Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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Former Siemens CMO Donald Rucker to lead ONC

According to a recent string of tweets, Donald Rucker, who served as CMO of Siemens Healthcare for 13 years, will head the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC).

Trump HHS budget proposal raises FDA user fees

President Donald Trump's 2018 budget proposal for the U.S. Department of Health and Human Services (HHS) includes a doubling of U.S. Food and Drug Administration (FDA) user fees, putting added strain on small digital health businesses.

GOA to investigate FDA’s orphan drug program

The Government Accountability Office (GAO) has confirmed it will investigate the U.S. Food and Drug Administrations (FDA) Orphan Drug program following a letter from senators citing possible exploitation.

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Device, drug makers would pay $1 billion extra to FDA under Trump budget

Included in President Donald Trump’s budget proposal for fiscal year 2018 is a big increase in what the medical device and pharmaceutical industries would pay the Food and Drug Administration (FDA) to cover the costs of reviewing their products.

AHIMA releases guidelines for inclusion of LGBT patients

The American Health Information Management Association (AHIMA) has released a brief of guidelines for health information management professionals and clinicians on improving inclusion for patients in the LGBTQ community, covering multiple sexual orientations and gender identities.

AHIMA releases toolkit to assist in preparing for HIPAA audits

The American Health Information Management Association (AHIMA) has released its External HIPAA Audit Readiness Toolkit to assist organizations in preparing for the upcoming Health Insurance Portability and Accountability Act (HIPAA) Phase 2 audits. The toolkit includes Phase 2 aspects for covered entities, business associates and includes tips in meeting responsibilities.

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HIMSS 2017: Four pillars of social media governance

In healthcare, social media is a much more serious affair than a few tweets and Instagram posts. The governance of such activity in healthcare is crucial in the protection of patient data and compliance with HIPAA. Nelly Jacobo, director of digital strategy at Cedars-Sinai, and Melody Smith Jones, manager of Connected Health at Perficient, discussed the four pillars of social media governance at HIMSS 2017.

Lawyers prompt for medical device failure reporting

Technology is prone to breaking from time to time but when the technology within a medical device fails, lives are at risk. Parker Waichman LLP, a law firm protecting patients injured by medical devices, have commented on the safety concerns involving morcellators and duodenoscopes. These comments ask regulators to enforce reporting of medical devices injuries.

Around the web

U.S. health systems are increasingly leveraging digital health to conduct their operations, but how health systems are using digital health in their strategies can vary widely.

When human counselors are unavailable to provide work-based wellness coaching, robots can substitute—as long as the workers are comfortable with emerging technologies and the machines aren’t overly humanlike.

A vendor that supplies EHR software to public health agencies is partnering with a health-tech startup in the cloud-communications space to equip state and local governments for managing their response to the COVID-19 crisis.

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