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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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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Building on momentum from Administrator Seema Verma’s announcement of the MyHealtheData initiative at HIMSS 2018, CMS has published more clues as to future action to liberate health information for patients.

In the CY 2019 call letter to Medicare Advantage organizations and Part D programs, CMS describes the Blue Button 2.0 project and its use of

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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Congress is considering several adjustments to health IT policy which may have significant impact on the Centers for Medicare and Medicaid Services’ (“CMS”) electronic health records (“EHR”) incentives. On July 20th and 21st, Representatives met to discuss bipartisan legislation to improve the Meaningful Use program and introduced legislation that would authorize a CMS Innovation Center (“CMMI”) project to incentivize EHR adoption by behavioral health providers. The bills may be indicative of Congress’ attitude towards the Meaningful Use program, which has garnered criticism from providers for being burdensome.

On July 21, 2017, the House Committee on Energy and Commerce Subcommittee on Health held a hearing on H.R. 3120 and featured testimony from Cletis Earle, Chairman-Elect of the College of Healthcare Information Management Executives. The bill, sponsored by a group of bipartisan lawmakers, will allow CMS to modify the requirements of the Meaningful Use program in order to give the Secretary additional flexibility in implementing the program. Currently, providers and vendors must comply with the Stage 3 measures and objectives of the Meaningful Use program starting January 1, 2018 or be subject to Medicare reimbursement penalties. Earle argued that the implementation timeline for Stage 3 of the program is too rigorous for providers to meet and may lead to an increase in hardship exemption applications. Provider and vendor groups across the industry have suggested that the HHS Secretary Tom Price delay the Stage 3 obligations, noting that software implementation and cybersecurity issues have made the 2018 deadline unreasonable. Sponsors of H.R. 3120 note that the bill will reduce the burden on providers’ use of EHR systems, allowing providers to focus on care coordination and patient outcomes. In response, CMS noted that the proposed “Medicare Program; CY 2018 Updates to the Quality Payment Program,” which is open for comment through August 21, 2017, would give eligible providers an additional year to implement EHR technology that complies with the 2014 or 2015 edition of Certified Electronic Health Record Technology (“CEHRT”) and offers the opportunity to apply for hardship exemptions for the Advancing Care Information performance category of the Merit-based Incentive Payment System (“MIPS”). For more information, see our update on key proposals of the 2018 Proposed Rule here.
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On September 26, 2016, the Office of the National Coordinator for Health Information Technology (ONC) released guidance, entitled EHR Contracts Untangled, to help providers navigate the complexities of electronic health record (EHR) vendor contracting. The guidance breaks down important considerations for selecting EHR systems, and provides strategic pointers – including sample contract language

Crowell & Moring and Accenture co-hosted a conference, “Fostering Innovative Digital Health Strategies,” in late-June. The program aimed to provide a broad analysis of the business and legal issues that must be addressed as health care organizations and technology companies consider innovative strategies to use digital health technologies.

The first session of the conference, “Trends in the Health Care Economy’s Internet of Things,” featured the following distinguished panelists: Zane Burke (president, Cerner); Jodi Daniel (partner, Crowell & Moring); Cheryl Falvey (partner, Crowell & Moring); Melissa Goldstein (assistant director, Bioethics and Privacy Office of Science and Technology Policy, Executive Office of the President); and Kaveh Safavi (senior managing director, Global Health Industry Lead, Accenture).

A series of five videos from the session can be watched below:

Here are key health care Internet of Things (IoT) trends discussed in Session 1:


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On June 23, Crowell & Moring and Accenture co-hosted the Fostering Innovative Digital Health Strategies Conference in Crowell’s D.C. office. The goal of the conference was to take a comprehensive look at all of the business and legal issues that need to be addressed as health care organizations and technology companies are considering innovative strategies using digital health technologies. The conference covered a wide array of digital health topics, including trends in the healthcare Internet of Things, setting up digital health platforms, legislative activity regarding health IT and telehealth, privacy, cybersecurity, and use of digital health technology to support new payment models.

Session 2, “Setting up a Platform for Digital Health,” featured panelists Jodi Daniel (Partner, Crowell & Moring), Bakul Patel (Associate Director for Digital Health, Center for Devices and Radiological Health, FDA), Anna Shimanek (Senior Legal Counsel, CVS Health), Paul L. Uhrig (EVP, Chief Administrative, Legal, & Privacy Officer, Surescripts) and Ronan Wisdom (Managing Director, Accenture Digital).  Key takeaways include:

  • New partnerships are emerging. There is a broad movement among a variety of stakeholders – providers, payors, consumers, technology companies, and the government – toward using digital health to improve communicating with providers and patients’ understanding of their own health. This leads to new opportunities to partner with other organizations and require strategies for doing so effectively from a legal and business perspective.


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Earlier this month, the Office of the National Coordinator for Health Information Technology (ONC) released a report to Congress on the feasibility of creating tools to help providers compare and select certified health IT products. As part of the Medicare Access and CHIP Reauthorization Act (MACRA), Congress required ONC to conduct a study to examine the feasibility of establishing mechanisms to assist providers in comparing and selecting certified EHR technology products. Congress suggested that ONC consider mechanisms like establishing a website of aggregated survey results that would allow meaningful EHR users to directly compare the functionality of certified health IT products. Congress also suggested compiling information from vendors of certified health IT products, and making that information publicly available in a standardized format.

In response to its Congressional directive, and drawing upon recommendations from the Certified Technology Comparison (CTC) Task Force, public input, and its own market analysis, ONC’s report focused on two subgroups of the health care community – providers and comparison tool developers – and identified specific problem areas in the comparison tool marketplace. Ultimately, the report proposed four mechanisms to improve the health IT comparison marketplace:


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