Health Information Technology

In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on October 29, 2020 that extends the compliance dates under the 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) and offers some technical corrections and clarifications.
Continue Reading Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule

Access to healthcare information (or lack thereof) has always been touted as one of the key factors/necessities to realizing the promise of technology in the delivery of healthcare. Despite various legislative, judicial, patient and industry initiatives, access continues to be a challenge due to a variety of competitive practices and lack of capabilities. Consider the following events and whether they signal real progress:

  1. In a September 9, 2019 Press Release issued by the United States Department of Health & Human Services – Office of Civil Rights (“OCR”), the OCR announced that it had taken action against Bayfront Health St. Petersburg (“Bayfront”), an academic medical center in St. Petersburg, Florida, to enforce the Health Insurance Portability and Accountability Act (“HIPAA”) protections that guarantee every patient the right to receive copies of his/her medical records promptly and without being overcharged. The enforcement action against Bayfront (which includes the assessment of an $85,000 fine against Bayfront and the imposition of a “Resolution Agreement” between OCR and Bayfront) is notable as the OCR’s first enforcement action under the OCR’s “Right of Access Initiative” – a program designed to focus OCR resources on the enforcement of HIPAA’s right of access guarantees.
  2. On February 11, 2019, two offices of the US Department of Health and Human Services (“HHS”) — the Office of the National Coordinator for Health Information Technology (“ONC”) and the Centers for Medicare and Medicaid Services (“CMS”) – each released a proposed rule (ONC Proposed Rule; CMS Proposed Rule) (collectively, the “Proposed Rules”) aimed at enhancing the interoperability of electronic health record (“EHR”) systems and increasing patient access to electronic health information (“EHI”) as required by the 21st Century Cures Act.
  3. On September 23, 2019, seven major healthcare leadership groups, including the American Health Information Management Association (“AHIMA”) and the American Medical Association (AMA), sent a letter to Congress (the “AHIMA Letter”) critiquing the ONC Proposed Rule.

What is the link between the Bayfront case, the Proposed Rules, and the AHIMA letter? The link is commonly referred to as “Information Blocking.”
Continue Reading INFORMATION BLOCKING AND THE RIGHT TO ACCESS INITIATIVE: Why Patients Struggle to Obtain their Medical Records and what the Office of Civil Rights Intends to Do About It

Healthcare Information and Management Systems Society (HIMSS) kicked-off its annual global conference this week in Orlando, Florida, addressing leading topics in healthcare information technology. Over 45,000 healthcare and information technology professionals and 1,300+ vendors are expected to attend the week long event.  
Continue Reading HIMSS19 Kicks-Off Addressing Leading Topics in Healthcare Information Technology

This follows the blog article posted November 28, “Connection and Innovation Take Center Stage at the Patient ENGAGE Conference” and is the second feature regarding the MedCity ENGAGE conference Nov. 6-7 in San Diego. Here, we focus on the aspects of the conference that explored the impact of technology on patient engagement, from wearables to DNA sequencing, to apps used by insureds to quit smoking while reducing insurance premiums in the process.
Continue Reading Patient Empowerment Through Technology is Focus of ENGAGE Conference

On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online pharmacies – such risks including the dispensing of drugs (including addictive drugs to be used recreationally) without a valid prescription, and the dispensing of adulterated drugs, counterfeit drugs, and/or expired drugs, all of which could result in significant harm to individuals who may have been looking for an easy way to obtain prescribed medications at a lower price.
Continue Reading Giving Telemedicine More Room to Breathe: Recent and Pending State and Federal Actions in the World of Online Prescribing

The Office of the National Coordinator for Health Information Technology (ONC) has released a final rule (Final Rule) introducing a new regulatory framework for certified health information technology (Health IT). The use of certified Health IT—specifically, electronic health record (EHR) modules—has played a central role in the EHR Incentive Programs and is intimately linked to the accrual of points in MACRA’s Merit-based Incentive Payment System. A major component of the Final Rule allows for ONC’s direct review of products certified by ONC’s Health IT Certification Program (Program) and identifies the roles of both developers and the ONC in addressing Program-compliance issues.[1] The Final Rule impacts developers of certified Health IT (Health IT Developers), providers that utilize and rely on such certified Health IT, and ancillary developers and service providers whose businesses are linked to EHR technology.
Continue Reading A Stick to Balance the Carrot: ONC Finalizes a New Framework to Address Non-Conformities in Certified Health Information Technology

Rightly or wrongly, Mississippi is not generally regarded as a leader in health. The state, which opted out of the Affordable Care Act (ACA) Medicaid expansion, consistently ranks in the bottom two states for most health indicators: infant mortality and low birth weight, obesity, cancer deaths, and diabetes outcomes.  Mississippi, however, is making significant efforts to be  a leader in telehealth. In 2014, the state initiated The Diabetes Telehealth Network, the first program of its kind to provide remote diabetes management and specialty care to rural, medically underserved populations in the Mississippi Delta through internet-capable computer tablets. Mississippi’s telehealth model is gaining national attention for its promise of significant cost-savings by preventing complications and hospital admissions while reducing the demand for expensive specialty services.
Continue Reading Mississippi Advances with Telehealth, Shows Promise for Improved Diabetes Disease Management

With the advent of an increasing aging population, physicians and other healthcare providers are seeking alternative approaches in offering patients access to quality health care.  Among the innovations in healthcare delivery is the practice of shared medical appointments, where one or more healthcare providers (e.g. physicians and nurses) will see a group of eight to 15 patients with similar medical conditions at the same time.
Continue Reading Healthcare Systems Offer Shared Medical Visits to Address Physician Shortages and Chronic Illnesses

Accessories are an everyday reality for almost all users of technology products today.  They can help improve efficacy, increase usability and make many other improvements to the technology we use.  Increasingly, accessories are used for health related applications (e.g., smartwatches that connect to glucose meters).  In the healthcare space, accessories can potentially face regulation by the Food and Drug Administration (FDA) if they are intended to support, supplement, and/or augment the performance of one or more regulated parent devices, but there has been a lack of clarity from the FDA on what types of accessories will be regulated.  In January 2015, the FDA released guidance[1] to address concerns from the medical device industry and more recently the health information technology industry on the following topics.
Continue Reading Go For De Novo: FDA’s Revised Approach to Medical Device Accessories

2015 has been a busy year for the Food and Drug Administration (FDA).  In January, the FDA issued guidance documents addressing wellness applications[1] as well as accessories to medical devices and it looks like the administration is continuing the trend into February with a finalized regulatory approach to Medical Device Data Systems (MDDS)[2].  All three of these documents seemed to trace a common line of promoting health information technology (HealthIT) innovation and demonstrate the prevalence the field has had into the FDA’s thinking.  Before addressing the applicability to HealthIT, we briefly examine the impact the current guidance has on MDDS regulation.
Continue Reading Interface without Regulation – FDA Deregulates MDDS and Related Technologies

On January 20, 2015, the FDA issued draft guidelines[1] designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as medical devices under Section 201(h) of the Food Drug & Cosmetics Act (the “Act”) and are therefore subject to the Act’s regulatory requirements for devices.
Continue Reading FDA Issues Guidance for Low-Risk General Wellness Products