EHR - Electronic Health Record
Everyone is talking about the EHR as of now and in the medical sector is eagerly awaiting what will happen on January 1st 2021, when the EHR will be established by all health insurance companies for all those with statutory health insurance.
But what does the EHR have to be capable off and who will be legally responsible?
Find out in our latest Whitepaper!
The Medical Science Community - Ambulatory Medicine as a Commercial Service of a Legal Person under Private Law
"You can't do that!" or "You aren't allowed to do that!" a lot of people will say now. But is this true?
Wherever you look, you will find commercial providers in the field of outpatient medicine and especially start-ups that combine digital services with outpatient medical services from a distance are increasingly pushing into the already competitive market.
Reason enough that we have dealt with exactly this question in our latest whitepaper. The result will surprise you...
Positive Supply Effects According to the Draft of the Digital Healthcare Act
The draft of the Digital Healthcare Act (DVG) in the version of 10.07.2019 by the Federal Ministry of Health under Jens Spahn has already been confirmed by the Federal Cabinet and will be passed by parliament in the course of the year. The new regulations are to come into force at the beginning of 2020.
The DVG is a core project of Spahn's agenda to advance the digitization of the health care system. It essentially amends and supplements Volume V of the Social Insurance
Code (Fünftes Buch Sozialgesetzbuch - SGB V), in which the regulations for the reimbursement of health services in the statutory health insurance system are laid down. According to the DVG, patients with statutory health insurance are entitled to benefits for the provision of so-called "digital health applications", or diGa for short. In future, these can be prescribed by a doctor and paid for by the health insurance companies.
The so-called "positive care effect", which will be described in more detail in this white paper, is decisive for the reimbursability of diGas.
Medicine-Apps and the MDR
The EU Medical Device Regulation (MDR) will adapt, concretise and partially re-regulate the medical device law. It came into force on 25 May 2017 and will be mandatory from 26 May 2020. Those affected by the MDR will have to deal with it decisively. This is the only way they can filter out where new regulations actually have to be taken into consideration and where the familiar patterns can (still) be followed.
The focus of this whitepaper is on digital medical devices, especially medical apps. The MDR has introduced innovations, especially concerning classification. Here, the entire medical device industry, and thus also the app developers, will have to question what effects they can expect for the distribution of their specific product.
Exclusive Remote Treatment - In For a Penny, in For a Pound?
At this year's German Medical Council in Erfurt, it was decided to relax the regulations of the Model for the Professional Code of Conduct for Doctors (MBO-Ä) concerning remote treatment. This formed the basis for exclusive remote treatment.
As some time has passed since the decision was made, it's time to have a look at the development so far. This whitepaper is intended as a supplement to our previous whitepaper on remote treatment and brings you up to date on the legally interesting topics of exclusive remote treatment.At this year's German Medical Council in Erfurt, it was decided to relax the regulations of the Model for the Professional Code of Conduct for Doctors (MBO-Ä) concerning remote treatment. This formed the basis for exclusive remote treatment.
As some time has passed since the decision was made, it's time to have a look at the development so far. This whitepaper is intended as a supplement to our previous whitepaper on remote treatment and brings you up to date on the legally interesting topics of exclusive remote treatment.
Data Protection in (Medical-) Practice
We all knew it was coming, and yet, in the end, it seemed that everyone was taken by surprise. On May 25th 2018, the much "feared" Data Protection Regulation, or GDPR for short, came into force.
Unfortunately, many people are subject to the misconception - fired up by various consultants and the media - that the GDPR has practically "reinvented the wheel" and covered the data protection landscape with previously unknown innovations. Reality begs to differ.
In this Whitepaper, we want to answer the five most frequently asked questions by our clients in the health care sector regarding the GDPR. These questions are:
1) "Do I have to get a new written consent from my patients?"
2) "Do I need a data protection officer now?"
3) "Do I have to delete my patient's data at his request?"
4) "Am I allowed to send emails to my patient?"
5) "Bureaucracy kills me. What documents do I need?"
Exclusive Remote Treatment - an Outlook on Possible Follow-up Problems
Press release of the German Medical Association of 10.5.2018:
"The 121st German Medical Association in Erfurt today adopted by an overwhelming majority a new version of Section 7 (4) of the (model) professional code of conduct for doctors working in Germany, thus paving the way for professional law for the exclusive remote treatment of patients. (…)“
What sounds so euphoric can only speak of good things up ahead. But as it is often the case, there are two sides to this coin. Apart from opening up the possibility of exclusive remote treatment, which particularly welcomed, the legal issues outside the MBO field must not be lost sight of in all the euphoria.
Our current whitepaper deals in a clear and concise manner with the essential consequential problems of exclusive remote treatment. In particular, it takes up the requirements of the German Drug Law, the German Medical Doctors' Agreement and the German Drug Directive.