In order to move health care organizations towards consistency in mitigating important cybersecurity threats to the health care sector, the Department of Health & Human Services (HHS) published multiple guidance documents on best practices for health care organizations to reduce cybersecurity risks (“HHS Cyber Guidance”). The HHS Cyber Guidance is the result of HHS’ public-private partnership with more than 150 cybersecurity and health care experts. While compliance is voluntary, this guidance serves as direction to health care entities on important practices that should be considered and implemented to reduce risk.

Why HHS has published this guidance


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  • More of our health information is becoming digital every day, as new technology companies enter the health care and wellness markets.
  • Many companies that hold a wealth of consumer health information are not covered by HIPAA.
  • Many consumers may not realize that their health information only is protected and they only have certain rights with respect to that information when it is held by certain entities, but not when it is held by others.
  • The private sector should work with regulators to develop a common sense, appropriate framework for use of health information by non-HIPAA covered entities.

As we await proposed HHS regulations on interoperability and patient access to data, and as more companies than ever before are collecting and using data to power advanced data analytics, artificial intelligence, and machine learning to improve health care quality and delivery, it is important to understand the scope and limitation of protections and the applicability of the HIPAA Privacy Rule.

Patients, providers and caregivers now have access to a wide array of devices and applications to manage and track patient health, improve treatment adherence, and better coordinate care. Large technology companies, athletic gear manufacturers, and others are entering a rapidly growing consumer health technology market. They are developing new technologies including tracking apps, wearables, and social networks that are increasingly integrated into patients’ daily lives. 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, creating a significant gap in consumer protections.

At the same time, HHS is pushing for greater interoperability and patient access to data to address a challenge that remains widespread even after the investment of billions of federal dollars into the adoption of electronic health records. Agencies are encouraging and mandating easier availability of electronic health data, through current and anticipated CMS and ONC regulations and through a variety of government initiatives such as: 1) Blue Button and MyHealtheData; 2) incentivizing the adoption of open APIs; 3) developing new fee-for-service payment policies regarding remote monitoring and virtual care reimbursement; and 4) launching Sync for Science, a technical standard for facilitating patient-mediated data exchange for research. Consumers and companies alike seek guidance on the implications of collecting, storing, maintaining, and commercializing personal health data.
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The Centers for Medicare & Medicaid Services (CMS) recently proposed a rule to allow Medicare Advantage plans to expand telehealth benefit coverage. (See alert for more detail) This proposed rule implements the statutory provisions in section 50323 the Bipartisan Budget Act of 2018. What you might not know, however, is that the Bipartisan Budget Act of 2018 is only one of many legislative vehicles by which advocates for telehealth expansion have been able to move the needle definitively in their favor during this session of Congress.

Over the past two years, Congress has shown its support for the utilization of telehealth by introducing forty-one bills that, if passed, would require Medicare to reimburse providers for their use of telehealth to treat numerous health conditions such as stroke diagnosis, mental health, chronic care management and opioid addiction treatment. Of note, the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 was the predecessor bill that passed out of the Senate in September of 2017 and became law on February 9, 2018 as a part of the Bipartisan Budget Act of 2018.
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CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market.

Virtual Check-Ins

CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.”
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Yesterday, the FDA released draft guidance on the management of cybersecurity in medical devices submitted to the agency for premarket review. Noting that cybersecurity threats to the healthcare sector have increased in number and severity, the FDA offered new recommendations for device design, labeling, and documentation that medical device manufacturers will need to consider during premarket submission processes.

The guidance comes shortly after the FDA’s launch of its Medical Device Cybersecurity Playbook, which provides a framework for healthcare delivery organizations to use in preparing for and responding to cybersecurity threats against patient medical devices.

Given rapid changes in technology and increasing innovation in the digital health market, the guidance intends to decrease the risk of cyberattacks that could render medical devices inoperable and potentially harm patients. Comments on the draft guidance are due on March 18, 2019.
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Next week, on June 21, 2018, attorneys from Crowell & Moring will hold a bootcamp entitled “Early Stage Investing in Health Technology.” Crowell & Moring attorneys will present on topics of interest to entrepreneurs, investors, and early stage health technology companies. Attendees will have the opportunity to learn about a range of matters including formation

This blog post has been prepared in collaboration with Validic. Mr. Schiller is CEO of Validic. Jodi Daniel is a partner in Crowell & Moring’s Health Care Group in Washington, D.C.


Our healthcare system is in the midst of a fundamental shift toward value-based care to drive down costs and improve the quality of care. We won’t be able to achieve that goal without technology that allows providers to collect and use health data and puts patients front and center. Patient access to clinical and claims data is essential. When patients have access to their own information, they can better understand their condition and feel empowered to ask questions and shape their own care plan.

Congress and the federal government are pushing to liberate data from within the healthcare system and to promote patient access to health information. However, it is equally important to focus on the flow of data from the patient back into the healthcare system. The patient – who is gathering data at home, managing her condition, and making day-to-day decisions that impact her health – holds information that is critical to treatment decisions and outcome improvements.
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On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market.

The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request seeking $70 million to create a Center of Excellence on Digital Health that would, among other things, craft new regulations for third-party certification for developing medical devices. This comes as FDA is pushing guidance and innovative approaches for oversight of digital health (see our blog).

According to FDA Commissioner Scott Gottlieb’s announcement, the FDA’s plan organized into five points that seek to balance patients’ timely access to devices and safety and effectiveness.
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The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation.

During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and outlined how the agency is committed to moving the ball forward in health care innovation through the following initiatives:
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On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the White House Office of American Innovation, in collaboration with the Department of Health and Human Services (HHS), CMS, the Office of the National Coordinator for Health Information Technology (ONC), the National Institutes of Health (NIH), and the Department of Veterans Affairs (VA). (CMS press release here.)
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