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Utah Provides Structure to Telehealth, Expands Access to Mental Health in Proposed Bill

Utah is one of the many states that started off 2017 with proposals to change its existing telehealth laws and regulations. Proposed Utah HB 154 (the Proposed Bill), endorsed by Ken Ivory and Allen Christensen, amends the regulatory infrastructure for telehealth, with a focus on mental health. Two of the key components of the Proposed … Continue Reading

Texas to Take a Leap Forward in Telehealth – A Proposed Bill Drops the Controversial In-Person Evaluation Requirement

Texas telehealth requirements will significantly change in the near future if Texas Senate Bill 1107 is passed into law, as it removes the controversial “face-to-face” or in-person consultation requirement to establish a physician-patient relationship and lawfully provide telehealth and telemedicine services within the state. This bill comes after a six-year-long battle between telemedicine stakeholders and … Continue Reading

What You Need to Know about Changes to the Common Rule

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data repositories and use of those repositories for secondary research. All stakeholders involved in federally funded research should be aware of the … Continue Reading

HHS Finalizes Overhaul of Federal Human Subjects Research Protections

On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.” These are the first revisions to the Common Rule since its original enactment in 1991, and have been in progress since HHS … Continue Reading

OMB Reviewing Common Rule Overhaul

On January 4, 2017, the Department of Health and Human Services (HHS) submitted a draft final rule to amend the federal human research regulations to the Office of Management and Budget (OMB). These regulations, often referred to as the Common Rule, were originally developed in 1991 and have been adopted by multiple federal departments and … Continue Reading

The Joint Commission Puts the Brakes on Text Messaging Patient Orders

The Joint Commission (TJC) recently clarified that licensed independent providers (LIPs) or other practitioners may not utilize secure text messaging platforms to transmit patient care orders. TJC’s earlier position provided that use of secure text messaging platforms was an acceptable method to transmit such orders, provided that the use was in accordance with professional standards … Continue Reading

Digital Health Solutions are Key to Success under Health Care Payment Innovations

Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held devices—is empowering the innovation needed to meet the imperative for a transition from payment based on volume to payment based on value that is … Continue Reading

Digital Health’s Perfect Storm of Regulators

Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the numerous regulatory bodies responsible for overseeing different aspects of digital health. The following illustration identifies the numerous regulatory bodies that have been … Continue Reading

Bipartisan Legislation Proposes Telehealth Solutions for Effective Chronic Disease Management

Collaborative efforts between congressional offices and various health care stakeholders, as well as the feedback provided in response to the Bipartisan CHRONIC Care Working Group Policy Options Document released in December of 2015, have driven the Senate Finance Committee to introduce a draft of bipartisan legislation known as the CHRONIC Care Act, which seeks to … Continue Reading

ECJ Confirms Dynamic IP Address May Constitute Personal Data But Can Be Logged to Combat Cyberattacks

On 19 October 2016, the European Court of Justice (ECJ) held (Case C-582/14 – Breyer v Federal Republic of Germany) that dynamic IP addresses may constitute personal data. The ECJ also held that a website operator may collect and process IP addresses for the purpose of protecting itself against cyberattacks, because in the view of … Continue Reading

Commercial Insurers Urge Congressional Budget Office to Consider their Telemedicine Data

In hopes of expanding reimbursement opportunities for telemedicine services in the Medicare program, representatives of eleven payers, including Aetna, Anthem, Blue Cross Blue Shield of Tennessee, Cambia Health Solutions and Humana, asked CBO director Keith Hall in a public letter to consider their data when evaluating the impact of Medicare coverage of telemedicine services. Medicare … Continue Reading

OCR Explains How Information Blocking Violates 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 … Continue Reading

FTC Weighs-in on Telehealth, Comments on Delaware’s Occupational Therapy Practice Rule

On August 3, 2016, the Federal Trade Commission (FTC) staff submitted public comments regarding the Delaware Board of Occupational Therapy Practice’s proposed regulation for the provision of occupational therapy services via telehealth in Delaware (the Proposed Regulation).  The FTC’s comments to the Proposed Regulation follow its comments to Alaska’s telehealth legislation earlier this year and evidence its … Continue Reading

Augmented Reality

If you haven’t heard about newest gaming craze yet, it’s based on what is called “augmented reality” (AR) and it could potentially impinge on your home life and workplace as such games allow users to “photograph” imaginary items overlaid with objects existing in the real world. An augmented reality game differs from “virtual reality” in … Continue Reading

Guidance on Low Risk General Wellness Devices Is Finalized

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to … Continue Reading

Brexit Update: The Effect of Brexit on Data Transfers between the United Kingdom and the European Union

With the United Kingdom having voted to leave the European Union (Brexit) on 23 June 2016, the free flow of personal data between the United Kingdom and EU and European Economic Area (EEA) countries is at risk. Even though Brexit will likely have the biggest impact on the financial sector, businesses in the United Kingdom … Continue Reading

Digital Health: An Improving Environment for Investors

The integration of technology into health care delivery is exploding throughout the health industry landscape. Commentators speculating on the implications of the information revolution’s penetration of the health care industry envision delivery models rivaling those imagined by celebrated science fiction authors, and claim that the integration of information technology into even the most basic health … Continue Reading

The Rocky Road of Evaluation for Digital Health Tools

Recent comments linking digital health tools to so-called “snake oil” has the channels of social media atwitter.  (Add this post to the noise!)  While some may decry the comparison, there is a lot we can learn from that perspective. One of the challenges of broad digital health adoption is the simple fact that digital health … Continue Reading

AMA Approves New Ethical Guidance Policy and Encourages Telemedicine Training for Students and Residents

New Ethical Guidelines On June 13, the American Medical Association (AMA) adopted a new ethical guidance policy governing the practice of telemedicine that will be published in the coming months. The policy is based on a report from the AMA Council on Ethical and Judicial Affairs and builds upon the AMA’s 2014 telemedicine guidance. Consistent … Continue Reading

Louisiana Joins its Peers in Removing In-State Barriers to Telemedicine

Last week, Louisiana legislators approved the removal of certain restrictions on the delivery of telemedicine services to residents of Louisiana to encourage the provision of telemedicine services in the state.  H.B. No. 570 was signed by the President of the Senate on June 5, 2016 and sent to Governor John Bel Edwards on June 6, … Continue Reading

FTC Weighs-in on Telehealth: Providing Comments Regarding Alaska’s Proposed Licensure and Standard of Care Requirements

In March 2016, the US Federal Trade Commission (“FTC”) staff submitted public comments regarding the telehealth provisions of a proposed state bill in Alaska demonstrating the FTC’s continued focus on health care competition and general discouragement of anti competitive conduct in health care markets, with a renewed interest and focus on telehealth.… Continue Reading

Developing and Implementing an Effective Telemedicine Informed Consent Form

The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the increased use of telemedicine by providers to reach patients who were previously out of reach, and to provide more timely and cost-effective … Continue Reading

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps that collect, create and share consumer information, including health information. The interactive series of questions and answers augments and cross-references existing … Continue Reading

FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel infrastructure to conduct post-market effectiveness studies. Sentinel is an electronic surveillance system that aggregates data from electronic medical records, claims and … Continue Reading
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