While digital health innovation empowers us to better manage our health and live more productive lives, it also poses myriad regulatory, strategic and operational challenges. Edited and authored by McDermott’s team of distinguished digital health lawyers, The Law of Digital Health offers an overview of the highly dynamic and integrated components of the digital health ecosystem, with the goal of helping businesses thrive in this ever-evolving landscape. Over five chapters, we explore a broad spectrum of digital health innovation opportunities and the corresponding value proposition; review current and evolving legal and regulatory frameworks, theories, interpretations, and policy and enforcement initiatives in both the public and private sectors; and provide practical planning and implementation strategies for achieving the appropriate balance between the benefits of digital health innovation opportunities and the need to manage associated legal and regulatory risks.
Amanda Enyeart maintains a general health industry and regulatory practice, focusing on fraud and abuse, information technology and digital health matters. Amanda advises health care industry clients in all aspects of software licenses and other agreements for the acquisition electronic health record (EHR) systems and other mission critical health IT. Amanda’s health care IT transactional experience also includes advising clients with respect to software development, maintenance, service and outsourced hosting arrangements, including cloud-computing transactions. Read Amanda Enyeart's full bio.
The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US Department of Health and Human Services (OIG) describing inappropriate payments to physicians under the program. The report follows on the heels of a high-profile settlement under the False Claims Act between the US Department of Justice and an EHR vendor related to certified electronic health record technology (CEHRT) used in the EHR Incentive Program (which we’ve previously discussed in-depth).
The OIG reviewed payments to 100 eligible professionals (EPs) who received EHR incentive payments between May 2011 and June 2014 and identified 14 inappropriate payments. OIG extrapolated the results of the review to the 250,470 total EPs who received incentive payments during that time period and estimated that CMS made approximately $729 million in inappropriate EHR incentive payments out of a total of just over $6 billion in such payments during the review period. Continue Reading OIG Reports More Than $731 Million in Inappropriate Medicare Meaningful Use Payments
On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on the impermissible disclosure of unsecured electronic protected health information (ePHI) by a provider of remote mobile monitoring, with a focus on patients who are at risk for cardiac arrhythmias.
In January 2012, the remote monitoring company reported that a workforce member’s laptop containing the ePHI of over a thousand individuals was stolen from a parked vehicle outside of the employee’s home. A little over one year later, the same company reported a second breach that compromised the ePHI of twice as many individuals (details regarding this breach were not provided by OCR).
OCR’s investigation revealed that the company allegedly had insufficient risk analysis and risk management processes in place at the time of the theft. Additionally, the company’s draft policies and procedures implementing the standards of the HIPAA Security Rule had never been implemented, and the company was also unable to produce final versions of any policies or procedures regarding the implementation of safeguards for ePHI, including those for mobile devices.
In its tenth OCR Cyber Awareness Newsletter of the year (Newsletter), the Office for Civil Rights (OCR) reminded HIPAA-covered entities and business associates of the importance of selecting an appropriate authentication method to protect electronic protected health information (ePHI). Authentication is the process used to “verify whether someone or something is who or what it purports to be and keeps unauthorized people or programs from gaining access to information.” The Newsletter notes that the health care sector has been a significant target of cybercrime and that some incidents result from weak authentication methods.
Authentication methods can consist of one or more factors and are often described as: (1) something you know, such as a password; (2) something you are, such as a fingerprint; or (3) something you have, such as a mobile device or smart card. Single-factor authentication requires use of only one of the methods. Multifactor authentication requires use of two or more methods (for example, a password prompt followed by an additional prompt to a mobile device). Continue Reading OCR Guidance Underscores Importance of Authentication under HIPAA
The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently posted guidance (OCR guidance) clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a covered entity customer to protected health information (PHI) maintained by the vendor on behalf of the customer. Such “information blocking” could occur, for example, during a contract dispute in which a vendor terminates customer access or activates a “kill switch” that renders an information system containing PHI inaccessible to the customer. Many information vendors have historically taken such an approach to commercial disputes.
Read full article here.
During 2014, the Office for Civil Rights (OCR) of the U.S. Department of Health & Human Services initiated six enforcement actions in response to security breaches reported by entities covered by the Health Insurance Portability and Accountability Act (HIPAA) (covered entities), five of which involved electronic protected health information (EPHI). The resolution agreements and corrective action plans resolving the enforcement actions highlight key areas of concern for OCR and provide the following important reminders to covered entities and business associates regarding effective data protection programs.
- Security risk assessment is key.
OCR noted in the resolution agreements related to three of the five security incidents, involving QCA Health Plan, Inc., New York and Presbyterian Hospital (NYP) and Columbia University (Columbia), and Anchorage Community Mental Health Services (Anchorage), that each entity failed to conduct an accurate and thorough assessment of the risks and vulnerabilities to the entity’s EPHI and to implement security measures sufficient to reduce the risks and vulnerabilities to a reasonable and appropriate level. In each case, the final corrective action plan required submission of a recent risk assessment and corresponding risk management plan to OCR within a relatively short period after the effective date of the resolution agreement.
2. A risk assessment is not enough – entities must follow through with remediation of identified threats and vulnerabilities.
In the resolution agreement related to Concentra Health Services (CHS), OCR noted that although CHS had conducted multiple risk assessments that recognized a lack of encryption on its devices containing EPHI, CHS failed to thoroughly implement remediation of the issue for over 3-1/2 years.
3. System changes and data relocation can lead to unintended consequences.
In two of the cases, the underlying cause of the security breach was a technological change that led to the public availability of EPHI. A press release on the Skagit County incident notes that Skagit County inadvertently moved EPHI related to 1,581 individuals to a publicly accessible server and initially reported a security breach with respect to only seven individuals, evidentially failing at first to identify the larger security breach. According to a press release related to the NYP/Columbia security breach, the breach was caused when a Columbia physician attempted to deactivate a personally-owned computer server on the network, which, due to lack of technological safeguards, led to the public availability of certain of NYP’s EPHI on internet search engines.
4. Patch management and software upgrades are basic, but essential, defenses against system intrusion.
OCR noted in its December 2014 bulletin on the Anchorage security breach (2014 Bulletin) that the breach was a direct result of Anchorage’s failure to identify and address basic security risks. For example, OCR noted that Anchorage did not regularly update IT resources with available patches and ran outdated, unsupported software.
5. HIPAA policies and procedures that merely sit on the shelf are not sufficient.
OCR noted the failure of two covered entities to follow policies and procedures that each entity had adopted. In the NYP resolution agreement, OCR noted that, with respect to a data sharing arrangement with Columbia, NYP had “failed to comply with its own policies on information access management.” Similarly, OCR noted in the 2014 Bulletin that its investigation of Anchorage revealed that Anchorage “had adopted sample Security Rule policies and procedures in 2005, but [that] these were not followed.”