Many Lessons Still Need to be Learned regarding Patient Access to Health Care Information

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.

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Next Generation of Patient Care: Balancing Digital Engagement with Patient and Consumer Privacy

Jennifer Geetter and Lisa Schmitz Mazur wrote this bylined article on the regulatory implications of technology-supported devices, resources, and solutions that facilitate health patient-provider interaction. “Health industry regulators are struggling with how to apply the existing privacy regulatory regime, and the permitted uses and disclosures for which they provide, in this new world of healthcare innovation,” the authors wrote.

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FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program

Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities.

The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar. Continue Reading

Regulating the Internet of Toys

New technologies and the expansion of the Internet of Things have allowed children of this generation to experience seamless interactive technologies through microphones, GPS devices, speech recognition, sensors, cameras and other technological capabilities. These advancements create new markets for entertainment and education alike and, in the process, collect endless amounts of data from children–from their names and locations to their likes/dislikes and innermost thoughts.

The collection of data through this Internet of Toys is on the tongues of regulators and law enforcement, who are warning parents to be wary when purchasing internet-connected toys and other devices for children. These warnings also extend to connected toy makers, urging companies to comply with children’s privacy rules and signaling that focused enforcement is forthcoming.

Federal Trade Commission Makes Clear That Connected Toy Makers Must Comply with COPPA

On June 21 2017, the Federal Trade Commission (FTC) updated its guidance for companies required to comply with the Children’s Online Privacy and Protection Act (COPPA) to ensure those companies implement key protections with respect to Internet-connected toys and associated services. While the FTC’s Six Step Compliance Plan for COPPA compliance is not entirely new, there are a few key updates that reflect developments in the Internet of Toys marketplace. Continue Reading

False Claims Act Settlement with eClinicalWorks Raises Questions for Electronic Health Record Software Vendors

On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments in violation of the False Claims Act.

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Round Two: Significant Telehealth Expansion Re-Proposed in Bipartisan Senate Bill

On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the legislation in early 2016 and referred to the Senate Committee on Finance. As we previously reported on February 29, 2016, this iteration of the proposed bill also focuses on promoting cost savings and quality care under the Medicare program through the use of telehealth and remote patient monitoring (RPM) services, and incentivizing such digital health technologies by expanding coverage for them under the Medicare program—albeit using different terminology. Chiefly, the CONNECT Act of 2017 serves as a way to expand telehealth and RPM for Medicare beneficiaries, makes it easier for patients to connect with their health care providers and helps reduce costs for patients and providers. As with the previous iteration, the CONNECT Act of 2017 has received statements of support from over 50 organizations, including the American Medical Association, American Telemedicine Association, Healthcare Information and Management Systems Society, Connected Health Initiative, Federation of State Medical Boards, National Coalition on Health Care and an array of vendors and health systems. Continue Reading

OIG Reports More Than $731 Million in Inappropriate Medicare Meaningful Use Payments

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

Texas Changes its Tone on Telemedicine

As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been actively monitoring Texas’ approach to telemedicine regulation and the related Teladoc case. Texas has eliminated its most restrictive requirement for delivering care via telemedicine in Texas, increasing opportunities for providers to reach patients using technology.  Senate Bill 1107 was passed on May 11, 2017, and the House added an amendment in passing Senate Bill 1107, which was approved in the Senate on May 18.  The bill was signed into law by Governor Abbott last weekend.

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China’s Network Security Law Comes into Effect: What It Means for Your Company

Today, China’s much anticipated Network Security Law comes into effect after two years of review, revisions over three drafts and a public commenting process. The law is a historical development for China’s legislative coverage of information security and data protections. It also represents one of the strictest approaches in any jurisdiction worldwide, and a continuation of a broader effort at demonstrating the government’s cyber-sovereignty goals through control and regulation of data and the internet.

Overview of the Network Security Law

Commonly referred to as the “Cybersecurity Law,” the new piece of legislation has a broad scope and covers a range of issues related to data privacy, security and cross-border transfers, including:

  • Increasing security measures and strengthening data security through a variety of specific obligations
  • Ensuring consent for collection of personal information through the principles of legality, proper justification and necessity
  • Screening equipment and products for security testing and certification
  • Ensuring real-name registration for users
  • Strengthening requirements to cooperate with government agencies during criminal investigations or to protect national security
  • Requiring personal information to be stored in China under some circumstances
  • Increasing confidentiality measures for user information
  • Setting up a complaint and reporting platform for network security

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Recent $2.5 Million OCR Settlement Is a Warning to Wireless Health Service Providers

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.

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