care delivery systems and, perhaps legal and regulatory requirements. Accordingly, it is critical not just from a compliance perspective but also from a business strategy perspective to navigate the healthcare industry’s unique market and regulatory dynamics.

Balancing Demand with Reality
(more…)




read more

New Podcast | 2020 Digital Health Outlook: Thoughts from CES and JPM

The digital health space had a strong start to 2020 with two of the industry’s largest conferences leading the conversation on what’s to come for digital health companies, deals, products and the regulatory outlook in the coming year. The Consumer Electronics Show (CES) launched its Digital Health programming track in Las Vegas this year and the J.P. Morgan Healthcare Conference continued to bring thousands of healthcare investors from numerous sectors together in San Francisco.

On this episode of the Of Digital Interest podcast, McDermott partners Sarah Hogan and Dale Van Demark share their takeaways from the conferences, where they were on the ground and moderating discussions. This episode explores:

  • The role of digital therapeutics in the digital health marketplace
  • The role of the consumer in digital health adoption
  • Forward-looking thoughts on digital health collaborations
  • The importance of data, privacy and trust for the future of digital health solutions

Click here to listen to the full episode.




read more

Available Now – 2019 Digital Health Year in Review

Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product research, development and commercialization, for long-standing and new stakeholders alike. Lawmakers and regulators made meaningful progress towards modernizing the existing legal framework to both protect patients and consumers and encourage continued innovation, but these efforts still lag behind the pace of digital health innovation. As a result, some obstacles, misalignment and ambiguity remain, and 2020 will likely be another year of significant legal and regulatory change.

Click here to read our review of key developments that shaped digital health in 2019 and set the groundwork for trends in 2020.

 




read more

STAY CONNECTED

TOPICS

ARCHIVES

2021 Chambers USA top ranked firm
LEgal 500 EMEA top tier firm 2021
U.S. News Law Firm of the Year 2022 Health Care Law